Regulatory Lifecycle Management of Solid Oral Dosage Forms in Nigeria and Kenya

  • Shreya Kumar K.B.Institute of pharmaceutical education and research
  • Zuki Patel Department of Pharmaceutical Regulatory Affairs, K. B. Institute of Pharmaceutical Education and Research, A constituent college of Kadi Sarva Vishwavidyalaya, Gate No 1, Kadi Campus Rd, Sector 23, Gandhinagar, Gujarat 382016
  • Niranjan Kanaki Department of Pharmaceutical Regulatory Affairs, K. B. Institute of Pharmaceutical Education and Research, A constituent college of Kadi Sarva Vishwavidyalaya, Gate No 1, Kadi Campus Rd, Sector 23, Gandhinagar, Gujarat 382016
  • Maitreyi Zaveri Department of Pharmaceutical Regulatory Affairs, K. B. Institute of Pharmaceutical Education and Research, A constituent college of Kadi Sarva Vishwavidyalaya, Gate No 1, Kadi Campus Rd, Sector 23, Gandhinagar, Gujarat 382016
  • Shruti Kharidia Inspiron regtech LLP, Ahmedabad, Gujarat, 380006
  • Vinit Movaliya Department of Pharmaceutical Regulatory Affairs, K. B. Institute of Pharmaceutical Education and Research, A constituent college of Kadi Sarva Vishwavidyalaya, Gate No 1, Kadi Campus Rd, Sector 23, Gandhinagar, Gujarat 382016
DOI https://doi.org/10.22270/ijdra.v14i2.885

Abstract

Solid oral dosage forms (SODFs), including tablets and capsules, are the most commonly used pharmaceutical products worldwide, requiring effective regulatory oversight throughout their lifecycle to ensure quality, safety, and efficacy. This review compares the regulatory lifecycle management frameworks for SODFs in Nigeria and Kenya, focusing on pre-market authorization, post-approval variation management, pharmacovigilance, and marketing authorization renewal. Drawing on regulatory guidelines, legislative frameworks, and relevant literature, the review finds that both Nigeria’s NAFDAC and Kenya’s PPB have adopted internationally aligned regulatory approaches, including CTD-based submissions, GMP inspections, and post-marketing surveillance systems. Despite progress in regulatory maturity and regional harmonization efforts, challenges such as limited resources, regulatory backlogs, and underreporting of adverse drug reactions remain. The experiences of both countries provide valuable insights for strengthening regulatory systems and supporting effective medicine lifecycle management across Africa.


Conclusion: Nigeria and Kenya have made significant progress in aligning SODF regulatory practices with international standards across the product life cycle. However, challenges in implementation particularly in Nigeria persist while on going regional harmonization efforts present promising opportunity to strengthen regulatory efficiency and consistency in sub–Saharan Africa.

Keywords: Solid oral dosage forms (SODFs), Regulatory lifecycle management, National Agency for Food and Drug Administration and Control (NAFDAC), Pharmacy and Poisons Board (PPB), Post-approval variations, Pharmacovigilance, Good Manufacturing Practice (GMP), African Medicines Regulatory Harmonization (AMRH), Regulatory convergence, Sub-Saharan Africa

Downloads

Download data is not yet available.

References

1. Pharmacy and Poisons Board (PPB). Pharmacy and poisons (registration of health products and technologies) rules. Nairobi: PPB; 2022 [Internet]. [cited 2026 Mar 24]. Available from:
https://web.pharmacyboardkenya.org/download/pharmacy-and-poisons-registration-of-health-products-and-technologies-rules-2022
2. Ndomondo-Sigonda M, Miot J, Naidoo S, Dodoo A, Kaale E. Medicines regulation in Africa: current state and opportunities. Pharm Med. [Internet]. 2017 [cited 2026 Mar 24];31:383–397. Available from:
https://doi.org/10.1007/s40290-017-0210-x
3. Ncube BM, Dube A, Ward K. Establishment of the African Medicines Agency: progress, challenges and regulatory readiness. J Pharm Policy Pract. [Internet]. 2021 [cited 2026 Mar 24];14:25. Available from:
https://doi.org/10.1186/s40545-020-00281-9
4. National Agency for Food and Drug Administration and Control (NAFDAC). Guidelines for registration of pharmaceutical products in Nigeria. [Internet]. Abuja: NAFDAC; 2024 [cited 2026 Mar 24].Available from:
https://nafdac.gov.ng/regulatory-resources/guidelines/
5. World Health Organization. WHO global benchmarking tool (GBT) for evaluation of national regulatory systems. [Internet]. Geneva: WHO; 2023 [cited 2026 Mar 24]. Available from:
https://www.who.int/publications/i/item/9789240087637
6. National Agency for Food and Drug Administration and Control (NAFDAC). Pharmacovigilance and post-market surveillance regulations. [Internet]. Abuja: NAFDAC; 2023 [cited 2026 Mar 24]. Available from:
https://nafdac.gov.ng/our-services/pharmacovigilance-post-market-surveillance/
7. World Health Organization. Good regulatory practices: guidelines for national regulatory authorities for medical products. [Internet].Geneva: WHO; 2021 [cited 2026 Mar 24]. Available from:
https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/guidelines/regulatory-standard
Statistics
41 Views | 42 Downloads
How to Cite
1.
Kumar S, Patel Z, Kanaki N, Zaveri M, Kharidia S, Movaliya V. Regulatory Lifecycle Management of Solid Oral Dosage Forms in Nigeria and Kenya. Int J Drug Reg Affairs [Internet]. 2026Jun.15 [cited 2026Jul.10];14(2):45-8. Available from: https://www.ijdra.com/index.php/journal/article/view/885
Issue
Vol 14 No 2 (2026): VOLUME 14, ISSUE 2, 2026
Section
Review
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.

I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.

Download link for COPYRIGHT FORM

 

Most read articles by the same author(s)