Module 1 2021

25/06/2021

MEA Regulatory Overview Harmonization

● Gulf Central Committee for Drug Registration ● Approved in May 1999. ● Seven Member countries: KSA, UAE, Kuwait, Qatar, Bahrain, Oman and Yemen ● Population ~ 70 million • Harmonization and co-operation initiatives - GCC-DR ● Total pharmaceutical market size: US$ 13.9 Billion (2018 estimate), estimated US$ 25 Billion by 2025 ● Grant manufacturing site and product approvals that cover the seven member states ● A national procedure in each country should follow - which is not well defined – in order to obtain a final approval per country

● Recommended for Generics and Biosimilars ● Clinical trials not yet centrally regulated

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Harmonization and co-operation initiatives - Africa

● Several initiatives: ● AMRH: Africa Medicine Regulatory Harmonization ● AMRH consists of a number of constellations:

- WAHO/UEMOA, - ECCAS / OCEAC, - IGAD / AMU / CEN-SAD, - EAC, - SADC/ COMESA ● East African Community progressing in the implementation of EAC MRH ● ZAZIBONA is a collaboration between national medicines regulatory authorities (NMRAs) in Botswana, Namibia, Zambia & Zimbabwe.

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