REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND
Journal Title: International Journal of Drug Regulatory Affairs - Year 2015, Vol 3, Issue 1
Abstract
The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug registration requirements and processes differ among the countries. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. In ASEAN region, documentation can be filed in the ACTD format. Even though ACTD format is mandatory from 2009, the member countries have their own requirements for registration process like administrative documents, labeling. The purpose of this paper is to give a comparative overview on the Drug regulatory requirement for generics in two of the ASEAN countries which are Singapore and Thailand.
Authors and Affiliations
Achin Jain, Venkatesh M P, Raja Mohan Reddy. G, Pramod Kumar T M
Keywords
Related Articles
- EP ID EP338379
- DOI -
- Views 109
- Downloads 0
Simultaneous estimation of xanthine alkaloids (Theophylline, Theobromine and Caffeine) by High-Performance Liquid Chromatography
Methylxanthines are mainly a group of phytochemicals which are derived from purine base xanthine. These xanthines are obtained from plant as a result of secondary metabolism. There are various physiological actions that...
Drug approval process in India and Europe
Every time a new drug is developed it requires a great amount of research work in manufacturing, Pre- clinical Science, Controls, Chemistry & Clinical trials. Regulatory agencies have Drug Reviewers who has the responsib...
HARMONIZATION & ADVANCEMENT IN PHARMACEUTICAL INDUSTRY
The urgent requirement to rationalize and harmonize regulation was impelled by instance of rising cost of Health care, Research and Development and need to meet the public requirement to approach for the safe and efficac...
Understanding the globally harmonized system of classification and Labeling of Chemicals-The Purple Book
Global Harmonized System (GHS), relating to hazard chemicals, is a process of making a regulation among countries uniform to the extent possible so as to benefit an industry to export its products to several countries wi...
PROBIOTIC FUNCTIONAL FOOD VS DRUGS: IMPACT OF INDIAN REGULATORY STATUS ON DESIGN OF QUALITY CONTROL GUIDLINES FOR PROBIOTICS
Probiotic now a day's generally utilized all around the globe because of headway as a part of the relationship in the middle of nourishment and wellbeing other than their promising helpful advantages and irrelevant react...