Regulatory Requirements For Registration of Drug Products in African Market

Abstract

In response to national regulatory challenges in Africa, a number of regional harmonisation efforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the AU Model Law on Medical Products Regulation. The AMRH initiative is the initiative which serves as the foundation for the formation of AMA – African Medicines Agency. The AMA coordinates and implements regional systems of harmonization which are authorized by AU Model Law. Africa is a mainland covering fifty five member states considered as counties with 1.2 billion population and expected to grow the pharmaceutical business at around 12% CAGR. African people are suffering for vulnerable disease and have a second largest medicine demand in the world with around 30 % self-sufficiency and 70% dependency on external drug market thru import. Indian pharma sector having opportunity for such market potential due to low cost, volume, quality manufacturing. The objective of study in this work is procedure for drug registration filing and post approval variation filing for five counties of continent to facilitate sponsor for simultaneous filing and variation compliance and ease of regulatory compliance with low cost handling. Thus knowledge of guideline specific for individual country becomes important to determine the most stringent member, which shall ease approval process in other target counties in the region. Pharmaceutical companies operating in African markets are experiencing difficulties in complying with the technical requirements of individual African country. The conditions of registration of a medicine are therefore considered dynamic taking into account that variations to the original registered dossier may become necessary during the lifetime of the medicine. Procedures for the implementation of the different variations are presented here to assist applicants and Sponsor. Once the medicinal product is registered for the sale in above five African counties, any variations to the drug product (including original information submitted with the application) have to be submitted to the regulatory authority for the approval. Changes or variations to the details of a drug may be made in order to modify or improve the medicinal product, to introduce additional protection based on new scientific knowledge, or to meet required market demands.