University of Khartoum

Implementation of Bioequivalence Studies in Sudan: Regulatory Perspective

Implementation of Bioequivalence Studies in Sudan: Regulatory Perspective

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Title: Implementation of Bioequivalence Studies in Sudan: Regulatory Perspective
Author: Nur, Abubakr O.; Mahmoud, AB
Abstract: Preface: Number of registered medicines in Sudan exceeds 3700 brands of 812 generics. Imported medicines represents more than 70%, of which 80% are imported from India ,Egypt, Syria ,Jordan and Pakistan . Objectives: To highlight the current situation of implementing bioequivalence studies in Sudan and difficulties facing such implementation, the reasons for and solutions thereof. Methodology: This research was conducted depending on all official documents related to bioequivalence issues in Sudan that was published by the national medicines and poisons board (NMPB) during the period 2009-2011. Available (WHO ESSENTIAL MEDICINE LIST) generics were listed, classified according to their biopharmaceutics classification system (BCS) and the recommendations of the WHO were compared to that of the national medicines and poisons board (NMPB). Results: It has been shown that among the (123) medicine listed in the WHO Essential medicines list, the number of registered medicines in Sudan was found to be (94) generics of 76.6%. According to BCS ,of the (94) generics mentioned in the WHO essential medicine list ,it was found that (62) generics, representing(682) brands with percentage (71.4%) of total brands are eligible for biowaiver , 25 generics , representing (221) brands (23.2%) are not eligible ,6 generics ,representing (50) registered brands of (5.2% )are not applicable and 1 generic , representing 1 brand 0f ( 0.1%) is not relevant. Comparing this to the studies recommended by the NMPB for the same selected generics, it shows that 78 generics (82.9%) of the 94 generics require In vivo bioequivalence study,1 generic (1.06%) require In vitro dissolution test , 2 generics (2.13%) do not require bioequivalence study and 13 generics (13.83%) in which the recommended studies are not mentioned . Conclusion: The result concluded that National drug regulatory capacity needs to be strengthened to carry out both pre and post marketing studies and pharmacovigilance surveillance, which are, in the mean time, more urgent than the adoption of BE studies. Moreover, Implementation of bioequivalence studies as registration requirement should be adopted in step-wise manner to enhance applicability for both manufacturers and the drug regulatory authority.
URI: http://khartoumspace.uofk.edu/123456789/27782


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