Module 1 2021

25/06/2021

MEA Regulatory Overview Harmonization 41

Africa Medicines Agency (AMA) - endorsed by Africa Union Heads of State Summit - February 2019 The AMA functions are proposed to include : • Regulatory system strengthening • Providing technical support during marketing authorisation reviews • Information sharing on substandard and falsified medicines • Inspections of marketed products • Work with Regional Economic Communities and National Regulatory Medicines Agencies to co-ordinate reviews • Support the strengthening of quality control laboratories • Promote regulatory harmonisation. National Agencies will continue to maintain sovereignty and perform core regulatory reviews , such as • New product reviews • CTAs • Post Marketing • Labelling / Advertising and promotional material • etc

The Organisation for Professionals in Regulatory Affairs

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MEA: Overall Drug Registration Requirements

• CTD format mandatory • eCTD Saudi Arabia, United Arab Emirates, Oman, Bahrain, South Africa and Kenya • Local entity legally required to apply for a MAA • Most countries require CPP by Reference Agency - however, Reference Country is defined differently (MAH, bulk manufacturer, batch releasing country) • Stability studies (Climatic Zone IV in many countries) • Samples • Labelling (English/French + Local) • Module 1 (Country Specific Requirements…CPP, CoA, Application forms etc.)

The Organisation for Professionals in Regulatory Affairs

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