Medicines registration harmonisation: Focus on SADC after East African launch

East Africa celebrated the launch of its Medicines Registration Harmonisation Project in March. The Business Day, South Africa’s national business daily, was interested to find out what stakeholders, including the pharmaceutical industry, thought about what this meant for the wider region.

SARPAM director Dr Shaun Conway told the newspaper that the development was in the interests of regional integration. He added that regulatory authorities in the SADC have no option but to work together more closely to register and control medicines using the common set of regional minimum standards that they have agreed to.

Dr Conway said, “As we move towards greater regional integration, more medicines will cross the borders between SADC countries. So the challenge that all authorities in the region face is how to control the quality and authenticity of medicines for the benefit of everyone living in SADC.

“Regulatory authorities have no option but to work more closely together to register and control medicines using the common set of regional minimum standards that they have agreed to,” he said. The East African Community officially launched their medicines harmonisation project in Arusha, Tanzania at the end of March. The EAC has stolen a march on the SADC in this area despite the SADC having taken an early lead as far back as 1995 with the establishment of the Southern and Eastern African Medicines Regulatory Affairs Conference. This voluntary association of pharmaceutical manufacturers and NMRAs was driven by pharmaceutical industry associations from South Africa and Zimbabwe with the intention of harmonising regulatory requirements, focusing on registration processes, medicines control, labelling, package inserts and scheduling.

In recognition of the collaboration between SARPAM and the Nepad Agency towards the ultimate success of the SADC medicines registration harmonisation project, Celestine Kumire, SARPAM’s programme manager, was invited to give a presentation at the launch of the East African project. SARPAM and Nepad convened the Lilongwe meeting of May 2011, where a proposal for harmonisation of medicines registration was agreed in the first tangible step towards formulating the SADC proposal. Since then SARPAM has commissioned two experts in medicines regulatory affairs to explore and report on the current state of affairs in the SADC region. The findings of these two consultants will be presented to the SADC Member States during the Access to Medicines conference that is taking place in June.