Regulatory Account on Drug Registration Requirements For Generic Drug Product in Africa Asen & Latam Region

Abstract

India is the one of two largest exporters of drug products all over the world. Thus, Indian applicant need to be prepared for the format and data requirements for market approval. India exported US$ 17.27 billion of pharmaceutical products all over the world in 2017-18 of which 20% of drugs are supplied to the ROW countries. Rest of the World (ROW) countries consist of countries belonging to Middle East, Latin America, CIS, Asian & African regions where the regulations for drug products are semi regulated and the regulations are still improving. These countries have their own regulation to specific requirements for obtaining a marketing approval. However, some countries follow ICH CTD or ACTD when evaluating the applications. The differences in the regulations of these countries, sometimes, create ambiguity while compiling a dossier to get the register their drugs. Thus, this thesis attempts to highlight the common requirements of African, ASEAN & LATAM countries and also differentiate them for better understanding of requirements & assist the sponsor for filing the dossier in as many countries concurrently.