SOUTH AFRICAN DRUG AGENCY REFORM WORRIES CRITICS

Opponents of ongoing reforms to South Africa's Medicines Control Council (MCC) have voiced concerns that the process could see the newly-appointed national registrar take a less independent role in drug regulatory issues. The MCC is responsible for evaluating drug safety and clinical trial activity in South Africa.

The previous registrar left the agency suddenly in October 2005, in the wake of a court decision throwing out the government's controversial pharmaceutical pricing framework. The department is currently being restructured, as officials draw up a revised set of pricing regulations.

However, sources in the pharmaceuticals industry claim that this restructuring process could result in a less balanced regulatory system in South Africa. Further, the MCC has been criticised for severe backlogs in product approvals, a situation the MCC attributes to a lack of local expertise.