Marketing Authorization Requirements for Generic Products in African Countries and Comparison with US market

Abstract

As the market for pharmaceuticals industry is rapidly growing this is because of advancement technology related to formulation. It has been seen that as such there is increase in market authorization given by specific nation regulatory authority. Likewise, there is market authorizations for African countries where the documents need to be compiled and submit in CTD format only. As the countries of such continent has not been so much stringent as like US or EU. There are many cases where the difference in prior submission to final approval can be seen. Though these countries are the developing countries it has been seen that there are guidelines which need to be followed for registration of medicines for that specific nations. For generics there is not much specific requirements which can be vary as from that novel drugs. The fees, document filing, approval, validity, label requirements are some of the differences to be note down for registration. The US market is more reliable as compared to Africans nations. The final approval decision relies on the regulatory authority. E CTD is mainly the requirement for US market. The DMF is the general requirement for any country. The African countries need to amend the guidelines and laws. Majorly there is much need to work on the areas concerned with the safety and efficacy of the medicinal products.