REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND

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.