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THE PHARMA REVIEW (MARCH - APRIL 2018)

Comparing Key Registration Requirements of Generic Drugs in East Africa, West Africa, USA & Europe with Main Focus on Kenya

Monika A. Patel1, Mrunali R. Patel*1, Rashmin B. Patel1

Introduction: Pharmaceutical Regulatory Affairs (PRA) is a consequential unit in a pharmaceutical company that prosperously drives the Research and Development (R&D) endeavor of the company to the market. Each nation has its own regulatory authority who is responsible for the rules and regulations and guidelines namely, Food and Drug Administration (FDA) - USA, European Medicines Agency (EMA) - Europe, Pharmacy and Poisons Board (PPB) - Kenya, National Agency for Food and Drug Administration and Control (NAFDAC) - Nigeria. Africa is the second largest and most populous continent of the world and African people suffer from numerous diseases. The objective of this study is to investigate in various parameters required for registration of drug product to country- specific Kenya (West Africa). Also, a comparative study is done which might help the sponsor to file the Dossier in many countries. This comparison of the registration procedure is useful to the new producer to globalize their business in the worry countries. 

 

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