Govt to establish Institute for Regulatory Science

Tuesday, February 18, 2014

Pretoria – Health Minister Aaron Motsoaledi has announced that his department will this year establish the Institute for Regulatory Science.

Addressing media in Cape Town on Tuesday, the minister said the number of drugs that will need to be registered through the regulatory authority, the Medical Control Council, was “staggering” but none of the universities in South Africa offer any course in regulatory medicine to train regulators. 

“Hence we shall establish this year an institution for regulatory medicine to start with 35 students who have Masters Degrees in Science,” said Motsoaledi during a post-State of the Nation Address briefing.

Director General Malebona Precious Matsoso said the Health Department had set up a task team with experts from different universities and the Gates Foundation, the European Union and the World Health Organisation to establish the Institute for Regulatory Science.

She explained that the institute would be a formal structure that trains regulators, also a hub for training regulatory pharmacists in the industry.

In preparation for the establishment of the institute, the department had sent a team of people to Switzerland to visit Swiss Medic, to the UK to the Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency to observe their methods and approaches.

“We have 35 people who are ready. The training is supposed to start in April. It’s a joint programme with the University of the North West and we’ve recruited students from the University of Pretoria and Rhodes University. We also had some unemployed graduates who had MSc and MPharm Degrees,” said Matsoso.

The proposed amendments to the Medicines and Related Substances Act aim to create the South African Health Products Regulatory Authority (SAHPRA).

The new authority will replace the current MCC.

The proposal is to bring the medical devices’ industry, cosmetics and foodstuffs as well as pharmaceuticals under the jurisdiction of SAHPRA. The hope is that this long awaited regulatory body will speed up the registration of generic medicines. –