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:
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 vyšel v časopise
PLOS Medicine
2020 Číslo 8
- Mikroplasty a jejich riziko pro zdraví: Co všechno víme?
- Vhodná dávka levothyroxinu u obézních pacientů s hypotyreózou
- Jak a kdy u celiakie začíná reakce na lepek? Možnou odpověď poodkryla čerstvá kanadská studie
- Prof. Jan Škrha: Metformin je bezpečný, ale je třeba jej bezpečně užívat a léčbu kontrolovat
- FDA varuje před selfmonitoringem cukru pomocí chytrých hodinek. Jak je to v Česku?
Nejčtenější v tomto čísle
- Social distancing to slow the US COVID-19 epidemic: Longitudinal pretest–posttest comparison group study
- Coming together to improve access to medicines: The genesis of the East African Community’s Medicines Regulatory Harmonization initiative
- Age and the association between apolipoprotein E genotype and Alzheimer disease: A cerebrospinal fluid biomarker–based case–control study
- A clinical algorithm for same-day HIV treatment initiation in settings with high TB symptom prevalence in South Africa: The SLATE II individually randomized clinical trial