Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2018 Vol: 10 Issue: 6

Harmonization of Drug Registrationn Requirements in African Countries


The constant availability of affordable medicines of assured quality, safety and efficacy is an important aspect of any national health system. Providing quality and affordable medicines to the population is a complicated undertaking, ranging from the identification and selection of drugs to the procurement and quality assurance of medicines circulating on the market. It is notable that each individual country in Africa has its set of requirements for drug registration, where individual filings are supposed to be done for each country, which results in the cumbersome process requiring considerable technical information from applicants. As a result, it is sometimes difficult to get companies to comply fully with the registration process, as the costs of dossier submission and complying with a gamut of requirements may outweigh the benefits, which finally results in the delay of drug approval process, delay in the access of safe, quality and efficacious medicines to the people. Considering the drug registration requirements of African countries, it is evident that even though each country wants a separate filing for drug product registration, the registration requirements are more or less the same. If the initiative of Harmonization is considered for drug registration, it will result in the uniformity of drug registration requirements among the African countries, which further result in the quick drug approval process, early access to medicines and the initiative of harmonization will save the resources of drug regulatory authorities and industry experts and it prevents the duplication of data.

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