Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities

Constance Sakala Chisha; Makomani Siyanga; Stephanie Leigh; Adem Kermad; Stuart Walker

doi:10.1007/s43441-024-00730-6

Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities

Ther Innov Regul Sci. 2024 Dec 27. doi: 10.1007/s43441-024-00730-6. Online ahead of print.

Authors

Constance Sakala Chisha^{1

2}, Makomani Siyanga², Stephanie Leigh³, Adem Kermad⁴, Stuart Walker^{1

4}

Affiliations

¹ University of Witwatersrand, 7 York road, Parktown, Johannesburg, 2017, South Africa.
² Zambia Medicines Regulatory Authority, P. O Box 31890, Lusaka, Zambia.
³ University of Witwatersrand, 7 York road, Parktown, Johannesburg, 2017, South Africa. [email protected].
⁴ Centre for Innovation in Regulatory Science, 70 St Mary Axe, London, EC3A 8BE, UK.

PMID: 39729229
DOI: 10.1007/s43441-024-00730-6

Abstract

Purpose: This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products approved from 2020 to 2023, as well as good review and quality decision-making practices implemented in the review process.

Methods: A standardised, validated questionnaire; Optimising Efficiencies in Regulatory Agencies (OpERA) and the OpERA Data Collection Template were completed by the author.

Results: Three review models are used by ZAMRA to review new active substances (NASs) and generic products: verification, for products prequalified by the World Health Organization or approved by a stringent regulatory authority (SRA); abridged, for well-established molecules or SRA-approved products; or full, for products not otherwise prequalified. Good review practices and quality decision-making processes were followed but could be improved.

Conclusion: This study assessed the overall ZAMRA operation and identified the key milestones in the review process for products approved from 2020 to 2023, target timelines achieved and the compliance to standard good review and quality decision-making practices.

Keywords: Good review practices; Key milestones; Quality decision-making process; Regulatory review models; Zambia Medicines Regulatory Authority (ZAMRA).