SA’s [b]Department of Health[/b] will launch a spec ialised institute of regulatory medicine in April as one of the measures to improve the capacity of the [b]Medicines Control Council (MCC)[/b] to approve new drugs and clinical trials, according to [b]Health director-general Precious Matsoso[/b] in a [s]Business Day[/s] report. The institute is expected to fill an important gap in local training – at present no SA universities offer qualifications in the science behind regulating medicines.
The report says the Health Department was also exploring the scope for mutual recognition agreements between the council and other regulatory authorities, such as the [b]European Medicines Agency[/b], and the [b]UK’s Medicines and Health Products Regulatory Agency[/b], to speed up the MCC’s registration process. Matsoso said the capacity building was an important aspect of preparing for the launch of the [b]South African Health Products Regulatory Agency[/b], which would replace the MCC. The new body would have a wider ambit, and would introduce regulation of medical devices for the first time.
The MCC is, meanwhile, giving SA’s R8.5bn complementary medicines industry extra time. [s]Business Day[/s] reports that this was after virtually no manufacturers met its 15 February deadline for introducing new labels warning consumers that the products had not been evaluated for safety and efficacy. The labelling requirement is a key aspect of new regulations to the [b]Medicines and Related Substances Act[/b], gazetted on 15 November. But [b]Clicks COO Keith Warburton[/b] says that the industry is not ready, a view echoed by [b]Adcock Ingram CEO Jonathan Louw[/b]. Health Products Association treasurer Norman Fels said the 15 February deadline was ‘absolutely impossible’.
Researchers at the South African Medical Research Council have used the [b]Bangkok Declaration, Thailand, 2009[/b], as a guideline for their food composition activities. The vision is to build a comprehensive food composition database for the country. Activities are directed at increasing the number of food items with country-specific nutrient information; encouraging research organisations, universities and the food industry to become involved in nutrient data generation and the generation of yield factors for SA dishes.
[link url=http://www.bdlive.co.za/business/healthcare/2014/02/19/new-regulatory-institute-a-boost-for-medicines-council]Full Business Day report[/link]
[link url=http://www.bdlive.co.za/national/health/2014/02/17/alternative-medicine-deadline-missed]Full Business Day report[/link]
[link url=http://www.ncbi.nlm.nih.gov/pubmed?cmd=Retrieve&list_uids=23601390]Abstract: Food Composition Activities in SA[/link]