A quality regulatory system is a critical tool in protecting public health against the unauthorized flow and use of medical products in any country. This review summarizes the current status of National Medicines Regulatory Authorities (NMRAs) in Africa and various requirements that have been established to evaluate the registration procedures in the continent. The regulatory strategy during the product development is essential before the commencement of developmental work in order to avoid major surprises after the submission of the application. The quality, safety, and efficacy of all medicines in the respective country are regulated by the regulatory authorities. All countries in Africa (except the Sahrawi Republic), have NMRAs but their organizational setup and functionality vary. Some are located within Ministries of Health while others are semi-autonomous. With 70% to 90% of the drugs in the African continent still following the import route, strengthening the regulatory framework has been a key focus area. The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories, and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities over the years. Accordingly, there is progressive improvement in a regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance, and clinical trials oversight. However, with changing dynamics of the health conditions wherein Africa is struggling with both infectious diseases and non-communicable chronic diseases, multinational pharmaceutical companies are targeting to accelerate access to medicines, approved globally, to Africa. The paper here aims to guide international pharmaceutical companies who would like to leverage approval in other markets for faster approvals in the African continent.

References

1. Wikipedia contributors. Africa [Internet]. Wikipedia, The Free Encyclopedia. Available from:  https://en.wikipedia.org/wiki/South_African_Health_Products_Regulatory_Authority
2. Roser M, Ritchie H. Burden of disease. Our World in Data [Internet]. 2016 [cited 2021 Sep 21]; Available from: https://ourworldindata.org/burden-of-disease
3. Kappelle M. State of the climate in Africa 2019. World Meteorological Organization; 2020. https://library.wmo.int/doc_num.php?explnum_id=10421
4. Holt T, Lahrichi M, da Silva JS. Africa: A continent of opportunity for pharma and patients [Internet]. Mckinsey.com. McKinsey & Company; 2015 [cited 2021 Sep 21]. Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/africa-a-continent-of-opportunity-for-pharma-and-patients
5. Differentiate and Win in The African Pharma Market [Internet]. Iqvia.com. [cited 2021 Sep 21]. Available from: https://www.iqvia.com/locations/middle-east-and-africa/library/white-papers/differentiate-and-win-in-the-african-pharma-market
6. Roth L, Bempong D, Babigumira JB, Banoo S, Cooke E, Jeffreys D, et al. Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems. Global Health. 2018;14(1):102. https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-018-0421-2
7. Doua JY, Van Geertruyden J-P. Registering medicines for low-income countries: how suitable are the stringent review procedures of the World Health Organisation, the US Food and Drug Administration and the European Medicines Agency? Trop Med Int Health. 2014;19(1):23–36. https://pubmed.ncbi.nlm.nih.gov/24134396/
8. Narsai K, Leufkens HGM, Mantel-Teeuwisse AK. Linking market authorizations of medicines with disease burden in South Africa. J Pharm Policy Pract. 2021;14(1):33.
9. African Pharmaceutical Market Analysis By Therapeutic Class , By Drug Categories, By Inhalants, By Anabolic Steroids & by Region With COVID-19 impact; | Forecast Period 2019-2035 Published Date : 2021-05-18 https://www.goldsteinresearch.com/report/africa-pharmaceutical-industry-market-size-forecast
10. Kesselheim, Aaron S et al. “Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.” Drugs vol. 75,6 (2015): 633-50. doi:10.1007/s40265-015-0382-1
11. Center for Drug Evaluation, Research. Generic drug development [Internet]. Fda.gov. 2021 [cited 2021 Sep 21]. Available from: https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drug-development
12. Chen, Mei-Ling et al. “Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.” European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences vol. 44,4 (2011): 506-13. doi:10.1016/j.ejps.2011.09.010
13. Chen, Mei-Ling et al. “The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.” European journal of pharmaceutical sciences: official journal of the European Federation for Pharmaceutical Sciences vol. 111 (2018): 153-157. doi:10.1016/j.ejps.2017.09.047
14. EDA Egypt ???? ?????? ??????? [Internet]. Gov.eg. [cited 2021 Sep 21]. Available from: https://www.edaegypt.gov.eg/
15. Guideline for Stability Study of Imported Drug Substance and Drug Product for human and biological products submitted according to ministerial decree 820/2016 (CTD) https://www.edaegypt.gov.eg/media/x2hjm45y/guidelines-for-imported-stability-study-ctd_stability-head-edaeg.pdf
16. Keyter, Andrea et al. “South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access.” Frontiers in pharmacology vol. 12 699063. 23 Jul. 2021, doi:10.3389/fphar.2021.699063
17. SAHPRA - South African Health Products Regulatory Authority [Internet]. Org.za. 2020 [cited 2021 Sep 21]. Available from: https://www.sahpra.org.za/
18. 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.
19. 2.58         Submission guideline in eSubmission format https://www.sahpra.org.za/general-ectd-human-medicines-guidelines/
20. Clinical guideline by SAPHRA https://www.sahpra.org.za/wp-content/uploads/2020/02/2.09_Clinical-Guideline_Jul19_v2-1.pdf
21. Quality and Bioequivalence Guideline https://www.sahpra.org.za/wp-content/uploads/2020/02/2.02_Quality-and-Bioequivalence-Guideline_Jul19_v7-1.pdf
22. Bioequivalence Trial Information Form  by SAPHRA https://www.sahpra.org.za/wp-content/uploads/2020/09/BIOEQUIVALENCE-TRIAL-INFORMATION-FORM.pdf
23. General Information https://www.sahpra.org.za/wp-content/uploads/2020/01/2.01_General-information_-Jul19_v10.pdf
24. Guideline for Patient Information Leaflet For Human Medicines https://www.sahpra.org.za/wp-content/uploads/2020/02/2.14_Guideline-for-Patient-Information-Leaflet-for-Human-Medicines-Categories-A-and-D_Jul19_v2-1.pdf
25. Guideline for the API Master File (APIMF) Procedure Jan 2021 https://www.sahpra.org.za/wp-content/uploads/2021/03/2.59_Guideline-for-the-APIMF-Procedure_Jan2021_v2.pdf     SAHPRA Registered Health Productshttps://registered-health-products.sahpra.org.za/