生物等效性和生物利用度杂志

抽象的

Evaluation of the Bioequivalence Documentation Required For Registration of Generic Drug Products in Burkina Faso: Methodology of Implementation and Impact

Rasmané Semdé, Josias Bg Yameogo, Natacha L.S.M Toe Djiguemde, Roland Nao, Charlemagne Gnoula, Charles B Sombie and Jean-Baptiste Nikiema

With a view to better warranty quality, efficacy and security of generic medicines, the national medicine regulatory authority (NMRA) of Burkina Faso has firstly evaluated in 2009, the country marketing authorization legal provisions and procedures. Then, a new procedure intended to enforce the technical evaluation of the registration applications has been adopted and progressively implemented during 2010 and 2011. This evaluation included the compliance of generic drugs to the quality and bioequivalence requirements. The results of the evaluations of the bioequivalence documentations provided in 2009, 2010 and 2011 for the registration of generic drugs were collected, analyzed and compared. Only the capsule and tablet oral dosage forms were considered in this study. The implementation of the new procedure did not discourage the applicants since the number of the drug registration applications has progressively increased from 2009 to 2011. More than 72% and 54% of the applications respectively concerned generic drugs and generic oral solid forms (tablets and capsules). These included various therapeutic groups and were mainly manufactured in Asia, Europe and Africa. The adjournment rates of the registration applications, whatever the reasons, were 11.1%, 32.5% and 51.9% in 2009, 2010 to 2011, respectively. Those for absence or non compliance of bioequivalence documentation were also dramatic and progressively increased from 0%, 26.4% and 51.4% in 2009, 2010 and 2011, respectively. This work shows that implementation of a more rigorous bioequivalence evaluation for registration of generic drugs is not only benefic and necessary in term of public health but also, performable in the sub-Saharan African developing countries.