The World Health Organization (WHO), a United Nations agency, and the African Medicines Agency (AMA), an agency of the African Union, signed A cooperation framework agreement was signed on Friday aimed at strengthening regulatory systems and improving access to safe, efficient and quality-assured healthcare products across the African continent.
The Collaboration Framework Agreement establishes a partnership between WHO and the AMA to advance the harmonization of regulatory frameworks across Africa and support the operationalization of the AMA as a continental regulatory institution overseeing access to safe and quality-assured medical products.
Dr. Yukio Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, said: “The launch of this collaboration framework is a crucial step towards building a more unified, efficient and resilient regulatory ecosystem in Africa, benefiting not only the continent but the world.”
The agreement deals with long-standing challenges that have hindered African nations’ access to safe and quality healthcare products, such as: B. fragmented regulatory systems, limited market supervision, limited local manufacturingand the danger of inferior and counterfeit medical products. It forms the basis for joint operational plans for the next three to five years, during which WHO and AMA will work together to ensure that African nations have access to safe and quality medical products. Key strategies include promoting harmonization of regulations, strengthening safety surveillance and response to counterfeit health products, and supporting local innovation and production of medicines.
WHO stressed that this agreement represents a “historic opportunity” to transform medical device regulation across Africa by improving collaboration, reducing regulatory fragmentation and accelerating access to safer medicines for all Africans. To pursue these goals, both WHO and AMA called on Member States and international partners to support these efforts by advancing necessary reforms, accelerating treaty ratification and investing in a trusted and harmonized regulatory ecosystem.
The framework agreement for cooperation was launched on the sidelines of the year Seventy-ninth World Health Assembly (WHA79)which brought together health ministers, African Union institutions, national regulators and global partners to strengthen their commitment to regulatory reform and investment in strengthening regulatory systems. The agreement also comes at a critical time for Africa as the continent grapples with current issues Ebola outbreak in the Democratic Republic of Congo (DRC) and Uganda. On May 17, the Director General of the WHO said explained The outbreak constitutes a public health emergency of international concern Article 12 of the International Health Regulations.
