ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Assessment of compliance with Good Review Practices by Medicine Assessors within the Zambia Medicines Regulatory Authority.
Provisionally accepted
- 1University of the Witwatersrand, Johannesburg, South Africa
- 2Zambia Medicines Regulatory Authority, Lusaka, Zambia
- 3WITS Pharmacy Regulatory Science Hub Research Unit, Department of Pharmacy and Pharmacology, School of Therapeutic Sciences, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
- 4Centre for Innovation in Regulatory Science Limited, London, United Kingdom
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The implementation of Good Review Practices (GRevPs) ensures the timely, high-quality review and enhanced availability to safe, quality, and efficacious medicines. It is important, therefore, that all aspects of GRevPs are continuously updated and monitored to promote improvement of the review process. This study aimed to assess the implementation of the GRevPs in the Zambia Medicines Regulatory Authority (ZAMRA) to identify opportunities for improvement. The GRevP Questionnaire developed by the Centre for Innovation in Regulatory Science (CIRS), an established, structured and multi-dimensional questionnaire was completed by the scientific reviewers of the ZAMRA. Twelve of the 16 assessors took part in the study of whom 5 (42%) reported that GRevPs have been implemented and fully adopted across the agency. The study participants provided details indicating the reasons why they believe quality measures had been implemented within ZAMRA. The three most common reasons were to be more efficient, to improve process predictability and increase transparency. However, most of the respondents believed that the current GRevPs framework could be improved. The study noted that training on how GRevPs are to be used and incorporated into daily work was deemed valuable. All the participants reported that ZAMRA has a consistent method for documenting those practices that need to be improved by GRevPs. A mechanism to facilitate updating GrevP at ZAMRA is currently in place, however, it requires enhancement. In general, the importance of GRevPs was well understood by the assessors, however the study showed that target timelines were not well followed at both the department and agency levels. This study has successfully determined the GRevPs used in the review process and their implementation by ZAMRA. It has provided a reference point from which the ZAMRA can work towards improvement as a means to enhance regulatory performance. The findings of this study will form the basis of development for the NRA as it strives to achieve the WHO Maturity Level 3 status.
Keywords: good review practices, Regulatory review, Optimising Efficiencies in Regulatory Agencies (OpERA), WHO Listed Authority, maturity level
Received: 15 Sep 2025; Accepted: 27 Oct 2025.
Copyright: © 2025 Chisha, Leigh, Siyanga, McAuslane and Walker. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Stephanie Leigh, stephanie.leigh@wits.ac.za
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