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


Autoři: Mawien Arik aff001;  Emmanuel Bamenyekanye aff002;  Adam Fimbo aff003;  Joseph Kabatende aff004;  Agnes Sitta Kijo aff003;  Burhani Simai aff005;  Fred Siyoi aff006;  Samvel Azatyan aff007;  Aggrey Ambali aff008;  Emer Cooke aff007;  Jane H. Mashingia aff009;  John Patrick Mwesigye aff009;  Margareth Ndomondo-Sigonda aff008;  Hiiti Sillo aff007;  Stanley Sonoiya aff009;  Paul Tanui aff008;  Mike Ward aff007;  Thomas Delano aff010
Působiště autorů: Drug and Food Control Authority, Juba, South Sudan aff001;  Directorate of Pharmacy, Medicines, and Laboratories, Bujumbura, Burundi aff002;  Tanzania Medicines and Medical Devices Authority, Dar Es Salaam, Tanzania aff003;  Rwanda Food and Drugs Authority, Kigali, Rwanda aff004;  Zanzibar Food and Drug Agency, Zanzibar City, Zanzibar aff005;  Pharmacy and Poisons Board, Nairobi, Kenya aff006;  World Health Organization, Geneva, Switzerland aff007;  African Union Development Agency–New Partnership for Africa’s Development, Midrand, South Africa aff008;  East African Community Secretariat, Arusha, Tanzania aff009;  Boston Consulting Group, Paris, France aff010
Vyšlo v časopise: Optimizing the East African Community’s Medicines Regulatory Harmonization initiative in 2020–2022: A Roadmap for the Future. PLoS Med 17(8): e32767. doi:10.1371/journal.pmed.1003129
Kategorie: Collection Review
doi: https://doi.org/10.1371/journal.pmed.1003129

Souhrn

Margareth Ndomondo-Sigonda outlines future challenges for the East African Medicines Regulatory Harmonization initiative.

Klíčová slova:

Africa – Drug regulation – Drug safety – HIV vaccines – Marketing – Medical devices and equipment – Rheumatology – Tanzania


Zdroje

1. McEwen J. Artesunate- and amodiaquine-associated extrapyramidal reactions: a series of 49 cases in VigiBase. Drug Saf. 2012;35(8):667–75. doi: 10.1007/BF03261963 22788236

2. Bompart F. Artesunate- and amodiaquine-associated extrapyramidal reactions: information gained from an African-based risk management plan. Drug Saf. 2013;36(1):71–2. doi: 10.1007/s40264-012-0010-x 23315298

3. World Bank. World development indicators: Classifying countries by income. World Bank website. 2018 [cited 2019 May 30]. http://datatopics.worldbank.org/world-development-indicators/stories/the-classification-of-countries-by-income.html

4. Wirtz VJ, Hogerzeil HV, Gray AL, Bigdeli M, de Joncheere CP, Ewen MA, et al. Essential medicines for universal health coverage. Lancet. 2017;389(10067):403–76. doi: 10.1016/S0140-6736(16)31599-9 27832874

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

6. 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

7. Brochure: East African Community Medicines Regulatory Harmonization (EAC MRH) Programme: Joint Regulatory Procedures. East African Community’s Medicines Regulatory Harmonization initiative website. 2019 [cited 2019 Sep 23]. https://www.tmda.go.tz/uploads/publications/en1594208729-%20EAC%20JOINT%20REGULATORY%20PROCEDURES-%20JUNE%202020%20(2).pdf

8. 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

9. Bassat Q, Tanner M, Guerin PJ, Stricker K, Hamed K. Combating poor-quality anti-malarial medicines: a call to action. Malar J. 2016;15:302. doi: 10.1186/s12936-016-1357-8 27251199

10. Eligibility Criteria for WHO Prequalification of In Vitro Diagnostics. Version 4. Geneva: World Health Organization, 2019.

11. Sinha M, Jupe J, Mack H, Coleman TP, Lawrence SM, Fraley SI. Emerging technologies for molecular diagnosis of sepsis. Clin Microbiol Rev. 2018;31(2). doi: 10.1128/cmr.00089-17 29490932

12. Pedram B, Pasquetto V, Drame PM, Ji Y, Gonzalez-Moa MJ, Baldwin RK, et al. A novel rapid test for detecting antibody responses to Loa loa infections. PLoS Negl Trop Dis. 2017;11(7):e0005741. doi: 10.1371/journal.pntd.0005741 28749939

13. Prequalification of vaccines. World Health Organization website. 2019 [cited 2019 May 30]. https://www.who.int/immunization_standards/vaccine_quality/vq_index/en/

14. WHO kick-starts pilot prequalification of biotherapeutics for cancer treatment. World Health Organization website. 2018 [cited 2019 May 30]. https://extranet.who.int/prequal/news/who-kick-starts-pilot-prequalification-biotherapeutics-cancer-treatment

15. Reproductive health essential medicines: prequalification. World Health Organization website. 2019 [cited 2019 May 30]. https://www.who.int/rhem/prequalification/en/

16. Vaccine quality: Performance, quality, and safety catalogue. World Health Organization website. 2019 [cited 2019 May 30]. http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/index.aspx

17. Pan African Harmonisation Working Party on Medical Devices and Diagnostics. PAHWP website. 2019 [cited 2019 May 30]. http://www.pahwp.org/

18. ClinicalTrials.gov. 2019 [cited 2019 Jun 14]. https://clinicaltrials.gov/

19. Akanmori B, Mukanga D, Bellah A, Traore T, Ward M, Mihigo R. The role of the African Vaccine Regulatory Forum (AVAREF) in the accelerated clinical evaluation of ebola virus vaccine candidates during the large West Africa epidemic. J Immunol Sci. 2018;S(011):75–9.

20. Mukanga D. Harmonized tools for clinical trial regulation in Africa: AVAREF update based on 2018–2020 strategic plan. DIA Global Forum website. 2018 [cited 2019 May 30]. https://globalforum.diaglobal.org/issue/december-2018/harmonized-tools-for-clinical-trial-regulation-in-africa-are-imminent/

21. ICH Harmonised Guideline: General Principles for Planning and Design of Multi-Regional Clinical Trials, E17. United States Food and Drug Administration website. 2018 [cited 2019 Jun 14]. https://www.fda.gov/media/99974/download

22. 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

23. Agyepong IA, Sewankambo N, Binagwaho A, Coll-Seck AM, Corrah T, Ezeh A, et al. The path to longer and healthier lives for all Africans by 2030: the Lancet Commission on the future of health in sub-Saharan Africa. Lancet. 2018;390(10114):2803–59. doi: 10.1016/S0140-6736(17)31509-X 28917958

24. WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. World Health Organization website. 2017 [cited 2019 Sep 23]. https://www.who.int/medicines/regulation/ssffc/publications/gsms-report-sf/en/

25. EAC Pilot Post Market Surveillance Report: Monitoring the Quality of Selected Antibiotics in EAC Partner States. Arusha, Tanzania: EAC Secretariat, 2019.

26. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems. World Health Organization website. 2019 [cited 2019 May 30]. https://www.who.int/medicines/regulation/benchmarking_tool/en/

27. Lions Head Global Partners. Final Report: Develop a Sustainable Financing Model for National Medicines Regulatory Agencies in the East African Community. East African Community’s Medicines Regulatory Harmonization initiative website. 2016 [cited 2019 Sep 23]. https://www.tmda.go.tz/uploads/publications/en1594215401-Lions%20Head%20Global%20Partners.%20Final%20Report-%20Develop%20a%20Sustainable%20Financing%20Model%20for%20National%20Medicines%20Regulatory%20Agencies%20in%20the%20East%20African%20Community..pdf


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