The South African government pledged to clear the backlog of drug approvals and develop a recovery strategy for the pharmaceutical industry, in September 2009.
The Medicines Control Council (MCC) attributed the backlog to an unexpected increase in submissions for the registration of medicines during the last three years.
Since Mr Motsoaledi took over as Health Minister on 11th May 2009, he has voiced his commitment to healthcare reform, including making changes to the MCC to speed up access to new medicines and expand the availability of generic medicines.
The MCC is undertaking a 12 million rand (£990,000) backlog clearance project, with funding from the UK’s Department for International Development (DFID). The industry association, Innovative Medicines SA (IMSA), has welcomed the project as it said the current approval process can take up to four years and more than 2,000 applications are now stuck in the pipeline.
Further reading - A detailed analysis of the South African pharmaceutical market, including some background information on the drug approval process, is available from Espicom: The Pharmaceutical Market: South Africa (published June 2009)