Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned


Autoři: Jane H. Mashingia aff001;  Vincent Ahonkhai aff002;  Noel Aineplan aff003;  Aggrey Ambali aff004;  Apollo Angole aff003;  Mawien Arik aff005;  Samvel Azatyan aff006;  Peter Baak aff005;  Emmanuel Bamenyekanye aff007;  Aimable Bizoza aff008;  Chimwemwe Chamdimba aff004;  Petra Doerr aff009;  Adam Fimbo aff010;  Alex Gisagara aff008;  Hidaya Hamad aff011;  Rachelle Harris aff012;  Dan Hartman aff013;  Joseph Kabatende aff008;  Charles Karangwa aff008;  Agnes Sitta Kijo aff010;  Murray Lumpkin aff013;  Shani Maboko aff010;  David Matle aff010;  Apollo Muhairwe aff014;  John Patrick Mwesigye aff001;  Bonaventure Nyabenda aff007;  Alexander Schulze aff015;  Andreas Seiter aff014;  Gordon Sematiko aff003;  Margareth Sigonda aff004;  Hiiti Sillo aff006;  Burhani Simai aff011;  Fred Siyoi aff016;  Stanley Sonoiya aff001;  Paul Tanui aff004;  Mike Ward aff006;  Felistas Yano aff016;  David Mukanga aff013
Působiště autorů: East African Community Secretariat, Arusha, Tanzania aff001;  Gwynedd Consultancy, LLC, Philadelphia, Pennsylvania, United States of America aff002;  National Drug Authority, Kampala, Uganda aff003;  African Union Development Agency–New Partnership for Africa’s Development, Midrand, South Africa aff004;  Drug and Food Control Authority, Juba, South Sudan aff005;  World Health Organization, Geneva, Switzerland aff006;  Directorate of Pharmacy, Medicines, and Laboratories, Bujumbura, Burundi aff007;  Rwanda Food & Drugs Authority, Kigali, Rwanda aff008;  Petra Doerr Consulting Ltd., Herznach, Switzerland aff009;  Tanzania Medicines and Medical Devices Authority, Dar Es Salaam, Tanzania aff010;  Zanzibar Food & Drug Agency, Zanzibar City, Zanzibar aff011;  Harris Access Consulting Ltd, London, United Kingdom aff012;  Bill & Melinda Gates Foundation, Seattle, Washington, United States of America aff013;  World Bank, Washington DC, United States of America aff014;  Swiss Agency for Development and Cooperation, Bern, Switzerland aff015;  Pharmacy & Poisons Board, Nairobi, Kenya aff016
Vyšlo v časopise: Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned. PLoS Med 17(8): e32767. doi:10.1371/journal.pmed.1003134
Kategorie: Collection Review
doi: 10.1371/journal.pmed.1003134

Souhrn

Jane H. Mashingia and colleagues reveal the progress made to date for the East African Community Medicines Regulatory Harmonization initiative.

Klíčová slova:

Burundi – Drug regulation – Drug safety – Kenya – Oncology – Rheumatology – Rwanda – Tanzania


Zdroje

1. Assessing national medicines regulatory systems. World Health Organization website. 2020 [2020 cited Feb 24]. https://www.who.int/medicines/areas/quality_safety/regulation_legislation/assesment/en/.

2. Avastin approval history. 2019 [2019 cited Apr 22]. https://www.drugs.com/history/avastin.html

3. Herceptin approval history. 2019 [cited 2019 Apr 22]. https://www.drugs.com/history/herceptin.html

4. WHO Model List of Essential Medicines. 19th list. Geneva: World Health Organization, 2015.

5. Kamwanja L, Saka J, Awotedu A, Fute I, Chamdimba C, Ndomondo-Sigonda M. Situational Analysis Study on Medicines Registration Harmonisation in Africa: Final Report for the East African Community. NEPAD, 2010.

6. Sillo H, Ambali A, Azatyan S, Chamdimba C, Kaale E, Kabatende J, et al. Coming together to improve access to medicines: The genesis of the East African Community’s Medicines Regulatory Harmonization initiative. PLoS Med. 2020;17(8): e1003133. doi: 10.1371/journal.pmed.1003133

7. Boston Consulting Group. EAC Medicines Regulatory Harmonization Program: End-Term Evaluation. 2017.

8. Compendium of Medicines Evaluation and Registration for Medicine Regulation Harmonization in the East African Community. Document No: EAC/TF-MED/MER/FD/COM/N1R1. East African Community’s Medicines Regulatory Harmonization initiative website. 2019 [cited 2019 Sep 23]. https://www.tmda.go.tz/uploads/publications/en1583243476-eac%20compendium%20of%20guidelines%20on%20human%20medicines%20evaluation%20and%20registration.pdf

9. Dansie LS, Odoch WD, Ardal C. Industrial perceptions of medicines regulatory harmonization in the East African Community. PLoS ONE. 2019;14(6):e0218617. doi: 10.1371/journal.pone.0218617 31216323

10. Compendium of Good Manufacturing Practices (GMP) Technical Documents for Harmonization of Medicines Regulation in the East African Community. East African Community’s Medicines Regulatory Harmonization initiative website. 2014 [cited 2019 Sep 23]. https://www.tmda.go.tz/uploads/publications/en1547291375-GMP%20EAC%20Compendium.pdf

11. EAC Harmonized Compendium on Safety and Vigilance of Medical Products and Health Technologies. East African Community’s Medicines Regulatory Harmonization initiative website. 2019 [cited 2019 Sep 23]. https://www.tmda.go.tz/uploads/publications/en1594202820-PV%20COMPENDIUM%20VALIDATED%2018%2003%202019.pdf

12. Arik M, Bamenyekanye E, Fimbo A, Kabatende J, Kijo AS, Simai B, et al. Optimizing the East African Community’s Medicines Regulatory Harmonization initiative in 2020–2022: A Roadmap for the Future. PLoS Med. 2020;17(8): e1003129. doi: 10.1371/journal.pmed.1003129

13. Cooperation Framework Agreement for EAC Partner States National Medicines Regulatory Authorities. East African Community’s Medicines Regulatory Harmonization initiative website. 2018 [cited 2019 Sep 23]. https://www.tmda.go.tz/uploads/publications/en1594215479-Cooperation%20Framework%20Agreement%20for%20EAC%20Partner%20States%20National%20Medicines%20Regulatory%20Authorities.pdf

14. Regulatory system strengthening. World Health Organization website. 2019 [cited 2019 June 4]. https://www.who.int/medicines/regulation/rss/en/.


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PLOS Medicine


2020 Číslo 8

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