Registering medicines a lot faster

THE Presidency has announced that President Jacob Zuma has signed into law the Medicines and Related Substances Act, 2015, amending the Medicines and Related Substances Amendment Act, 1965

The Star, 15 January 2016

And with the newly amended act it is out with the Medicines Control Council (MCC), which has been the regulatory body in the country for medicines, and in with the new South African Health Products Regulatory Authority (SAHPRA). Health Minister Aaron Motsoaledi said that 2009 when he became Minister, he found a backlog as long as six years in registering medicines in the country; and with a backlog that long, it is not efficient for the pharmaceutical companies or for the population. He said it wasn't even regulating everything.

It wasn't regulating medical devices or complementary medicines. Motsoaledi said SAHPRA would be a bigger and more effective structure, armed with a bigger staff complement, as opposed to the 100 employees at the MCC. It will be an independent organ of state and will have a mandate that includes management of registration and control of medicines, complementary medicines, clinical trials, active pharmaceutical ingredients, medical devices and in-vitro diagnostic medical devices.

The Minister said work to transform the MCC had begun as early as 2009, and last year it revved up its goal to regulate complementary medicines by recalling all sexual enhancers, skin-lightening creams and unverified products, with the deadline having been November 15 last year for companies to bring the products in for testing.

Products which fail to prove their efficacy will be scrapped. Motsoaledi said mineral supplements and body-building supplements would be called in for verification testing in May. The new body will be funded by both the state and the private sector - which will now be paying heftier levies to have their medicines registered to assist in quickening the pace of registration.