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Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)


ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

Comparative Study of Generic Drug Registration Requirements for Dossier Submission in African Region-Kenya, Ghana, Nigeria, and Botswana

Author(s): Nandini Warier and Priti Mehta

Volume 3 , Issue 2 , 2016

Page: [71 - 81] Pages: 11

DOI: 10.2174/2213476X03666160605111335

Price: $65


Background: Regulation of drugs across the world has been a crucial component in providing quality products around the globe. Henceforth different drug administrative powers are moving forward for initiating better regulatory framework which will lead to easier differentiation of superior medicinal products to that of sub-standard ones. For this purpose legitimate dossier preparation becomes essential so that a worthy drug gets registered with better evaluation process instead of getting rejected due to various hindrances. The pharmaceutical markets are established all around the world depending upon the qualitative and complexity of the regulations implied and as a result it has been divided into regulated and emerging markets. Amongst the emerging markets, Africa is considered as long term opportunity for pharmaceutical investment, with GDP of $ 2.9 trillion. This article provides a detailed comparative study of the specifications to be noted during generic drug registration documentation in African region emphasizing more on Kenya, Ghana, Botswana, and Nigeria. Hence this article will ultimately lead to a clearer view of dossier registration variations within these regions and will help in systematic acceptance of essential medicines for more prominent purposes in near future.

Conclusion: Comparative finding of regulatory requirements in African countries provide with the understanding of variations which are to be considered during drug registration in such countries despite the fact that harmonization is taking place at an extensive pace. It can also be concluded that African countries are rapidly developing their regulatory needs for compliance with stringent authorities with concern of procuring better health products.

Keywords: Africa, quality, sub-standard, pharmaceutical investment, emerging market, dossier, regulatory.

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