Agency overview | |
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Formed | Proposed |
Jurisdiction | African Union |
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The African Medicines Agency (AMA) is a proposed specialised agency of the African Union (AU) intended to facilitate the harmonisation of medical regulation throughout the African Union. Following a similar model to that of the European Medicines Agency, it is intended to have a wide scope covering medicines, traditional medicine, and medical devices.
The AMA is the latest step in efforts by the AU and regional African bodies to improve medical capacity in the continent. Such efforts are intended to address a deficiency in drug production and challenges posed by counterfeit and substandard products. Once it is created, it is expected that the AMA will supervise and absorb roles currently carried out by other bodies, such as regional harmonisation efforts and pan-AU creations such as the African Medicines Regulatory Harmonization (AMRH) initiative and the African Vaccines Regulatory Forum (AVAREF).
The Treaty for the Establishment of the African Medicines Agency was adopted by the AU in February 2019. It came into effect on 5 November 2021, after ratification from the 15th AU member states, Cameroon. [1]
The proposed African Medicines Agency (AMA) is a continuation of existing medical regulatory harmonisation efforts in the continent. [3] [4] Across Africa it is estimated that only 3% of required drugs are produced, [5] with medicines not readily available during health emergencies. [6] The roughly 375 medicine manufacturers on the continent produce only 10-30% of drugs used in Africa. [7] Another challenge is the proliferation of substandard and counterfeit medical products. [8] Porous borders make it easy for such products to move within the continent, and there is significant variation in the quality of current medical regulation between countries in the African Union (AU). [9] While every country except the Sahrawi Arab Democratic Republic has a National Medicines Regulatory Authorities (NMRAs), many are unable to carry out many expected essential functions. The WHO considers 90% of African countries to have minimal to no medical regulatory capacity. Many medicines are not distributed to some countries due to the length of time needed to receive regulatory approval. [4]
In 2005 the AU decided to create a “Pharmaceutical Manufacturing Plan for Africa”. [10] Under this the African Medicines Regulatory Harmonization (AMRH) initiative was established in 2009, [4] and fully launched in 2012. [3] The AMRH represented the first time that NMRAs within Africa worked together. [7]
During the 1st African Ministers of Health meeting, which ran on 14–17 April 2014 in Luanda, member states were requested to allocate resources for a potential African Medicines Agency as part of their efforts to improve medical regulatory harmonisation. [10] The same year saw the creation of 11 “Regional Centres of Regulatory Excellence”. [4] The proposed agency was inspired by the European Medicines Agency. [3] It is expected that the work of the AMRH will eventually come under the purview of the AMA. [7]
In 2016 the Model Law on Medical products Regulation was endorsed by the AU. This law serves as a model for national regulatory laws and facilitates harmonisation between countries, [4] and is promoted by AMRH. [3] An existing multi-country vaccine testing scheme, African Vaccines Regulatory Forum (AVAREF), is expected to expand under the AMA to cover other medicine and medical devices. [3]
The concept of an African Medicines Agency had unanimous support within the AU. [7] The Treaty for the Establishment of the African Medicines Agency was adopted in February 2019 during the 32nd Ordinary Session of the Assembly of the African Union. [11] This was done through decision Assembly/AU/Dec.735(XXXII), which reaffirmed decision EX.CL/1141(XXXIV) from the 34th Executive Council ordinary session. [10]
Countries can sign the treaty either at the AU headquarters in Addis Ababa or in their own territory. [12] It was written to enter into force 30 days after the 15th instrument of ratification and ascension was deposited with the AU. [13]
The AU's Specialised Technical Committee Meeting on Health, Population and Drug Control called for “urgent” ratification in August 2019, at which point only four out of the 15 necessary countries had ratified the treaties. Support also came from the AU Commission for Social Affairs. [11]
Dr. Margaret Agama-Anyetei, head of health, nutrition, and population at the African Union Commission, has stated that the COVID-19 pandemic highlights the need for such a body, and hopes that quick ratification would allow the AMA to play a role in distributing relevant drugs and vaccines throughout Africa in the coming years. [9] The Pan-African Parliament has also cited COVID-19 as an example of the need for the AMA. [14] In June 2020, the "Africa Medical Supplies Platform" was established by the AU to help combat COVID-19. [15]
The AMA is designed as a special agency of the African Union. Its aims will be to strengthen the capacity of AU countries to regulate medicines and related products, provide regulatory guidance, and harmonise medical regulation efforts across the continent. This harmonisation covers the actions of member states, the African Union Commission, Regional Economic Communities (RECs), and Regional Health Organisations. [8] The AMA will build upon closer regional integration, [10] [5] which has already served to reduce drug prices and the time needed for regulatory approval. [7] The ARMH worked through RECs, [4] and it has been suggested that these regional bodies become technical working groups within the AMA. [16] Countries who have signed and ratified the agreement will be asked to bid to host its headquarters. [10]
Medical products that would be covered include drugs, vaccines, medical devices, blood products, diagnostic tools, and traditional medicine. It is expected the body would work closely with the existing Africa Centres for Disease Control and Prevention. [9]
The AMU is viewed as important due to the development of the African Continental Free Trade Area, which is expected to develop into the African Economic Community by 2028. [10] Regional regulatory harmonisation within the East African Community, developed under the AMRH, was based on a free trade agreement within that grouping. [17]
The Treaty for the Establishment of the African Medicines Agency came into effect on 5 November 2021 after the ratification of 15 countries. As of October 2022, 33 out of the 55 Members of the African Union have either signed or ratified the treaty. [18]
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
The Australian Medical Association (AMA) is an Australian public company by guarantee formed as a professional association for Australian doctors and medical students. The association is not run by the Australian Government and does not regulate or certify doctors, a responsibility which lies with the Medical Board of Australia and the Australian Health Practitioner Regulation Agency. The association's national headquarters are located in Barton, Australian Capital Territory, in addition to the offices of its branches in each of the states and territories in Australia.
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The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.
The Constitutive Act of the African Union sets out the codified framework under which the African Union is to conduct itself. It was signed on 11 July 2000 at Lomé, Togo. It entered into force after two thirds of the 53 signatory states ratified the convention on 26 May 2001. When a state ratifies the Constitutive Act, it formally becomes a member of the AU. All 55 signatory states have ratified the document, with South Sudan and Morocco ratifying as the last African states.
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods.
The African Economic Community (AEC) is an organization of African Union states establishing grounds for mutual economic development among the majority of African states. The stated goals of the organization include the creation of free trade areas, customs unions, a single market, a central bank, and a common currency thus establishing an economic and monetary union.
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The African Union (AU) is a continental union consisting of 55 member states located on the continent of Africa. The AU was announced in the Sirte Declaration in Sirte, Libya, on 9 September 1999, calling for the establishment of the African Union. The bloc was founded on 26 May 2001 in Addis Ababa, Ethiopia, and launched on 9 July 2002 in Durban, South Africa. The intention of the AU was to replace the Organisation of African Unity (OAU), established on 25 May 1963 in Addis Ababa by 32 signatory governments; the OAU was disbanded on 9 July 2002. The most important decisions of the AU are made by the Assembly of the African Union, a semi-annual meeting of the heads of state and government of its member states.
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The African Continental Free Trade Area (AfCFTA) is a free trade area encompassing most of Africa. It was established in 2018 by the African Continental Free Trade Agreement, which has 43 parties and another 11 signatories, making it the largest free-trade area by number of member states, after the World Trade Organization, and the largest in population and geographic size, spanning 1.3 billion people across the world's second largest continent.
The Treaty for the establishment of the African Medicines Agency is an international treaty, pending ratification and accession by at least 15 Member States of the African Union, to establish the African Medicines Agency (AMA) as a specialized agency of the African Union. The aim of the treaty, by establishing the AMA, is to address the issue of the availability and quality of medical products in Africa by coordinating the continent's regulatory structure regarding the production and distribution of pharmaceuticals, medical devices and other medical products.
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