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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 6
First page : ( 2966) Last page : ( 2970)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00525.9

A Forecast on Strategies for Regulatory Requirement of Drug Product Registration in African Pharmaceutical

Karthika Chenmala, Dr. Sureshkumar Raman*

Department of Pharmaceutics, JSS College of Pharmacy, Ooty (Affiliated to JSS Academy of Higher Education and Research)

*Corresponding Author E-mail: sureshcoonoor@jssuni.edu.in

Online published on 4 July, 2020.

Abstract

Generics are playing a vigorous role in human health. As there is a widespread growth in population, demand for different disease types have also been increased and where drug players are concentrating for newest design, growth and profit. Pharmaceutical product registration is a strenuous task for emerging markets, and also for regulated markets. Although the need for pharmaceuticals and its registration have been standardised and harmonised by various International agencies and Health Authorities in the countries still many of the manufacturers face difficulties in getting their product approval which is due to many changes and constant amendments or changes in the process, rules, guidelines. It is compelling that all emerging markets of pharmaceutical industry should follow the regulatory requirements set, henceforth for the betterment of public health. This following is about the emerging market “Africa” registration process of its pharmaceuticals and brief on challenges faced for acceptance and its market. This review mainly aimed at the African pharmaceutical regulations which are required for the drug products registration, such as the pharmaceutical products and its evolution in the emerging market, the steps involved in the registration processes from the initial step till the final approval.

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Keywords

Pharmaceutical product, Registration, International agencies, emerging market, African Pharmaceuticals.

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