Pharmaceutical Products Registration Requirements for ASEAN and GCC Countries

Abstract

Registration of pharmaceutical products is a challenge and an important task in regulated, semi regulated as well as rest of the world countries. Although the requirements are harmonized in regulated countries by Common Technical Document (CTD) filing, yet others have enormous diversity in requirements. The purpose of the present study is to understand the requirements for registration of drug products in countries like the Association of South East Asian Nation (ASEAN) and Gulf Cooperation Council (GCC).In the ASEAN and GCC region, A-CTD filling procedure and CTD format is used, respectively. The optimization in requirements is mandatory and can be judged by the incidence of higher cost involved in the availability of drugs, research and development facilities. For better treatment, safety and efficacy the drugs must be justified and rationalized for public security. The study also provides the challenges and barriers faced by the emerging markets (ASEAN). The commercial significance of markets is increasing globally. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and ensure their place in the market.

Keywords: CTD, ACTD, ASEAN, GCC