E-DRUG: African Ministers of Health adopt treaty to establish African
African Union Ministers of Health adopt treaty for the establishment of the
African Medicines Agency
Treaty to be submitted to the Specialised Technical Committee on Justice and
Legal Affairs later on this year
Geneva?20 May 2018: African Ministers of Health, Saturday meeting as a
Working Group of the Specialised Technical Committee on Health, Population
and Drug Control unanimously adopted the Treaty for the establishment of the
African Medicines Agency (AMA).
AMA seeks to ensure the coordination and strengthening of continental
initiatives to harmonise medical products regulation, provide guidance and
technical support to improve access to quality, safe and efficacious medical
products and health technologies on the continent. AMA will work within the
existing continental architecture of Regional Economic communities (RECs)
and Regional Health Organizations (RHOs) to support AU Member States.
?The African Medicine Agency is a key element of the architecture for
harmonisation of continental, institutional, scientific and regulatory
resources to improve access to safe, efficacious and quality medicines? said
Ambassador Ajay Kumar Bramdeo, the Permanent Observer of the African Union
to the United Nations Office at Geneva.
The African Medicines Agency will promote the adoption and harmonization of
medical products regulatory policies and standards, and scientific
guidelines, and coordinate existing regulatory harmonization efforts in the
Regional Economic Communities and Regional Health Organisations. It will
further provide regulatory guidance, scientific opinions and a common
framework for regulatory actions on medical products, as well as priority
and emerging issues and pandemics.
The Specialised Technical Agency will also provide regulatory guidance and
provide technical assistance on regulatory matters to countries that lack
the capacity and resources to do so. It will further provide guidance on
regulation of clinical trials on medical products and health technologies as
well as traditional medical products.
?It is increasingly becoming evident that no single country has enough
resources and capability to efficiently and effectively regulate the whole
supply chain system alone in this globalised world. AMA thus occupies a
distinct position to leverage various regulatory assets and capabilities to
improve access to safe, effective, good quality and affordable essential
medicines and health technologies? said Gugu N. Mahlangu, Director-General
at Medicines Control Authority of Zimbabwe who also Chairs the AMA
The new institution will also lead the establishment and strengthening of
Regional Centres of Regulatory Excellency in order to develop the capacity
of medical products regulatory professionals. Other key mandates will
include the promotion of international cooperation and partnerships for the
mobilization of financial and technical resources. The agency will promote
and advocate for the use of the AU Model Law on Medical Products Regulation
in Member States and RECs to facilitate regulatory and legal reforms at
continental, regional and national levels.
Through AMA systems to monitor, evaluate and assess the comprehensiveness of
national medical products regulatory systems with be further enhanced to
ensure efficiency and effectiveness. The Agency will play a lead role in
mobilising regulatory expertise across the continent and beyond to provide
scientific opinions in consultation with affected Member State National
Medical Regulatory Agencies in the event of a public health emergency on the
continent with cross border or regional implications where new medical
products are to be deployed for investigation and clinical trials.
About the African Union
The African Union spearheads Africa?s development and integration in close
collaboration with African Union Member States, the Regional Economic
Communities and African citizens. AU Vision An integrated, prosperous and
peaceful Africa, driven by its own citizens and representing a dynamic force
in global arena.
Learn more at:
Hlazo Mkandawire <HlazoM@nepad.org>