Regulatory Requirements and Comparative Study For Registration of Corticosteriods Drug Products In Asean and GCC Market

Abstract

The product registration regulation in ROW countries is a challenging task because they are not harmonized. ASEAN and GCC regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. ASEAN uses ACTD format and GCC used ICH CTD format for drug product Registration. The thesis work emphasizes on a comparative approach for registration process of corticosteroid in Singapore, Malasiya, UAE and Saudi Arabia. But availability of these products in the market is not as easy as it seems to be. In India, there are numbers of Pharmaceutical manufactured, imported and exported to foreign countries under the guidance of the regulating authority. Certain guidelines has to be followed by the manufacturers or the company owners to provide a safe, effective and good quality products to the consumers in the market. Regarding the ASEAN and GCC region, each region has its own specific guidelines, compliances for the registration of Pharmaceutical product. Also there are similarities and disimilarities in the registration process of Pharmaceutical product. Each countries have its own terms and definition of Pharmaceutical product. There are various registration procedures having certain registration fees which is submitted to the agency for approval. The manufacturer needs to follows the specification and proper labelling guidelines criterias provided by the regulating authority of respective region.