Open AccessREGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA
Author(s) -
G Raja Mohan Reddy,
M. P. Venkatesh,
J Achin,
T. M. Pramod Kumar
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i2.126
Subject(s) - business , regulatory authority , product (mathematics) , market access , quality (philosophy) , certificate , marketing , pharmaceutical industry , risk analysis (engineering) , industrial organization , medicine , pharmacology , computer science , ecology , philosophy , geometry , mathematics , public administration , epistemology , algorithm , political science , biology , agriculture
Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Ghana is considered as one of the growing pharmaceutical market in east Africa. Of late, generic drugs are holding a major stake in the pharmaceutical market and are gaining more and more confidence in the usage. Majority of medicines in the Ghana are generic drugs which are considered as value for the money and affordable. With Ghana Regulatory Authority is the Food and Drugs Board, which takes decision to register the product and issues Registration Certificate. This study mainly focuses on the regulatory environment, registration process involved and the regulatory requirements that are applicable for the generic drug products in Ghana.