South Africa has a new medicines regulator
PHOTO: NIAIDThe board of the South African Health Products Regulatory Authority (SAHPRA) held its inaugural meeting on 1 February 2018, according to Department of Health spokesperson Popo Maja. The inaugural board meeting officially brings SAHPRA into existence. This means that South Africa’s old regulatory authority, the Medicines Control Council (MCC), no longer exists.
According to a Department of Health media statement, Portia Nkambule, previously a Director in the Cluster: Food Control, Pharmaceutical Trade & Product Regulation, who acted as secretariat to the MCC, has been appointed as the Acting SAHPRA CEO. The statement also announced the names of the fifteen members of the SAHPRA board.
“What we are aiming for with the newly constituted SAHPRA is an efficient, relevant and transparent regulatory authority that ensures that South Africans have access to safe, effective, good quality medicines and medical devices, and the information that allows them to use these products with confidence,” said Professor Helen Rees, chairperson of the SAHPRA board.
Over the last two decades the MCC has been criticised for inefficiency, taking too long to register medicines, and a lack of transparency.
Growing capacity
“All outstanding work that was being done by the MCC will be continued by SAHPRA. The Authority will utilise external experts for evaluation of applications, but over time it will actively grow the in-house capacity of the staff to take over the bulk of its work including registration of medicines and evaluations for clinical trials,” the statement read. “In addition, agreements will be made for recognition of work from recognised international regulatory authorities, resulting in more rapid evaluation timelines.”
The scope of the new Authority has expanded to include not just medicines, but also medical devices (including in vitro diagnostics) and aspects of radiation control.
Maja told Spotlight that “SAHPRA will be partly reliant on Government funding through public money, by means of a transfer from the Revenue Fund, and partly from funds (fees) raised for services rendered within its regulatory ambit.”
The fifteen members of the board are:
- Prof Helen Rees (Chairperson)
- Dr Nonhlanhla Madela-Mntla
- Prof Shabir Banoo
- Dr Henry Leng
- Dr Thapelo Motshudi
- Prof Kelly Chibale
- Prof Aimes Dhai
- Prof Jeffrey Mphahlele
- Dr Ushma Mehta
- Dr Mphane Molefe
- Adv Hasina Cassim
- Ms Mandisa Hela (Vice-Chairperson)
- Ms Lesibana Fosu
- Mr Norman Baloyi
- Prof Craig Househam