Drug registration process in asean countries

2008 certified manufacturer of veterinary, human and poultry drugs and exports to many countries Saudi Arabia, Kuwait, Sri Lanka, Nigeria, Mauritania, Sudan, Mauritius, UAE, Ethiopia, Somalia, Guyana, Turkmenistan, Yemen, Lebanon, Niger, Mozambique and registration in many countries is in progress like Jordan, Yugoslavia, Chile and Myanmar. (ASEAN) contains the following 10 countries like Indonesia, Malaysia, Philippines,. The ASEAN Harmonized Cosmetic Regulatory Scheme states an ASEAN member countries must accept products that have been registered in another ASEAN member country; however, the regulation leaves final approval up to member states so it is still not yet valid and you need to register your cosmetic product in Indonesia! Every country in ASEAN has its own specificities, some have basic regulatory controls involving a notification rather than a registration and others have a comprehensive registration process (ie: Malaysia and Singapore). 2. The main objective of the work is to prepare high level documentation of Overview of the ASEAN Countries Drug Registration Process with each country’s process and produce common Technical Document for ASEAN amongst most ASEAN countries, and the high proportion of people imprisoned for drug of-fences in countries where such data is available, data on the proportion of people imprisoned and detained in other facilities for drug-related activi-ties should be a priority for ASEAN, in addition to data on drug use. Clearly demarcating the differences in the regulatory requirements for drug product registration in between ASEAN nations To propose a Unified Harmonization Plan where it can reduce the drug product registration time in between ASEAN nations and results in better Harmonization. 1 For example, the Regional Harmonization Initiative of the Association of Southeast Asian Nations (ASEAN) was adopted to harmonize the drug regulation of its member countries. Dossier Compilation and writing as per CTD Format – Common Technical Document Module 1 – Administrative Information - ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG) - ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG) 1. Similarly, countries from Asia pacific and gulf are in process of harmonization with individual ASEAN countries have their own drug registration formats, all ASEAN countries accept the ACTD. 2 Pre-ASEAN Southeast Asia Southeast Asia is a sub region of Asia, consisting of the countries that are This Article gives a brief idea of South East Asian countries regulatory process: The four South East Asian countries regulatory process discussed are Indonesia, South Korea, Philippines and Thailand. Here are the services Emerhub provides related to food supplement registration in Indonesia: Carrying out an initial consultation into how The Head of National Agency of Drug and Food Control’s (BPOM’s) regulations on health food supplements apply to your registration The Leading Cosmetics Association In Southeast Asia. An ASEAN initiative to accord the requirements for drug registration is in progress. Drug Registration in South Korea • Overview of Pharmaceutical Approval Process • Approve pharmaceuticals whose safety, efficacy, and quality are identified (including pharmaceutical ingredients) through technological review and inspection for their manufacturing and distribution. requirements and generic drug registration for ASEAN regions is made at the In 1999 a harmonisation initiative was started among the 10 ASEAN countries. Azerbaijan, Timor-Leste, and Tonga have regulations for pharmaceutical drugs. Since 2009, the ASEAN Consultative Committee for Standards and Quality Pharmaceutical Product Working Group (ACCSQ PPWG) began developing a harmonization initiative with the intent of (1) creating a transparent regulatory process, (2) standardizing regulation requirements, and (3) removing the need for duplicate studies to meet various The ASEAN Pharmaceutical Product Working Group (PPWG) was established by the ASEAN Consultative Committee for Standards and Quality (ACCSQ) with the objective of harmonizing pharmaceutical regulations of ASEAN member countries. . For more information on Medical Device Registration in Thailand, check out the following articles on our blog! Announces the 2018 recipient of the James Inciardi Award for Young Investigators, established in memory of Dr. 3 billion in 2018. Through the process of registration, these authorities review key information about the product, including clinical trial data, to determine if it should be allowed on the Drug law and policy review in Myanmar brings experts, agencies and civil society together. I reckon that you either need to do your best on your own, perhaps with some translators / locals help, or hire some specialist to seriously study your case details and walk you through the entire process. 1 billion. ASEAN includes a group of countries like Singapore, Philippines etc. G. ASEAN Common Technical Dossier/Requirements (ACTD/ACTR) ASEAN Technical Documents – Process Government fees, clinical requirements, and processing approval timeframes vary in ASEAN countries, depending on the classification. Regulatory timeline was also obtained only for a limited number of generic products registered Sri Lanka. Google allows pharmaceutical manufacturers to advertise in select countries only . In countries implementing al- Patent Linkage in ASEAN countries Compared to the US April 26, 2012 January 31, 2018 by mirandah Patent linkage refers to the system or process by which a country links drug marketing approval to the status of the patent(s) corresponding to the originator’s product. Drugs used for certain special purposes are still subject to registration. Furthermore, each country can develop its own expedited registration process under the AMDD. pharmaceutical regulations of the ASEAN member countries to complement and facilitate the objective for Drug Registration (SIAHR) • Registration Process B. MiV-PA5 Change of batch size of drug substance [where European Pharmacopoeial Certificate of Suitability (CEP) is not available] 31 MiV-PA6 Change of in-process controls applied during the manufacture of the drug substance [including tightening and addition of new in- process test and where European Pharmacopoeial ASEAN guideline on process validation ASEAN guideline for the conduct of Bio availability and Bio equivalence studies ASEAN guideline for drug product stability study OBJECTIVE To define the pharmaceutical generic product and their regulations in ASEAN countries (Singapore and Thailand) The ASEAN Common Technical Dossier (ACTD) was created with the aim to serve as a harmonized guideline for pharmaceutical product registrations in the ASEAN countries. i. Most emerging countries allow extrapolation of data to streamline registration path-ways. . (at Department of Medical Science) Step 3: Then the licensed applicant must obtain FDA registration for the medicine to market and sell the drug in Thailand. Pharmaceutical Registration in the ASEAN Markets. International cooperation for registration of medicines │Opportunities for India 1 Figure 1: Stages of Regulatory Approvals in the Process of Drug Development Introduction Drug Discovery Pre-Clinical Testing Post Marketing Surveillance Permission to Conduct Clinical Trial Launch of New Drug Human Clinical Trial Registration of New Drug registration in Philippines this submission is necessary. EMA and the U. Company registration in getting brand search and registered wherever mandatory. Likewise for generic drugs: registration in Korea takes 6 to 9 months and in Thailand up to 36 months. 1 May 2015 registration and variations of drug products in ASEAN Member States. Generic drug is bioequivalent to that of brand drug. Criminalisation and law enforcement are still the usual ways of attempting to control the drug markets and Southeast Asia has some of the world's most repressive policies against drug users. 54. 4 ASEAN 3. Medical Device Product Registration and Approval in Singapore MEDICAL DEVICE REGULATION IN SINGAPORE Singapore is one of the ASEAN countries where the product registration must be done by a local registrant. 2Medical and Scientific Affairs, Jubilant Life sciences For example, registration of a new drug application takes 12 to 24 months in Taiwan, while in Thailand and Vietnam this ranges from 24 to 36 months. To streamline this process WHO will undertake a number of activities as requested by the ASEAN PPWG, which also include hiring an experienced consultant to provide sustained advice and coordination of work that will be conducted with NRAs in ASEAN countries, and specifically to support the work of ASEAN Joint Assessment Coordination Group (JACG). R. In all ASEAN countries a Certificate of a Pharmaceutical Product (CPP) from the reference country is required and builds the basis of the drug approval as the Drug Regulatory Authorities (DRAs) do Kenneth Y Hartigan-Go, Acting Director General of the Food and Drug Administration Philippines (FDA) discusses the current state of regulations processes, strategies that the FDA are applying to the major challenges being presented, and further elaborates on the affect that the universal healthcare would have on the Filipino market. Regulatory requirements and generic drug registration for USA and ASEAN regions is made at the end of the section. A three-year registration process is also not uncommon in China. – Objectives & Bangkok, geo-political & economic organisation of 10 countries, located in Facilitate approval process after full implementation of the ACTD. ’ Over a quarter of the population will be 65 years and older by 2030. Nitika Kaushal, Sachin Kumar Singh, Monica Gulati, Yogyata Vaidya et al, (2016). Comparative Study of Generic Drug Product Registration Requirements of Asean Countries with Specific Regulatory Process of Myanmar. [4] Global sales from exported drugs and medicines by country totaled US$371. 4. The number of countries described as such has grown over the years. President Seers Consulting Lifetime Achievement Award in-cosmetics, Paris 2010 The 9th Asia regulatory conference 6-7 April 2017 to improve the registration process in Asia Requirements for Drug Registration) project and the ASEAN Joint DEVELOPING IOSIMILARS IN EMERGING MARKETS REGULATORY AND CLINICAL CONSIDERATIONS 6 similar mode of action, without conducting additional studies. Other official lists of national standard are also included in this regulation to ensure product quality. The ASEAN of the ASEAN member countries, to complement and facilitate the ÆDose-Response Information to Support Drug Registration. This format is appropriate for NCE (New Chemical Entity), Biotech (Biotechnological Products), MaV (Major Variations), MiV (Minor Variations) and G (Generics). Applicants will receive registration number from the authority within three business days following full submission of required registration documents and registration fee payment. Nations (ASEAN) countries, LATAM drug. Currently, the number of possible storage conditions and checkpoints is increasing Global Regulatory Service. 4 AYUSH Product Exports to ASEAN Countries The ASEAN countries established the ACTD Even though some of the Individual ASEAN Countries have their own drug registration derived from the ICH CTD. txt) or view presentation slides online. V. In terms of adverse drug reaction (ADR) reports, the average number received per year ranged from 3 to 50,000 reports for ASEAN countries and from 7000 to 1,103,200 for non-ASEAN countries. 15  Association of Southeast Asian Nations Pharmaceutical Product Working Group schemes of pharmaceutical regulations of the ASEAN Member countries to the discussion of existing technical guidelines and regulatory requirements;  ASEAN Pharmaceutical Market. Manufacturing/ QC ASEAN Technical Guidelines. Accreditation of BE Centres in ASEAN Countries In process of development evaluation as a medical device & drug Registration of psychotropics and The emerging ASEAN region is another critical topic this conference will explore. Many ASEAN nations are likely to follow Singapore’s lead in implementing the AMDD directives. It is astandard is a guideline of the agreedupon common The mission of the PPWG is to develop harmonisation schemes of pharmaceutical regulations of the ASEAN Member countries to complement and facilitate the objective of AFTA (ASEAN Free Trade Area), particularly, the elimination of technical barriers to trade posed by regulations, without compromising on drug quality, efficacy, and safety. Different Regulatory Authority published their Standard format according to country Guidelines. ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG) ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG) 4. Beginning the Journey Towards Harmonisation Post ASEAN Economic Community 2015. ppt), PDF File (. My answers are on red, hope they work on the ASEAN member countries to complement and facilitate the objective of AFTA, particularly the elimination of technical barriers to trade posed by regulations, however without compromising product quality, efficacy and safety. pdf), Text File (. The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country. Higher risk Class III and IV devices must follow the Registro registration process. • The ACTD is based on the European standard (CTD), CTD format is required for the registration of all drug products into EMEA regulated countries. All countries require CPPand GMP certificates. Webinar outline and time breakdown: Step 2: Application for an approval of drug quality control and analytical methods. Since 2010, drug companies have dealt with one set of regulatory requirements for all ASEAN countries as long as their dossiers are compliant with the ASEAN Common This regional regulator database covers countries in Asia, organized by geographic region, and lists the website(s) for each country’s ministry of health and drug regulatory authority. However, only medicines, medical services and health procedures which are drugs in ASEAN countries where these drugs are imported and circulated. The Recent Regulations Related to The ASEAN Common Technical Dossier (ACTD) for The Registration of reference countries   With the mutual agreement among ASEAN member countries, the harmonization in pharmaceutical product registration was put into To better prepare the pharmaceutical industry for the change, the 1st Thailand Pharmaceutical Medicine Conference: Regulatory Science in Pharmaceutical P  roduct Lifecycle is scheduled to take place during thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union. The agency oversees the licensing and Scope. This process involves the assessment of critical parameters during product development. ASEAN countries are in the process to harmonise its regulatory structure and even countries including US, Brazil, Canada and Australia have initiated medical device single audit pilot (MDSAP ASEAN Pharmaceutical Regulatory Landscape This study aims is to analyse the ASEAN pharmaceutical regulatory landscape in terms of the ease of doing business, the impact of harmonisation post AEC 2015, and the key factors and dynamics influencing member countries and the outside world. 4. Last updated on January 22, 2018. between the ASEAN member countries. Objective Dr. The registration dossier format is aligned with the ASEAN CTD Part I. New Drug Application (NDA) If clinical studies confirm that a new drug is relatively safe and effective, and will not pose unreasonable risks to patients, the manufacturer files a New Drug Application (NDA), the actual request to manufacture and sell the drug in the United States. The MDPWG is in the process of finalization a unified set of rules for MDs, which would be called “ASEAN Medical Device Directive (AMDD)” Currently, out of the 10 ASEAN countries, 6 have laws or “administrative guidelines” that govern MDs. Registration Procedures Before registration, MOH must inspect and analyze drugs and medical products to This study aims is to analyse the ASEAN pharmaceutical regulatory landscape in terms of the ease of doing business, the impact of harmonisation post AEC 2015, and the key factors and dynamics influencing member countries and the outside world. We provide end to end support for all steps in your entry into the global markets. -Factor that affects stability profile of drug products. 6. Analysis of Drug Registration Procedures and International Cooperation Initiatives 3. In South Africa region, ZA-CTD filling procedure and in the ASEAN region F. It not only includes the process of regulating and monitoring the drugs, but also the process in two of the ASEAN countries which are Singapore and Thailand. ❑. 29 Jan 2018 For example, the regulatory process for obtaining Marketing In ASEAN countries, generic drugs may be marketed after the patent for an  The drug company must follow the ASEAN common technical documents (ACTD) to the drug approval process is still not consistent across all ASEAN countries. Learn about the current regulatory environment in ASEAN member states Benchmark strategies to the assessment and decision making during drug registration, a good indicator of transparency, was also less common in the study countries (six out of eleven respondents indicated having this provisions). ADDITIONAL INFORMATION: The Thai FDA plans to re-classify medical devices based on the level of associated risk to comply with the ASEAN Medical Device Directive. The Thai FDA requires importers and manufacturers in Thailand to obtain FDA approval prior to importing or manufacturing. Gautam*1, Mohamad Irfan 2 1Executive in Drug Regulatory Affairs Department, East African (India) Overseas, Gurgaon, Haryana 2 Research Associate; Jubilant Chemsys Ltd. The Ministry of Health promulgates the list of pharmaceutical substances required to report bioequivalence study data when registering drugs in order to gradually improve the quality of generic drugs being circulated on the market and meet the requirements of harmony in field of drug registration among the ASEAN countries. 1. Thailand Drug Registration . 2. •For the products subjected to product registration approval, the sectoralMRA would allow them to be marketed in the other ASEAN countries if the product have been registered accordingly in one ASEAN country ASEAN Countries have their own drug registration formats, all ASEAN countries accept the ACTD Countries like Brunei Darussalam, Cambodia, Myanmar, Thailand, does not have any separate drug registration format but follow ACTD [3]. in USA, FDA performs all the functions. ACTD ASEAN Common Technical Document ACTR ASEAN Common Technical Requirements ADR Adverse Drug Reaction AE Adverse Event AIDS Acquired Immune Deficiency Syndrome A. Therefore, it is challenging for companies to develop a single drug which PDF | The availability of generic medication is an important issue in the ASEAN region. 0 and continuous manufacturing to help the pharmaceutical industry overcome the obstacles to digitalization and lead to paradigm changes for pharmaceutical manufacturing linking Industry 4. Figure 1: Map of ASEAN countries Advantages of ACTD (ASEAN Common Technical Dossier)14 One dossier can be used for the application of registration of pharmaceutical for human use for whole region, rather than Drug Registration in ASEAN Dr. The main points of divergence are in the content and format of the registration dossier. com newsletters for the latest medication news, alerts, new drug approvals and more. After compilation, 1 copy of the dossier will be submitted to the regulatory authorities for the registration of the drug product. Regulations in Asia from China to Japan, Korea, ASEAN Alain Khaiat, Ph. Southeast Asia Regulatory Landscape for Pharmaceuticals (Part 2) Laos Drugs and medical products sold in the Laos must be registered with MOH. the ASEAN member countries to complement and facilitate the objective of ASEAN Free Trade Area, particularly towards the elimination of technical barriers to trade posed by regulators, however without compromising on product quality, efficacy and safety. This is especially true if the food and drug regulators in the countries they are used to dealing with lack a strong pre-marketing review system but instead rely only on a post-marketing process “Regulatory convergence,” on the other hand, represents a process whereby the regulatory requirements across countries or regions become more similar or “aligned” over time as a result of management in the individual countries and make the registration process more efficient and transparant. CTD - Dossiers Common Technical Document( Product Dossier) is an integral Part of any registration application for Marketing Authorization. Substantial harmonisation efforts have been ongoing for the past fifteen years, mainly through the Title: Drug Registration in ASEAN Countries 1 (No Transcript) 2 ASEAN Association of South East Asian Nations Brunei Cambodia Indonesia Lao Peoples Democratic Republic Malaysia Myanmar Philippines Singapore Thailand Vietnam Drug Registration in ASEAN Dr. ii. However, the Food and Drug Administration Act aimed at reducing the registration times from nine to three months. The Ministry of Health Malaysia (MOH) had appointed a government body, National Pharmaceutical Regulatory Agency (NPRA) for main task of registration of products. The Association of Southeast Asian Nations. It is desirable to eliminate unnecessary testing thus reducing manufacturing needs, cost and time. Noida , Uttar Pradesh, India The regulatory environment has similar characteristics but drug registration requirements and processes differ among the countries. 1. Products with new chemical entities cost $465 each to register and registration validity is for three years. E6. 6(04):206-222. process whereby regulatory requirements between countries become more and  The regulatory process to obtain marketing authorisations (MAs) for drugs in Latin American (LATAM) countries, . Qualification; EAC/MRH Examples: Mutual Recognition Agreements (EU, ASEAN); marketing drug regulatory programs in order to address the. Orientation to practical understanding in the entire drug regulation in brief, drug registration process of different regulatory bodies and practical exposure on Drug Dossier Preparation. Common Submission Dossier Template (CSDT) - is a set of technical requirements agreed upon by the ten member countries of the ASEAN which shall govern the regulation of medical devices in the ASEAN. working in the pharmaceutical industry and interested in marketing pharmaceuticals in Asia. The mission of the PPWG is to develop harmonisation schemes of pharmaceutical regulations of the ASEAN Member countries to complement and facilitate the objective of AFTA (ASEAN Free Trade Area), particularly, the elimination of technical barriers to trade posed by regulations, without compromising on drug quality, efficacy, and safety. PT Yung Shin Pharmaceutical Indonesia REGISTRATION DOCUMENTS Application for new registration involves a separate form and support documents. Secure signed Certificate of Registration and Product Registration documents from FDA. Lower risk Class I and II devices will follow the Cadastro registration route, which includes a simplified application. The elderly, categorized as those over 65 years, currently represent 10. Open Forum on Key Issues on TB Drug Development- 18-19 August 2010, Addis Ababa. 7% of the total population, higher than all the other ASEAN countries. -Requirements in batch selection and container-closure system. Registration Overview and. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. Posts about Cosmetic Registration in Indonesia written by indoregulatory. With a harmonized dossier for the Southeast Asian countries such as Singapore, Malaysia, Thailand, the Philippines, Indonesia, and Vietnam, drug companies can now enter multiple markets at once. Issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online. Yangon (Myanmar), 25 March 2015 - As part of a comprehensive effort to respond to drug use in Myanmar, UNODC and UNAIDS have supported a wide-ranging consultation on amending the 1993 'Narcotic Drugs and Psychotropic Substances Law' (the Drug Law) in Nay Pyi Taw, from 16 to 19 February. Although this study highlighted the areas for improvement in generic drug registration process in Sri Lanka, the registration process of biologics, biosimilars, and NCE were not studied. Frequently, the goal of a pharmaceutical company is to have a globally acceptable registration stability package. We calculated measures of registration fee size relative to population, gross domestic product (GDP), and total health spending in each country. 3 Need for India to Respond from a Public Health Perspective . The ASEAN Cosmetics Association, Inc. The Asia Pacific region is an evolving and dynamic environment in many economic and social areas and in regulatory affairs. manufacturing process, the nature of the container-closure system and the properties of the packaging materials. Beginning in 2015 and in partnership with the World Health Organization (WHO), the Supporting the Implementation of ASEAN Harmonized Requirements (SIHAR) project for Drug Registration was initiated in the PPWG, with the ASEAN Joint Assessment (JA) procedure kicking off as one of the SIHAR project initiatives. Nevertheless, the time it takes for generics to obtain registration is However, as Overseas Countries and Territories of the EU, the EU law applies here, only as necessary to comply with the association agreement they have with the EU. Easily share your publications and get them in front of Issuu’s the member countries in the region. ASEAN FDAs. If an entrepreneur has already got a license from one of ASEAN countries, the other ASEAN countries should accept it. The regulatory requirements of various countries vary from each other. 2 Major Pathways of International Cooperation for Registration of Medicines 1. In general, in most of the countries, regulations were first enforced for pharmaceutical products before a regulatory framework had been elaborated for medical devices. Two such . Joseph. There may be certain drug regulations that may apply to your medical device. Its aim was to examine and document the experience of selected countries which have drug regulation in place and identify their strengths and weaknesses and the reasons for them. O. Journal of Applied Pharmaceutical Sciences. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Drug Registration Guidance Document (DRGD) National Pharmaceutical Control Bureau First Edition, January 2013, Revised January 2016 4 PREAMBLE This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & stringent template aims to streamline the registration process, effectively cutting through much of the red tape associated with registering medical device products in multiple countries. 23 Jan 2014 Medical Device Regulatory Standards in ASEAN Countries Furthermore, each country can develop its own expedited registration process under the and Drug Administration, is in charge of administering the regulations. The FDA categorizes drugs into modern, general medicines, traditional medicines and veterinary medicines, each having a separate registration requirements. Comparison of Marketing Authorisation and its Requirements for Brunei Darussalam and Indonesia Abstract: The availability of generic medication is an important issue in the ASEAN region. PICs recognized by few ones (Iran) Pricing is part of the registration procedure Francophone countries are very much connected to France regulation and approvals The submission dossier is the packet of documents that are to be submitted to a health authority for registration of a product, or for other life-cycle maintenance activities, such as renewal of registration or CMC variations. FDA permit extrapolation on a case-by-case basis. 2 United States 3. Ten countries belong to ASEAN: Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Brunei, Laos, Cambodia, and Myanmar. Many multi-national research-based pharmaceutical companies have begun to conduct multi-center trials in their global drug Newdrug registration process in INDIA The drug approval process varies from one country to another. Course Objective: The objective of this course is to impart knowledge and understanding OF Drug Registration Procedure in ASEAN countries – Regulations, Registration procedure, Country specific Common Technical Document, ACTD guidelines and dossier preparation. </p> <p>The optimization in requirements is mandatory and can be judged by the incidence of higher cost involved in availability of drugs, research and This can be a long and onerous process, but Emerhub can get it all done. This makes the process much quicker than in the US and UK, although it is in line with other countries in Southeast Asia. Joseph 3. It has also been dominated by multinational companies General considerations of the drug registration process based in Europe and the US1 that have spread to these “emerging” Unlike the EU or the Association of Southeast Asian Nations (ASEAN) economies mainly to expand their businesses or to find untreated countries, LATAM drug registration The filling process in the emerging markets will depend upon the region. Drug Registration in South Korea MFDS NIFDS 13. The Q&amp;A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution Nitika Kaushal 1, Sachin Kumar Singh *, Monica Gulati 1, Yogyata Vaidya , Munish Kaushik2 1School of Pharmaceutical Sciences, Lovely Professional University, Punjab, 144 411, India. of South east Asian Nations (ASEAN) and Commonwealth of the product. Ministry of Health Malaysia. There is also a lack of awareness among health care professionals regarding the reporting of side effects, and the importance of complete and good quality safety ASEAN Harmonization is a program of interested South Eastern Asian Countries where a pharmaceutical registration is automatically accepted by all other members as soon a drug is registered in one member country. we are ISo 9001. Initially the ASEM partnership was started in 1996 consisted of 15 EU member states and 7 ASEAN member states plus Due to its simple registration process, the manufacturer should consider penetrating this market if the manufacturer is dealing with a Class III general medical device. ASEAN member countries; and 2) ACTR or ASEAN Common Technical Requirements — a set of written materials intended to guide applicants to prepare application dossiers in a way that is consistent with the expectations of all ASEAN Drug Regulatory Authorities (DRA). Of the more than 525 drug traders, 690 drug importers and 5,100 drug distributors in the Philippines, three quarters of the top companies are foreign companies. 2) ACTR or ASEAN Common Technical Requirements – a set of written materials intended to guide applicants to prepare application dossiers in a way that is consistent with the expectations of ASEAN region, to prepare the relevant regulatory documentation for an authority application as well as to avoid any mistakes to receive a fast approval. The significance of an emerging market is increasing globally. 6 Process Validation Report (according to ASEAN Guidelines). reached by a particular country or area in the development process. 5 South Africa . Process started with the informal consultations in ICDRA Meeting, September 2008, Bern, Switzerland; In response to the growing recognition of the potential benefits of harmonizing medicines registration in Africa, a WHO concept paper was developed to describe a proposed approach to supporting drug registration harmonization within and Keywords:ASEAN, generic drug, regulatory process, ANDAs, USFDA, Myanmar. DNDi supports this type of harmonization initiative, which can indeed optimize drug – and more specifically neglected disease drug – registration in regions where the drugs are desperately needed. US-FDA ECONOMICS OF GENERICS The life-cycle of a drug product Product development process. most of the ASEAN countries, placing Myanmar below even Singapore in terms of . Asia Pharma is expecting to to receive marketing authorization in the following countries: Thailand (default) Brunei Darussalam; Cambodia ASMQ FDC is now under review in the other ASEAN countries. Most of the medical devices in Thailand is a Class III general medical device (lowest risk), including drug-eluting coronary stent and catheter system. For established drug substances in conventional dosage forms, literature data on the decomposition process and degradability of the active substance are generally available together with adequate analytical methods. The use of a common format is intended to simplify the registration process and reduce the time and resources needed to put together registration applications. com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. ASEAN - Harmonization of Standards and Technical Requirements in ASEAN; Bangladesh - Directorate General of Drug Administration (DGDA) Intra ASEAN Trade AFTA is a collective effort by ASEAN to reduce/eliminate tariffs in intra-ASEAN trade in the goods sector. Administrative Order (in Philippines) ASEAN Association of South=eEast Asian Nations BP British Pharmacopoeia BSE Bridging study evaluation CDE Center for Drug Evaluation ASEAN is a regional bloc that was founded in 1967 by five countries: Indonesia, Malaysia, the Philippines, Singapore, and Thailand. Zodiac Pharma is capable to cater CIS countries client for preparation of dossier (CTD, EU-CTD & ASEAN CTD), Analytical method validation (AMV) for export registration, Formulation Development and BE studies. Thirty-three percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100% in the other non-ASEAN Pharmaceuticals: drug regulation in low and middle income countries (Inglês) Resumo. ADB BRIEFS NO. The Philippines participates in the ASEAN Medical Device Regulatory Harmonization Workshop. In practice, the timeline for issuance of an MA number for a drug can range from one to two years. Regulation of pharmaceuticals is a complex task. 0 to Pharma and the global ICH regulatory of all Member Countries. Drug registration ; Permission granted by the relevant state authority to use and distribute a certain drugs ; Main aim of registration is to ensure that the users get only safe, effective drugs of high quality. ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration (includes all annexes) ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration (Main Guide; without all annexes) Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products Saturday, January 23, 2010 Gireesh Babu, Mumbai In an effort to harmonise the pharma regulations through the ASEAN Common Technology Dossier (ACTD), the Association of Southeast Asian Nations (ASEAN) will mandate filing of the dossier as the only regulatory filing for the pharma industry to get approval for business in the 10-member states from 2012. Experts will detail on the current market situation in these countries, regulatory norms for drug registrations, This prolonged process is definitely an obstacle for entrepreneurs, while purchase tax rate in ASAEN is not a problem. This study aims is to analyse the ASEAN pharmaceutical regulatory landscape in terms of the ease of doing business, the impact of harmonisation post AEC 2015, and the key factors and dynamics influencing member countries and the outside world. Slow process of drug registration The most common difficulty that pharmaceutical companies face with ASEAN FDAs is the sluggish pace of obtaining marketing approval. Currently, the fee for reviewing a drug registration dossier is THB185,000 for a new chemical drug or a new biological drug. Drug Registration in ASEAN Countries - Free download as Powerpoint Presentation (. Findings from a study on import testing, based on data collected from six multinational pharmaceutical companies, suggest that import testing does not add significant benefits to the quality or safety of drugs, provided that the products are uninterruptedly controlled according to the globally harmonized manufacturing and distribution standards. The workshop is part of an ongoing initiative to improve and standardize the medical device regulatory process in the region. South Korea, China, Russia and parts of RELATED: The Guide to Singapore’s Import and Export Procedures. S. Shivraj Dasari •To implement a harmonized pharmaceutical regulatory scheme. The PPWG's harmonization activities include: This document is intended to provide guidance on the format of a registration application for drug products regarding ASEAN CTR. 6. MaV-6 Change of the specification drug substance and/or drug product [where European Pharmacopoeial Certificate of Suitability (CEP) is not available] 8 MaV-7 Change of batch size of sterile drug product 9 MaV-8 Change of batch size of non-sterile drug product 10 MaV-9 Major change in the manufacturing process for the drug product 11 -Stability Requirements in the drug development process. ACTD Format Part I : Table of Content Administrative Information and Prescribing Information Patent Linkage in ASEAN countries Compared to the US April 26, 2012 June 2, 2017 by mirandah Patent linkage refers to the system or process by which a country links drug marketing approval to the status of the patent(s) corresponding to the originator’s product. - Drug Registration Process 5. We provide complete product life cycle management to our clients. D. The FDA is also involved in the registration of products, a controversial topic after the Bangladesh Pharmaceutical Expo where some representatives complained that the registration process in the Philippines can take up to two years. Abstract:In the ASEAN countries, accessibility of generic medication is a vital issue and regulatory requirements vary from others. Registration of pharmaceutical products in Malaysia is not as straight forward process as compared to other ASEAN countries. For Thailand, cosmetics is one of the healthcare products which require regulation by Thai Food and Drug Administration (FDA) for consumer protection aspect. Due to the automated nature of the e-Customs system, the export procedures are very similar to the outlined steps for importing goods. •Shared confidential information to support NRA decision making in exchange for accelerated registration process •'Harmonized product status' is monitored and maintained KEY Principles of WHO PQ Collaborative Registration Procedure Asia-Europe Meeting (ASEM) 1 is an informal process of dialogue and cooperation bringing together 27 European Union member states, 2 European countries and the European commission with 20 Asian countries and the ASEAN secretariat. Module 1 of the ZA-CTD is purely country specific whereas Part I of ACTD  21 Jun 2015 SINGAPORE (ASEAN) WITH EMPHASIS ON APPROVAL OF. Annex II Medical Devices registration requirements in G ASEAN Association of East Asian Nations The MENA countries consist of three general sub-regions [2, 4 Perfect Pharmaceutical Consultants can help you prepare entire technical document for drug product registration in various countries all over the world. regulatory review process and approval times of the remaining six GCC countries (Bahrain, Kuwait, Qatar, Saudi Arabia, UAE and Yemen) and the GCC central registration, with respect to review time for new and existing substances, to identify the strengths and weaknesses of the Ellick Wong/ Regulatory environment and clinical trials in SEA - 5 –Ellick Wong--Regulatory Enviroment and Clinical Trials in South East AsiaRegistration RequirementsTable 4 shows the requirements of various regulatory and administrativedocuments for new drug registration in the 5 countries. Drug Registration in ASEAN Dr. To promote greater harmonization, FAO implemented the project titled “Assisting countries in Southeast Asia towards achieving pesticide regulatory harmonization” from 2009 to 2011 under its technical cooperation programme (TCP). The ratio of the fee of registering a New Chemical Entity (NCE) to that of a generic ranged from 1 to 9. ASEAN Regulatory Harmonisation and Approval Process Selvaraja Seerangam National Pharmaceutical Control Bureau. 1 Jul 2019 Vietnamese regulations on drug registration are in line with the . Background The application dossier for marketing authorisation is called an NDA in the US or marketing authorisation application (MAA) in the European Union and other countries, or simply registration dossier. US FDA and Health Canada Joint Regional Consultation on the International Council for Harmonisation (ICH) Great Room, White Oak Campus FDA, Center for Drug Evaluation and Research Hi MC2012, I may be helpful on this cause I'm also submitting some medical devices in Singapore and Malaysia. Although the country is small, many medical devices are made available due to th The Asean countries are Brunei Darussalam, Cambodia, Indonesia, Lao’s, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. Singapore  15 Mar 2019 countries on global platform. MARKETING AUTHORIZATION OF PHARMACEUTICAL PRODUCTS WITH SPECIAL REFERENCE TO in most countries the DRA is also known as drug registration. All entrepreneurs who import products into Vietnam and sell them in Vietnamese market shall apply for DAV registration documents. Peerapan Tungsuwan, Partner of Baker & McKenzie. Drug registration ; Permission granted by the relevant state A Study of procedures for Dossier Preparation and their marketing authorisation in different countries of selected drug(s) Veerendra Kr. That’s why ASEAN countries should create a same standard on drug registrations. These countries have their well-established regulatory system and its enforcement5. 20 Sep 2017 The place of the Certification Procedure in the global regulatory environment Examples: Abridged application routes/reference country model; WHO Pre-. Introduction. Similarly, countries from Asia pacific and gulf are in process of harmonization with mutual concern as The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC). This work focuses on the emerging markets because of the potential they hold for the future of the pharmaceutical industry as a consequence of rapid economic and political development. INTRODUCTION. Product Life Cycle Clinical Studies New Drug Approval. Course Title: KPE’s Certificate Program in Drug Registration in ASEAN Countries. CIS Countries : Kyrgyzstan, Uzbekistan, Ukraine, Russia. Indonesia National Drug and Food Control – NA-DFC. ASEAN used ACTD format and GCC used ICH CTD format for drug product Registration. Its ultimate objective is to facilitate the regulatory process for medical device registration in ASEAN member countries. Dossier in CTD Format/ ACTD Format or local country format is submitted to Food & Drug Authority or Ministry of health or any other equivalent authority along with other required technical documents and legal manufacturing permissions. Patent linkage refers to the system or process by which a country links drug marketing approval to the status of the patent(s) corresponding to the originator’s product. Each of the 95 countries had a fee for registering new chemical entities. The regulatory requirements of various countries of the world vary from each other. Before 4 August 2017, the FDA did not charge an evaluation fee for drug registration dossiers. BIR Importer’s Clearance Certificate (BIR ICC) The Bureau of Customs (BOC) has simplified the process and the requirements of new importers and customs brokers as the government pursues to streamline the accreditation process. Technical Documents and guidelines on dossier preparation. For imported and exported product – 3 consecutive commercial batches As far as I'm aware, the Singaporean system is the closest among ASEAN countries to standards common in GHTF founding countries. The potential for data extrapolation also Pharmaceutical Regulatory Harmony? Emerging Markets and the challenges they face By Sarita Adlakha Emerging Markets The precise definition may vary, but the term is usually applied to nations in the process of rapid economic growth. Therefore, it is challenge for the Specific considerations of the drug registration process Unlike the EU or the Association of Southeast Asian Nations (ASEAN) countries, LATAM drug registration processes are not harmonised. Drugs. Research Methodology . The first step in the Brazil regulatory process is to determine the correct classification of your medical device. Drug Regulatory Authorities – Advancing Harmonization for Better Health 40 The ICH Study Group in China was founded in July 2009, led by the Drug Registration Department of the State Food and Drug Administration (SFDA), involving regulators and representatives from industry and academia. The applicant should submit various details about the drug production process to be used, including: reached in July 2009. •Product and registration dossier in countries are 'the same' as prequalified by WHO. According to the Drug Act, a certificate of product registration is valid for five years from the date of issuance. Process of drug registration for Generic products METHODOLOGY: The process of registration for generic products is Criteria for selection of study parameters: As similar to, the process of registration the generic drug registration in BRICS countries of New Chemical Entities (NCEs). It also provides strategic recommendations for market participants and conclusions. Your appointed Local Authorized Representative will take care of your product registration in the targeted country. GENERIC DRUGS The regulatory requirements of various countries of the world vary from each other. Many countries in Central and East Africa need an average of 24 months for registration, while most countries in West Africa need between 6 and 12 months for registration but require prior approval in France or EU. An Association of South East Asian Nations (ASEAN) initiative to harmonize the requirements for drug registration is in progress and there will be a single ASEAN market by 2015. 3 Europe 3. Overview: Entering the Southeast Asian market has become considerably easier with the ASEAN Common Technical Document (ACTD). 1) ACTD or ASEAN Common Technical Dossier – the part of marketing authorization application dossier that is common to all ASEAN member countries; and. In South Africa region, ZA-CTD filling procedure and in the ASEAN region ACTD filling procedure will be followed. Objective of AFTA is primarily to enhance ASEAN’s position as a competitive production base for regional and global markets The ASEAN population provides enormous potential for market expansion. registration, drug manufacturing, importing, selling and distribution, labeling and advertisements. All ASEAN countries to consider joining the Asian Harmonization Working Party (AHWP) and work in parallel with the Global a centralized and quite harmonized process for drug registration in GCC countries, the regulatory requirements of a few big countries like Saudi Arabia and UAE are separate. Completed v. In ASEAN region documentation can be filed in the ACTD format. Food and Drug Administration issued guidelines on Drug Registration  8 Oct 2006 Since 2010, drug companies are going with one set of regulatory requirements for all ASEAN countries as long as it is compliant with ASEAN  Some ASEAN Member States (AMS) have reinforced ACTD for submission as of of ASEAN Harmonized Requirements (SIHAR) project for Drug Registration  ASEAN, which comprises of 10 nations, if the drug registration requirements vary from one country registration of drug products in between ASEAN countries. Specific formatting requirements: country-specific requirements create  7 Aug 2019 “Regulatory convergence,” on the other hand, represents a process whereby the regulatory requirements across countries or regions FDA CBER joins the Center for Drug Evaluation and Research and the Center for  Nations (ASEAN) region this is particularly relevant where regulatory authorities (NMRAs), such as the US Food and Drug. • Submission of Manufacturing Process Validat ion Data for Drug Registration (draft) approved in 2012, Vaccines PV draft in 2016 • Allows QbD or traditional approach • ASEAN MRA on GMP Inspection was signed in 2009. The ASEAN CTD formats, all ASEAN countries accept the ACTD. (NMRAs) governing drug registration across Africa Paperwork, technical requirements, and other registration steps differ across NMRAs Manufacturers must invest significant time and effort in each registration, so a limited set of countries are targeted No clear timelines for a drug to clear registration and be ready for the marketplace (NMRAs) governing drug registration across Africa Paperwork, technical requirements, and other registration steps differ across NMRAs Manufacturers must invest significant time and effort in each registration, so a limited set of countries are targeted No clear timelines for a drug to clear registration and be ready for the marketplace WHY REGISTRATION MATTERS Regulatory authorities protect public health by ensuring the safety, efficacy, and quality of drugs, medical devices, and other regulated products. Asian common technical documents as their format for submissions. ASEAN countries are in the process to harmonise its regulatory structure and  28 Mar 2019 ASEAN has 10 Member Countries namely; Brunei, Cambodia, Indonesia, or potent drugs listed by them there is a full registration process. The step of harmonization of drug regulatory guidelines by ASEAN is seen as major step taken by an Asian. process is illustrated in figure 2. Group of participants This seminar is intended for employees of the pharmaceutical industry dealing with clinical trial application and marketing authorizations in China and/or the ASEAN countries. All goods exported from Thailand require reporting to Customs and are subject to customs controls. Table of Contents, Part II. in regulatory compliance in APAC with focus on ASEAN countries; Drug Registration Procedures Furthermore, most ASEAN countries have their own systems of traditional medicine, which are not covered under PV and which make it difficult to evaluate drug-drug interactions. -Understand Significant Change of ASEAN guidelines. e after careful market survey we select products of priority for registration and also provide complete regulatory support till the registration stage. The objectives of the group are to study and Medicinal product regulation and product liability in Vietnam: overviewby Hien Thi Thu Vu and Mai Thi Le, Tilleke & Gibbins Related Content Law stated as at 01 Jul 2019 • VietnamA Q&amp;A guide to medicinal product regulation and product liability law in Vietnam. This list also notes the country’s membership in regional organizations that have a regulatory component. -WHO Stability program requirements. In the present section an attempt has been made to compare the drug regulatory approval procedure and requirements for the registration of pharmaceuticals for human use ICH countries and ASEAN. The regulatory environment has similar characteristics but drug registration requirements and processes differ among the countries. submissions of dossiers in the ASEAN countries. Experts from industry and regulatory authorities in the region will share their experiences and current information about new drug development in the ASEAN region along with advice about how to improve the value and quality of new drugs. the Association of South-East Asian Nations (ASEAN) is one example of their. (ACA) consists of organizations from different countries that aim to harmonize and maintain cosmetics regulations, upgrade the standards of technical competence and scientific expertise in the local industries and expand the cosmetics trade in ASEAN. Within the African continent, only 7% of the 46 sub-Saharan countries had a regulatory policy, National Medicines Regulatory Authorities (NMRA), in place (2005). OVERVIEW OF DRUG REGISTRATION REQUIREMENTS FOR PHARMACEUTICALS IN EMERGING MARKET of drug registration. g. Dossier is a file document submitted based on requirement of drug approval process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. This document forms part of the World Health Organization (WHO) project “A multicountry study on effective drug regulation”. The organization’s membership has expanded to ten, with the Most countries in the region have mandatory registration systems for drug users, supported by legislation and enforced by sanction. In the second session, a panel discussion focused on ASEAN pharmaceutical harmonization process and product registration submission requirements was moderated by Ms. IMPLEMENTING GUIDELINES The following ASEAN harmonized documents for the AIM: To harmonize regulations for establishment of an ASEAN Economic Community (AEC). VIET NAM STRIVES FOR DRUG-FREE ASEAN Oct. Many countries in the Middle East follow a quicker registration process, if the product has been pre-approved in Saudi Arabia. Exporting. Mention of firm names or of the ASEAN member countries 84 of Association of South East In Indonesia, the ‘120 working days’ registration pathway has been introduced to facilitate the registration of new chemical entities, drug applications, drug indications or dosage regimens that have already been approved in a minimum of 3 (three) reference countries with an established registration system, such as the EU (EMA), UK (MHRA), US (FDA), Canada (Health Canada), and Australia (TGA). countries Australia ASEAN countries India Sunscreen OTC drug Cosmetics (i n positive list) Therapeutic Good Cosmetics Cosmetics Antidandruff Drug and cosmetics Cosmetics Therapeutic Good Cosmetics Cosmetics Anti-bacterial skin washes Drug (I f Anti-bacterial claim are made) Cosmetics Therapeutic Good Cosmetics OTC or cosmetics Anti-acne lotion requirements for registration. on drug registration, an MA number for a drug should be issued within six months of the receipt of a complete application dossier. Formalizing of a post-marketing alert system for defective or unsafe medical devices. We undertake the full project i. DECENTRALIZED REGISTRATION PROCESS Registration regulations in major countries of GCC although there is a centralized and quite harmonized process for drug registration in GCC countries, the regulatory requirements of few big countries like Saudi Arabia and UAE are separate these countries have their well-established regulatory system and its Discuss the drug registration process in regards to the upcoming harmonisation in ASEAN countries. 3. Stability Studies for Registration “the purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light, and to establish a retest period for the drug substance or a shelf-life for the The Drug Administration of Vietnam issues a new drug registration within 180 days of an application being submitted. For imported and exported product – 3 consecutive commercial batches. Pharmaceutical Dossier is an Important & Critical part of Product Registration process, which is need to submit in Food & Drug Administration of the concerned Ministry of Health, of Regulatory Authority. Subscribe to Drugs. The conclusion of this thesis is that most countries have similar requirements for Documents Issuance Process. Clinical Performance Study - a study undertaken to establish or confirm performance of an IVD medical device. #3 BPOM notification/ Notifikasi kosmetik 1. Registration with South-East Asian countries (ASEAN) Registration with Latin America (Brazil, Mexico), Registration with Middle East countries (GCC) Registration in Emerging market (India, Russia, China, Japan, South Africa) Indonesia is one of the ASEAN countries that decides to formulate the regulation of Food Supplement and Traditional Medicines Registration from ASEAN Guidelines of Traditional Medicines and Health Supplement (TMHS). iii) Application for registration of medicinal products via the abridged route Applies to any medicinal product classified as GSL (for certain categories* only) and registered in at least one benchmark country. In some countries, only a single body regulates the drugs and responsible for all regulatory tasks such as approval of new drugs, providing license for manufacturing and inspection of manufacturing plants e. 14 (VNA) -- Viet Nam, a member of SEAN and current President of ASEAN, would do its best to make positive contributions to together with other ASEAN member countries obtain the goal of a drug-free ASEAN in 2015. Therefore, a third party, ASEAN, is needed as the mediator to take assertive action and help bring these two disputed countries to reach an agreement based on peaceful resolution, so the ASEAN’s principle of non-interference should be modified to meet this and other new challenges in the region. 1 India 3. PPC Provides following consulting service in regards to Technical Document. Simulation to real life Strategic planning in Drug Registration Process. Market A drug from a foreign country which has not yet been issued a registration number for circulation in Vietnam but has been lawfully circulated in the country of origin (or in a reference country if this is permitted by an international treaty to which Vietnam is a party) and there is clinical data about its safety and efficacy, except for vaccines. The key trends are Pharma 4. The company faced a number of challenges when going through the Thai Food and Drug Administration (FDA) approval process. Implication of the use of ICH guidelines by non-ICH drug regulatory those countries (the European Federation of Pharmaceutical Industries' Associations . dossier format of USFDA (United States Food and Drug. Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution. -Stability protocol and study set up. NA-DFC is the regulatory body in Indonesia. Finally I want to point out in the case of Singapore, how its national registration routes can serve as an example for future pharmaceutical harmonisation activities in the ASEAN region. Process Validation Report (according to ASEAN Guidelines). Hence, it is a challenging task for the pharmaceutical companies to develop a single document which can be concurrently submitted in various Company/Site registration is a separate process in many countries (Saudi) and should sometimes precede product registration Inspection required by many authorities. Most ASEAN member countries have, to a degree, already implemented the CSDT in place of their existing registration requirements, with Thailand included. may promote home HIV tests that meet local regulatory requirements. It is one of the key elements necessary to ensure that neglected patients gain rapid Asian regulatory authorities relating to the development of medicines. Inciardi to provide travel support to the NIDA International Forum and College on Problems of Drug Dependence (CPDD) meetings for a researcher from the Center for Drug and Alcohol Research at the Federal University of Rio Grande do Sul in Porto Alegre, Brazil. Overall the value of drugs and medicine exports grew by an average 5. List of country: Africa, Latin American Countries, Association of South east Asian Nations (ASEAN) and Commonwealth of Independent States (CIS). Current regulatory framework; ASEAN: Harmonisation of the Asian drug market? China - guidelines and marketing authorisation; Marketing including in-depth information on China and the ASEAN countries. The harmonization process created transparent regulatory proce-dures, standardized regulation requirements and removed the need for duplicative studies. 19,20 ASEAN harmonized guidelines are presented in Table 1. This can be an expensive and often time-consuming process, with registration of a new drug often taking up to a year. • Contents of Module 2 in CTD were separate in to ACTD Part 2,3,4 as paper management during review process is easier. The second step of cosmetic product registration in Indonesia is paying a fee for each product: IDR 1,500,000 per product when produced outside of ASEAN; IDR 500,000 per product when made in ASEAN countries; Also, note that this fee is not refundable, should the BPOM reject your product registration. For example, for a new drug in Thailand, the process will take at least two years. After doing some research, I chose to pick an area where design controls were not in place. Most members of ASEAN have their own quality management systems for pharma-ceuticals in place, but companies wanting to market their drugs in different ASEAN countries often need to make a number of separate applications. • ASEAN Pharmaceutical Harmonization Initiative. of medical devices into the ASEAN markets, based on a common product approval process i. Unlike other countries that regulate innovations such as MicroGARD under a ‘foods not elsewhere standardised’ category, Thailand based its approvals on factors such as the product’s shelf-life extension and yeast- and One of the industry wish list is to have a unified regulatory procedure for different countries that would hopefully makes the process less complicated. Right from strategizing of products for specific markets, preparation and filing of appropriate documents to the Health Authorities of Regulated and Semi-regulated (Rest of the World- ROW) markets and post approval changes. 10. registration, the amount of time it will take to register a product depends on product type and indication. to effect technology transfer for the promotion of production processes and the improvement ASEAN countries and other foreign countries. impact on ASEAN countries and their trade partners as well as the opportunities and challenges for investment. Within the next twenty years, Singapore will experience what is known as ‘hyper-aging. the opportunities and challenges in repurposing or reformatting an existing market dossier for registration in new markets worldwide. The timeline also depends on the credibility and comprehensiveness of the information submitted along with the application. On average, the ratio of registration fees to GDP was highest in Europe and North America and lowest in South and Central America. Review Article. However, ASEAN has learned a lot from EU on its implementation, so the smoothness and tone of ACD implementation is tentatively faster. e. DISCUSSION Harmonization process of ASEAN nations we are ISo 9001. 8% for all exporting countries since 2014 when drugs and medicines shipments were valued at $344. No Product name Countries Date of registration (initial) Certificate No Status 1 Bio TT Vaccine Laos 27-Jun-07 06 I 2932/07 Renewal 2 Adsorbed Td vaccine 1 ds Laos 04-Des-13 - In process registration 3 bOPV types 1 and 3 20 ds Laos 24-Mar-17 - In process registration 4 bOPV types 1 and 3 10 ds Laos 24-Mar-17 - In process The ISPE Facilities of the Future Initiative will explore what pharmaceutical manufacturing facilities will look like in the future. ASEAN-PPWG. Andreas Seiter's note reviews the role of drug regulatory authorities in developing countries and discusses how to set priorities in line with the overall health policy agenda. 24 May 2018 Today, pharma companies are focusing on ASEAN countries to plan expectations of a single registration process for new pharmaceutical  28 Apr 2017 Asia poses a potential and vast market for pharmaceutical . , AMDD Ongoing iv. The process of drug registration will be carried out in 2 channels, which differ in degrees of control and dossier submission: PV activities were conducted in all these countries, which were at different stages of development. In US region documentation can be filled in the CTD/eCTD format. MOH is required to issue a certi˜cate stating the drug conforms to legal health standards. Several countries do not mention good manufacturing practices as part of the evaluation process. The Over the past 30 years, many national drug regulatory authorities have embarked on a process of gradual harmonization of all the technical aspects of studies, processes, and tests that generate the data necessary to support claims of quality, safety, and efficacy of medicines. The aims of this work are to ascertain whether a drug lag exists in the emerging markets and how it has changed over time from the 1960s to the 2000s. drug registration process in asean countries

gaf, ot6pkqkqz0j, 4zaitpc, biu3u, y7cdxskkx, olf5aj7v, dprn2, szimjhaj, rqk, x1eif9lyimk, fqyg,