Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines

by Henry MJ Leng , David Sanders and Allyson Pollock
Generics and Biosimilars Initiative (GaBI) – Published online first: 24 April 2015

9 pp. 360 kB
http://apps.who.int/medicinedocs/documents/s22089en/s22089en.pdfImage 002

The backlog in medicines registration in South Africa is a result of the implementation of pro-generics policies without strengthening the regulator to handle the substantial increase in registration applications that followed. Despite the backlog, more than enough generics are registered to promote price competition and ensure access to affordable medicines.

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