(2002; 166 pages)
The South African experience
Ms Malebona Precious Matsoso, South Africa
One of the main aims of health sector reform in South Africa is to integrate a very fragmented health service and to develop a national drug policy and essential drugs programme, neither of which existed before 1994. The Medicines Control Council is moving towards performancebased units. It will base its work on an electronic regulatory system and is planning to acquire more in-house regulators. Improvements in the legislative framework are planned in relation to complementary medicine and harmonization. South Africa’s regulatory changes on parallel importation and generic substitution have already caused controversy. Other recent achievements of the agency include audits for clinical trials, setting-up of a law enforcement unit, GMP inspections of foreign manufacturers and safety monitoring of antiretrovirals.