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S106: Assessment of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Opportunities and Challenges

Poster Presenter

Constance Chisha

PhD Student
University of the Witswatersrand
South Africa

Objectives

To assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones, target timelines achieved for products approved from 2020 to 2022, as well as good review practices and quality decision-making practices in the review process.

Method

A standardized, validated questionnaire; Optimising Efficiencies in Regulatory Agencies (OpERA), was completed by the author. It identified the key milestones achieved in the review process for products approved between 2020-2022, as well as good review and quality decision making practices.

Results

Currently, ZAMRA implement three review models to evaluate New Active Substances (NASs) as well as generic products. These include the verification model which was mainly used to review products prequalified by WHO or approved by a Stringent Regulatory Authority, the abridged process for products approved by an SRA and a full review for both NASs and generic products that were not prequalified by WHO. A fast-track application was used to expedite the review process for products of high public health concern which include mainly antimalarials, anti-cancers and anti-tuberculosis drugs. The Authority received mostly generic products as compared to the NASs Previously, key milestones were reported in the review process but due to manual reporting, these were difficult to assess for progress. However, with the introduction of the Integrated Regulatory Information Management System in 2021, applications are now tracked electronically. Despite these improvements, targets for each review milestone have not been established, although the Authority is in the process of developing the service charter that would indicate these specific timelines. A total of 327 products were approved during the period 2020-2022, which included 19 NASs and 318 generics. The overall approval time regardless of the type of model of review was 33, 49 and 47 months in 2020, 2021 and 2022, respectively for both generics and NASs. This reflects the queue time of 18 months as well as the fact that most applicants exceeded the set target timeline of 120 days by up to 6 months to respond to the questions thereby prolonging the overall review time. However, WHO PQ generics were reviewed within 90 days using the verification route. The Good review practices and quality decision making processes were followed in principle but have not been formally implemented. Guidelines related to the regulation of medicines were accessible by the public as they are published on the ZAMRA website.

Conclusion

This study evaluated the overall operation of the Zambian Authority and identified the key milestones achieved in the review process for products approved from 2020 -2022. The compliance of the Authority to the standard Good Review Practices and the Quality of the decision-making practices in the review process was monitored. It was demonstrated that there were no definite target timelines for each milestone and hence there is a need to establish and publish these timelines. These will be of value in assessing the performance of the review process within ZAMRA. The following recommendations resulted from this study: 1. Target Timelines: These need to be established for each milestone based on the review model and the type of the product. 2. Good Review Practices: These need to be standardized for the review process. 3. Transparency: This could be enhanced by publishing the summary of the evaluation reports and the decisions made for each product approved. 4. Reliance: To shorten the review times and ultimately the overall approval time there is need to implement a reliance model especially for NASs that have been approved by the SRA or ML-4 Agencies. 5. Benefit Risk Assessment: This is an important consideration to be included in the review process. The engagement of external assessors to expedite the review process and reduce on the backlog would be of value. 6. Well-structured quality decision making framework: would support consistency in the review process. 7. Stakeholder training workshops: on dossier compilation would support applicants and enable them to understand the requirements and improve the quality of the dossiers thereby reducing the approval timelines. The Zambian Authority is currently working towards attaining the World Health Organisation’s Maturity Level 3 as assessed by the global benchmarking tool, so the implementation of these recommendations would be key to securing this recognition and status.