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THE PHARMA REVIEW (MAY JUNE 2019)

A Comparative Approach of Current Regulatory Requirements for Approval of Generic Drugs in Emerging Markets of China and Brazil

Sai Sree Nimma1, Lakshmi Prasanthi Nori*2 & Ramarao Nadendla

Introduction: The regulatory requirement for the approval of generic drugs varies from country to country. The role of regulatory authority is to ensure the quality, safety and efficacy of all medicines in circulation in their country. The authority not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution and promotion of it. Generic drug registration is a very strenuous and complicated process in many countries due to the differences in registration process, which substantially impact on the success of its multidisciplinary submissions strategy. Therefore, an appropriate submission strategy makes a smooth review process without any significant delays or failures. This review focuses on the registration requirements of generic drugs i.e. Abbreviated New drug application (ANDA) filing in China through China Food and Drug Administration (CFDA) and in Brazil through National Health Surveillance Agency (ANVISA).

 

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