Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative
Autoři:
Alexander R. Giaquinto aff001; Alberto Grignolo aff002; Lawrence Liberti aff003; John C. W. Lim aff004; Tomas Salmonson aff005; Fernand Sauer aff006; Henrietta Ukwu aff007
Působiště autorů:
ARG Consulting, LLC, United States of America
aff001; Parexel, Billerica, Massachusetts, United States of America
aff002; Centre for Innovation in Regulatory Science, London, United Kingdom
aff003; Centre of Regulatory Excellence, Duke—NUS Medical School, Singapore
aff004; Consilium Salmonson & Hemmings, Uppsala, Sweden
aff005; Académie Nationale de Pharmacie, Paris, France
aff006; Otsuka Pharmaceutical Companies, Princeton, New Jersey, United States of America
aff007
Vyšlo v časopise:
Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative. PLoS Med 17(8): e32767. doi:10.1371/journal.pmed.1003092
Kategorie:
Collection Review
doi:
https://doi.org/10.1371/journal.pmed.1003092
Souhrn
Alexander Giaquinto and co-authors discuss the East African Community's Medicines Regulatory Harmonization initiative.
Klíčová slova:
Africa – Drug regulation – Drug safety – European Union – Marketing – Public and occupational health – Regulations – Rheumatology
Zdroje
1. Ndomondo-Sigonda M, Mahlangu G, Agama-Anyetei M, Cooke E. A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative. PLoS Med. 2020;17(8): e1003099. doi: 10.1371/journal.pmed.1003099
2. 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
3. Mashingia JH, Ahonkhai V, Aineplan N, Ambali A, Angole A, Arik M, et al. Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned. PLoS Med. 2020;17(8): e1003134. doi: 10.1371/journal.pmed.1003134
4. 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
5. Bren L. Frances Oldham Kelsey. FDA medical reviewer leaves her mark on history. FDA Consum. 2001;35(2):24–9. 11444245
6. Office of Surveillance and Epidemiology (OSE) mission statement. US Food & Drug Administration website. 2019. Available from: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-surveillance-and-epidemiology-ose-divisions. [cited 2019 Dec 9].
7. Pharmacovigilance: Overview. European Medicines Agency website. 2019. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/pharmacovigilance-overview. [cited 2019 Dec 9].
8. Medicines approval system: Marketing authorisations for medicinal products within the EU. European Union Heads of Medicines Agencies website. 2019. Available from: https://www.hma.eu/medicinesapprovalsystem.html. [cited 2019 Sep 16].
9. CHMP: Working parties and other groups. European Medicines Agency website. 2019. Available from: https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups. [cited 2019 Sep 24].
10. European Medicines Agency (EMA) website. 2019. Available from: https://www.ema.europa.eu/en. [cited 2019 Aug 23].
11. 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
12. Foreign Corrupt Practices Act. US Department of Justice website. 2017. Available from: https://www.justice.gov/criminal-fraud/foreign-corrupt-practices-act. [cited 2019 Dec 9].
13. Sauer F. Pharmaceutical harmonisation in Europe and beyond. J Pharm Drug Devel. 2019;1(2).
14. Ukwu H. Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration. Boston, MA: CenterWatch; 2011.
15. Guidelines. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website. 2019. Available from: https://www.ich.org/products/guidelines.html. [cited 2019 Aug 23].
16. Medicines. European Medicines Agency (EMA) website. 2019. Available from: https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_medicine. [cited 2019 Aug 23].
17. Council of Europe. European Pharmacopoeia (9th ed.). Strasbourg: Council of Europe; 2015.
18. United States Pharmacopeia and National Formulary (USP 42-NF 37). Rockville, MD: United States Pharmacopeial Convention; 2019.
19. World Health Organization. Good Practices of National Regulatory Authorities in Implementing the Collaborative Registration Procedures for Medical Products. Working Document QAS/18.774. WHO website. 2018. Available from: http://origin.who.int/medicines/areas/quality_safety/quality_assurance/02_08_2018_qas18_774_good_practices_of_NRAs_implementing_CRP_clean.pdf. [cited 2019 Sep 9].
20. Mota C, Barbosa J, Liberti L, Bonamici D, Grignolo A. Expedited regulatory pathways in established and emerging markets. DIA Global Forum website. 2018. Available from: https://globalforum.diaglobal.org/issue/september-2018/expedited-regulatory-pathways-in-established-and-emerging-markets/. [cited 2019 Aug 23].
21. Keyter A, Salek S, Banoo S, Walker S. The South African Medicines Control Council: Comparison of its registration process with Australia, Canada, Singapore, and Switzerland. Front Pharmacol. 2019;10:228. doi: 10.3389/fphar.2019.00228 30923501
22. McAuslane N, Bujar M, Liberti L. Understanding the Dynamics of China’s Medicine Regulatory Environment. Centre for Innovation in Regulatory Science R&D Briefing 56. 2015.
23. Medicrime. Council of Europe website. 2019. Available from: https://www.coe.int/en/web/medicrime. [cited 2019 Sep 9].
24. Ndomondo-Sigonda M, Miot J, Naidoo S, Ambal A, Dodoo A, Mkandawire H. The African Medicines Regulatory Harmonization initiative: Progress to date. Medical Res Arch. 2018;6(2).
25. Ndomondo-Sigonda M, Agama-Anyetei M, Mahlangu G, Mkandawire H. African Medicines Agency Establishment Treaty adopted by African Ministers of Health. DIA Global Forum website. 2018. Available from: https://globalforum.diaglobal.org/issue/july-2018/african-medicines-agency-establishment-treaty-adopted-by-african-ministers-of-health/. [cited 2019 May 30].
Článek vyšel v časopise
PLOS Medicine
2020 Číslo 8
- S diagnostikou Parkinsonovy nemoci může nově pomoci AI nástroj pro hodnocení mrkacího reflexu
- Proč při poslechu některé muziky prostě musíme tančit?
- Chůze do schodů pomáhá prodloužit život a vyhnout se srdečním chorobám
- „Jednohubky“ z klinického výzkumu – 2024/44
- Je libo čepici místo mozkového implantátu?
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
