Title:Comparative Study of Generic Drug Registration Requirements for Dossier Submission in African Region-Kenya, Ghana, Nigeria, and Botswana
Volume: 3
Issue: 2
Author(s): Nandini Warier and Priti Mehta
Affiliation:
Keywords:
Africa, quality, sub-standard, pharmaceutical investment, emerging market, dossier, regulatory.
Abstract: 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.
