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The impact of the Medicines Control Council backlog and fast-track review system on access to innovative and new generic and biosimilar medicines of public health importance in South Africa

Lookup NU author(s): Professor Allyson PollockORCiD


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© 2016, South African Medical Association. All rights reserved.The fast-track registration policy of the South African National Department of Health allows for rapid registration of new medicines of public health importance and of all medicines on the Essential Medicines List, most of which are generics. No limit is placed on the number of generic brands of a medicine that can be submitted for fast-track registration. This, together with resource constraints at the regulator, may delay access to important new medicines, new fixed-dose combinations of critical medicines or affordable versions of biological medicines (biosimilars). One reason for not limiting the number of fast-track generic applications was to promote price competition among generic brands. We found this not to be valid, since market share correlated poorly with price. Generic brands with high market share were, mostly, those that were registered first. We propose that the number of generic brands accepted for fast-tracking be limited to not more than seven per medicine.

Publication metadata

Author(s): Leng HMJ, Pollock AM, Sanders D

Publication type: Article

Publication status: Published

Journal: South African Medical Journal

Year: 2016

Volume: 106

Issue: 4

Pages: 350-353

Print publication date: 01/04/2016

Online publication date: 17/03/2016

Acceptance date: 09/11/2015

ISSN (print): 0256-9574

ISSN (electronic): 2078-5135

Publisher: South African Medical Association


DOI: 10.7196/SAMJ.2016.v106i4.10237

PubMed id: 27032846


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