African Medicines Agency

Last updated
African Medicines Agency
Agency overview
FormedProposed
JurisdictionAfrican Union
Map
African Union (orthographic projection).svg

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.

Contents

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 headquarters of the AMA will be located in Rwanda. [2]

History

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]

Structure

The African Medicines Agency is expected to work with regional bodies, similar to those underpinning the African Economic Community. RECs of the AEC.svg
The African Medicines Agency is expected to work with regional bodies, similar to those underpinning the African Economic Community.

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]

Status

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 November 2024, 37 out of the 55 Members of the African Union have either signed or ratified the treaty. [18]

Signatures


Ratification

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

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.

<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.

<span class="mw-page-title-main">European Medicines Agency</span> Agency of the European Union

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.

<span class="mw-page-title-main">Constitutive Act of the African Union</span> Treaty

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 safety, quality, efficacy and advertising in Australia of therapeutic goods. Therapeutic goods include goods that are represented to have a therapeutic effect, are included in a class of goods the sole or principal use of which is a therapeutic use, or are otherwise determined to be a therapeutic good through a legislative instrument under the Therapeutic Goods Act 1989. Goods that are therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG), or otherwise be the subject of an exemption, approval or authority by the TGA under the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 or Therapeutic Goods Regulations 2002 before they can be imported, supplied, exported or manufactured in Australia.

<span class="mw-page-title-main">African Economic Community</span> International organization

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.

<span class="mw-page-title-main">Healthcare in Iran</span>

For health issues in Iran see Health in Iran.

<span class="mw-page-title-main">European Directorate for the Quality of Medicines & HealthCare</span> International organisation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.

<span class="mw-page-title-main">African Union</span> Continental union of African states

The African Union (AU) is a continental union 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 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.

<span class="mw-page-title-main">Michel Sidibé</span>

Dr. Michel Sidibé is the African Union Special Envoy for the African Medicines Agency (AMA). He was the Minister of Health and Social Affairs of Mali. Sidibé was the second Executive Director of UNAIDS, serving from January 2009 until May 2019. He held the rank of Under-Secretary-General.

The Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health, also known as the MEDICRIME Convention, is an international criminal law convention, established by the Council of Europe. It focuses on combating the falsification of medicines and medical devices.

rVSV-ZEBOV vaccine Vaccine against Ebola virus disease

Recombinant vesicular stomatitis virus–Zaire Ebola virus (rVSV-ZEBOV), also known as Ebola Zaire vaccine live and sold under the brand name Ervebo, is an Ebola vaccine for adults that prevents Ebola caused by the Zaire ebolavirus. When used in ring vaccination, rVSV-ZEBOV has shown a high level of protection. Around half the people given the vaccine have mild to moderate adverse effects that include headache, fatigue, and muscle pain.

Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.

<span class="mw-page-title-main">African Continental Free Trade Area</span> Free trade area founded in 2018 with trade commencing as of 1 January 2021

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.

The International Coalition of Medicines Regulatory Authorities (ICMRA) is a global conference of government health bureaucrats.

<span class="mw-page-title-main">Africa Centres for Disease Control and Prevention</span> Public health agency of the African Union

The Africa Centres for Disease Control and Prevention is a public health agency of the African Union to support the public health initiatives of member states and strengthen the capacity of their health institutions to deal with disease threats. The idea of an African CDC was proposed by the government of Ethiopia in 2013, during a TB/HIV special summit in Abuja, Nigeria. From 2013 to 2016, the modalities and statute of Africa CDC were developed, and the specialized agency was officially launched in January 2017.

<span class="mw-page-title-main">National Health Regulatory Authority (Bahrain)</span>

The National Health Regulatory Authority (NHRA) is an independent regulatory body established in 2010, under Law No. 38 of 2009, of the Kingdom of Bahrain.

References

  1. ↑ "African Medicines Agency Will Come into Being on 5 November – after 15th African Country Ratifies & Deposits AMA Treaty". Health Policy Watch. 6 October 2021. Retrieved 9 November 2022.
  2. ↑ "African Union Selects Rwanda to Host African Medicines Agency, Grants Africa CDC Autonomous Status". Health Policy Watch. 18 July 2022. Retrieved 9 November 2022.
  3. 1 2 3 4 5 Anderson, Tatum (3 July 2017). "Enter The African Medicines Agency, Continent's First Super-Regulator?". Intellectual Property Watch. Retrieved 8 July 2020.
  4. 1 2 3 4 5 6 Ndomondo-Sigonda, Margareth; Miot, Jacqueline; Naidoo, Shan; Dodoo, Alexander; Kaale, Eliangiringa (3 November 2017). "Medicines Regulation in Africa: Current State and Opportunities". Pharmaceutical Medicine. 31 (6): 383–397. doi: 10.1007/s40290-017-0210-x . PMC   5691122 . PMID   29200865.
  5. 1 2 "Interview "We are moving towards regional and even continental regulation with the African Medicines Agency"". Africa News Agency. 17 May 2018. Retrieved 8 July 2020.
  6. ↑ Klock, Kevin A.; Gostin, Lawrence O.; Halabi, Sam F. (November 25, 2021). "Going Global, Acting Local: How an International Pandemic Convention Can Support Regional and Community Response Convention Can Support Regional and Community Response". Africa Health Journal . SSRN   3976972.
  7. 1 2 3 4 5 National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Global Health; Committee on Stronger Food and Drug Regulatory Systems Abroad (9 April 2020). Stronger Food and Drug Regulatory Systems Abroad. National Academies Press. pp. 61–. ISBN   978-0-309-67043-2.{{cite book}}: CS1 maint: multiple names: authors list (link)
  8. 1 2 Tjitemisa, Kuzeeko (25 June 2020). "MPs welcome continental medicine body". New Era Newspaper. Retrieved 8 July 2020.
  9. 1 2 3 Jerving, Sarah (7 July 2020). "African Union needs more country support to launch the African Medicines Agency". Devex. Retrieved 8 July 2020.
  10. 1 2 3 4 5 6 "African Medicine Agency (AMA) Treaty". African Union. 5 February 2020. Retrieved 8 July 2020.
  11. 1 2 3 Mu Xuequan, ed. (5 August 2019). "African countries urged to ratify continental medicine treaty". Xinhua. Archived from the original on August 4, 2019. Retrieved 8 July 2020.
  12. 1 2 Africa Press Office (21 April 2020). "Gabon Republic signs Treaty for the Establishment of the African Medicine Agency (AMA)". CNBC Africa. Retrieved 8 July 2020.
  13. 1 2 3 Kamau, Pie (10 February 2020). "Guinea, Seychelles and Niger sign Treaty for establishment of African Medicines Agency". Africa Business Communities. Retrieved 8 July 2020.
  14. ↑ "PAP Acknowledges Gabon; calls for ratification of the African Medicines Agency Treaty (AMAT)". Pan African Parliament. Retrieved 8 July 2020.
  15. ↑ Isilow, Hassan (17 June 2020). "Africa launches medical supplies platform for COVID-19". Anadolu Agency. Retrieved 8 July 2020.
  16. ↑ Sithole, Tariro; Mahlangu, Gugu; Salek, Sam; Walker, Stuart (29 April 2020). "Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration Initiative". Therapeutic Innovation & Regulatory Science. 54 (6): 1319–1329. doi: 10.1007/s43441-020-00154-y . PMC   7704514 . PMID   33258094.
  17. ↑ Dansie, Live Storehagen; Odoch, Walter Denis; Årdal, Christine (19 June 2019). "Industrial perceptions of medicines regulatory harmonization in the East African Community". PLOS ONE. 14 (6): e0218617. Bibcode:2019PLoSO..1418617D. doi: 10.1371/journal.pone.0218617 . PMC   6583972 . PMID   31216323.
  18. ↑ "African Medicines Agency Countdown". Health Policy Watch. Collaboration with the African Medicines Agency Treaty Alliance. Retrieved 2024-11-17.
  19. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 "List of countries which have signed, ratified/acceded to the treaty for the establishment of the African Medicines Agency" (PDF). African Union. Retrieved 8 July 2020.
  20. ↑ "The Sahrawi Arab Democratic Republic signs the Treaty for the Establishment of the African Medicines Agency". African Union. 7 July 2019. Retrieved 8 July 2020.
  21. ↑ "The People's Democratic Republic of Algeria signs the Treaty for the establishment of the African Medicines Agency". African Union. 7 July 2019. Retrieved 8 July 2020.
  22. ↑ Kamau, Pie (29 January 2020). "Chad signs Treaty for establishment of African Medicine Agency". Africa Business Communities. Retrieved 8 July 2020.
  23. ↑ "Seychelles signs the African Medicine Agency (AMA) Treaty". Department of Foreign Affairs. 10 February 2020. Retrieved 8 July 2020.
  24. ↑ Africa Press Office (11 June 2020). "The Republic of Mali ratifies the Treaty for the establishment of the African Medicine Agency (AMA)". CNBC Africa. Retrieved 8 July 2020.
  25. ↑ Hatim, Yahia (6 July 2020). "King Mohammed VI Approves New Military Laws, International Agreements". Morocco World News. Retrieved 8 July 2020.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.