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

English version

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: https://doi.org/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/.

Článek Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

Článek A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative

Článek Optimizing the East African Community’s Medicines Regulatory Harmonization initiative in 2020–2022: A Roadmap for the Future

Článek A gender-sensitised weight-loss and healthy living program for men with overweight and obesity in Australian Football League settings (Aussie-FIT): A pilot randomised controlled trial

Článek Incidence of and trends in hip fracture among adults in urban China: A nationwide retrospective cohort study

Článek Ambient air pollution and cause-specific risk of hospital admission in China: A nationwide time-series study

Článek A multiphase program for malaria elimination in southern Mozambique (the Magude project): A before-after study

Článek Development and validation of a model for predicting incident type 2 diabetes using quantitative clinical data and a Bayesian logistic model: A nationwide cohort and modeling study

Článek Health screening results of Cubans settling in Texas, USA, 2010–2015: A cross-sectional analysis

Článek Relative contribution of diet and physical activity to increased adiposity among rural to urban migrants in India: A cross-sectional study

Článek Temporal variations in the distribution of self-harm episodes and methods across the Australian asylum seeker population: An observational study