From Policy to Practice: Evaluating the Impact of Regulatory Reforms on Nigeria’s Local Pharmaceutical Industry.
Abstract:
This article evaluates how Nigeria’s recent
regulatory reforms have translated from policy to practice within the local
pharmaceutical manufacturing sector following attainment of WHO Global
Benchmarking Tool Maturity Level 3. A descriptive cross-sectional survey of
NAFDAC-licensed manufacturers engaged in production, quality assurance, and
regulatory affairs was conducted to assess awareness, adoption, and perceived
effects of core reforms—Good Manufacturing Practice (GMP), Quality Management
Systems (QMS), and digital platforms such as the NAFDAC Automated Product
Administration and Monitoring System (NAPAMS) and the Ports Inspection Data
Capture and Risk Management System (PIDCARMS). The questionnaire, aligned to
WHO-GBT indicators and demonstrating strong internal consistency (Cronbach’s
α = 0.82), comprised multiple-choice, Likert-scale, and open-ended items.
Descriptive results showed high awareness and uptake of WHO-GMP (87.7%) and
substantial engagement with NAPAMS (70.5%), but comparatively lower adoption of
PIDCARMS (47.5%). Principal Component Analysis identified two latent
dimensions: (i) optimism that reforms improve internal quality and operational
outcomes, and (ii) tension between firms’ confidence in compliance capacity and
scepticism about the consistency of external enforcement. Reported barriers
included the financial burden of GMP upgrades, uneven digital infrastructure,
and user capacity constraints. Respondents credited reforms with strengthening
compliance culture and improving product quality but cautioned that
process-based milestones do not automatically yield market-level gains.
Realising full public health and industrial benefits will require targeted SME
support, phased implementation, transparent oversight, and sustained investment
in digital readiness and outcome monitoring.
References:
[1]. Akinyandenu, O., 2013, Counterfeit drugs in Nigeria: A threat to public health. African Journal of Pharmacy and Pharmacology, 7(36), 2571–2576. https://doi.org/10.5897/AJPP12.343
[2]. Akunne, O. O., Mbamalu, O., Eze, S. C., & Fadare, J. O., 2025, Insight into Nigeria’s pharmacovigilance landscape: stakeholder perspectives on strengthening medicine safety systems. Discover Health Systems, 4, Article 52. https://doi.org/10.1007/s44250-025-00234-6
[3]. Anyakora, C., Ekwunife, O., Alozie, F., Esuga, M., Ukwuru, J., Onya, S., & Nwokike, J., 2017, Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre and post certification of a Nigerian pharmaceutical manufacturer. BMC Health Services Research, 17(1), 665. https://doi.org/10.1186/s12913-017-2610-8
[4]. AUDA NEPAD, 2022, African Medicines Regulatory Harmonization Programme: Strategic Plan 2022–2026. Retrieved July 20, 2025, from https://www.nepad.org/publication/amrh-strategic-plan-2022-2026
[5]. Bigdeli, M., Peters, D. H., & Wagner, A. K., 2020, Medicines in health systems: Advancing access, affordability and appropriate use. Geneva: World Health Organization. Retrieved July 20, 2025, from https://www.who.int/alliance-hpsr/resources/flagshipreports/en/index1.html
[6]. Ensor, T., & Weinzierl, S., 2007, Regulating health care in low and middle income countries: Broadening the policy response in resource constrained environments. Social Science & Medicine, 65(2), 355–366. https://doi.org/10.1016/j.socscimed.2007.03.021 researchgate.net+2researchgate.net+2academic.oup.com+2ccpsh.org+6pubmed.ncbi.nlm.nih.gov+6ideas.repec.org+6
[7]. Mackintosh, M., Banda, G., Wamae, W., & Tibandebage, P., 2018, Making medicines in Africa: The political economy of industrializing for local health. London: Palgrave Macmillan.
[8]. Mukherjee, S., & Goodman, C., 2023, Strengthening regulatory systems in LMICs: Lessons from COVID 19 and beyond. Health Policy and Planning, 38(3), 379–388. https://doi.org/10.1093/heapol/czad008
[9]. National Agency for Food and Drug Administration and Control. 2022, Guidelines for clearing of imported donated items through PIDCARMS [PDF]. Retrieved from https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/PORTINSPECTION_GUIDELINES/2022_To_2027/Guidelines-for-Clearing-of-Imported-Donated-Items-in-Nigeria.pdf Healthy DEvelopments+3NAFDAC+3NAFDAC+3NAFDAC+2NAFDAC+2Texila Journal+2
[10]. Okoduwa, S. I. R., Obu, D. C., Idoko, D. O., & Daniel, C., 2025, The effect of logistics management on the performance of small and medium pharmaceutical companies in Southern Nigeria. Pharmaceutical Society of Nigeria Nigerian Journal of Pharmacy, 59(1), 80–90. https://www.psnnjp.org/index.php/home/article/view/588
[11]. Oluwafemi, T., & Adeyemo, O., 2021, Exploring regulatory fragmentation in Nigeria’s pharmaceutical supply chain. Pan African Medical Journal, 38, 251. https://doi.org/10.11604/pamj.2021.38.251.28788
[12]. Organisation for Economic Co operation and Development. 2021, The digital transformation of SMEs (OECD Studies on SMEs and Entrepreneurship). Paris: OECD Publishing. Retrieved from https://www.oecd.org/industry/smes/The-digital-transformation-of-SMEs.pdf
[13]. Pisani, E., Nistor, A. L., Hasnida, A., Parmaksiz, K., Xu, J., & Salvage, L., 2019, Identifying market risk for substandard and falsified medicines: An analytic framework based on qualitative research in China, Indonesia, Turkey and Romania. Wellcome Open Research, 4, 70. https://doi.org/10.12688/wellcomeopenres.15236.1
[14]. United Nations Industrial Development Organization. 2021, Good regulatory practice and quality infrastructure in pharmaceutical manufacturing. Vienna: UNIDO. Retrieved July 20, 2025, from https://www.unido.org/sites/default/files/2016-05/UNIDO_Quality_system_0.pdf unido.org
[15]. Wirtz, V. J., Hogerzeil, H. V., Gray, A. L., Bigdeli, M., de Joncheere, C. P., Ewen, M. A., Reich, M. R., 2017, Essential medicines for universal health coverage. The Lancet, 389(10067), 403–476. https://doi.org/10.1016/S0140-6736(16)31599-9 thelancet.com+3
[16]. World Health Organization. 2021, Global Benchmarking Tool (GBT) for evaluation of national regulatory systems of medical products: Revision VI. Geneva: WHO. Retrieved from https://www.who.int/publications/i/item/9789240020245
[17]. World Health Organization. 2022, March 30. Egypt and Nigeria medicines regulators achieve high maturity level in WHO classification and WHO launches list of regulatory authorities that meet international standards [News release]. WHO. cdn.who.int+13who.int+13pmc.ncbi.nlm.nih.gov+13nafdac.gov.ng+4instagram.com+4wahooas.org+4
[18]. World Health Organization. 2023a, Ecosystem for local production of essential medicines in Nigeria: A WHO-supported case study. Geneva: WHO. Retrieved from https://iris.who.int/handle/10665/376688
[19]. World Health Organization. 2023b, Regulation and Prequalification Department impact assessment (RPQ Impact Assessment Report). Geneva: WHO. Retrieved July 20, 2025, from https://cdn.who.int/media/docs/default-source/medicines/regulatory-updates/rpq/who-rpq-impact-assessment-report_2023.pdf
[20]. World Health Organization. 2023c, TRS 1033 – Annex 11: Good regulatory practices in the regulation of medical products. Geneva: WHO. Retrieved from https://www.who.int/publications/m/item/annex-11-trs-1033 World Health Organization
[21]. World Health Organization. 2024, December 3. Substandard and falsified medical products [Fact sheet]. Retrieved July 20, 2025, from https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
