South Africa's Medicines Council calls on Pharma to help with drug approval backlog

The Medicines Control Council in South Africa has asked the pharmaceutical industry for help to reconcile its records for outstanding applications to register new medicines, as part of a ministerially-backed push to deal with its huge backlog.

It is an important development for the pharmaceutical industry, which has long complained of extensive delays in getting new products registered, notes the local newspaperp.Business Today. By law, all medicines must be registered with the council before they may be marketed or sold.

Health Minister Aaron Motsoaledi has given his support to recommendations which consultants made to former Health Minister Barbara Hogan that emphasized the importance of reforming the council to speed up access to new drugs and cheaper generic medicines.

It takes between three and four years for the Council to approve applications to register new products at the moment, said Val Beaumont, head of Innovative Medicines SA (IMSA) - which represents multinational pharmaceutical firms. Only two thirds (2,428) of the 3,731 applications for New Chemical Entities, generic copies or changes to product information leaflets were approved between 2003 and 2007,the IMSA said. More than 2000 product registration applications are stuck in the pipeline, IMSA said. "We are very excited about what we see happening and very grateful that Minister Motsoaledi is speeding up patient access to new medicines," Ms Beaumont added.