An evolving role for non-governmental organizations dealing with registration backlogs and rising costs: the example of cancer biosimilars in South Africa

Abstract: Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical […]


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

Abstract: 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. Submitted: 25 February 2015; […]