Abstract

IMPLEMENTATION OF BIOEQUIVALENCE STUDIES FOR APPROVAL OF GENERIC DRUG PRODUCTS IN SUDAN: CURRENT STATUS

Abubakr O. Nur*, Abdelhalim B. Mahmoud, Zuheir A. Osman, Mohammed E. Abdelmageed

ABSTRACT

Number of registered medicines in Sudan approaches 5000, of which 84% were account as generic products that imported to constitute 70% of the total Sudanese drug market. National Medicines and Poison Board, as a national drug regulatory authority, has adopted bioequivalence study as one among other requirements for approval or re-approval of these generics. This study aims to highlight the current situation and the associated problems with regard to implementation of BE studies as a regulatory tool for drugs market authorization in Sudan through retrospective reviewing of relevant documents bearing in mind the applicability of biowaiver concept. Results has indicated that study cost, approval delay, limitation of available or approved bioequivalence centers and wavering in bioequivalence studies recommendations between World Health Organization and Harmonized Arab Guidelines on bioequivalence studies were the main problems associated with the bioequivalence implementation. Moreover, the study revealed a discrepancy in the consideration of BCS based biowaiver concept by the National Medicines and Poison Board for the approval of biowaiver eligible drug products, as compared to relevant guidelines of World Health Organization and the Harmonized Arab Guidelines. The study concluded that revision of NMPB documents related to implementation of bioequivalence studies so as to remove the existing discrepancies, consideration of BCS based biowaiver concept in the approval of drug generic products, establishment or nomination of more national bioequivalence centers and conduction of effective post marketing surveillance would improve the legislation and regulation of both biowaived and non-biowaived generic drug products

Keywords: Bioequivalence Studies, National Medicines and Poison Board, BCS Biowaiver, Harmonized Arab Guidelines.