Drug authorities can share evaluations

‘SA wants to work with FDA to avoid work being duplicated’

THE MEDICINES Control Council (MCC), which has long been criticised for the delay in registering new medicines, may soon be able to speed up its processes – that’s if an international conference being held in Cape Town bears fruit.

The World Health Organisation’s 17th International Conference of Drug Regulatory Authorities (ICDRA), focuses on the need for greater international collaboration between national regulatory authorities to improve access to new drugs and devices.

It’s the first time the WHO’s 194 member states and regulators from 98 countries are convening in Africa.

MCC registrar and convener of the conference Dr Joey Gouws said it was hoped the gathering would bring an end to the duplication of registrations globally, widely believed to be the cause of the backlogs in registrations.

“We hope to learn from these collaborations and harmonisations, and hopefully apply it at home.

“In South Africa we want to have a greater convergence with other regulatory authorities, such as working with the FDA (US Food and Drug Administration) so that we don’t duplicate work unnecessarily.

“At the moment there is no convergence, and this means that regulators can’t even share reports on drugs they’ve already reviewed,” she said.

Gouws said new legislation governing the SA Health Products Regulator, which replaces the MCC in April, allows for the sharing of information.

Under the theme “Patients are waiting: how regulators collectively make a difference”, the delegates will also be updated on epidemics around the world, including the Zika virus outbreak.

Dr Suzanne Hill, WHO director for essential medicines and health products, said sub-Saharan Africa had made good progress recently to improve regulatory performance and ensure patients can access safe and effective essential health products.

“But we need to keep up the momentum and governments must invest more resources into this area.

“Strengthening the role of regulatory authorities will bring us closer to realising universal health coverage and universal access,” she said.