REGULATORY REQUIREMENTS FOR THE REGISTRATION OF GENERIC SOLID ORALS IN USA, SINGAPORE, MALAYSIA, AND THAILAND

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 challenging for the companies to develop a single drug which can be simultaneously submitted in various countries for approval. The role of regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation 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 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. Regulatory requirements and generic drug registration for USA and ASEAN regions is made at the end of the section. In ASEAN region documentation can be filed in the ACTD format. In US region documentation can be filled in the CTD/eCTD format.