Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices

ABSTRACT

Background

Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients’ access to medicines. The aim of this study was to compare the medicines registration process of the Medicines Control Authority of Zimbabwe (MCAZ) with the regulatory processes in Australia, Canada, Singapore, and Switzerland.

Methods

A questionnaire that standardizes the review process, allowing key milestones, activities and practices of the five regulatory authorities was completed by a senior member of the divisions responsible for issuing marketing authorizations.

Results

The MCAZ has far fewer resources than the regulatory authorities in the comparator countries, but employs three review models, which is in line with international best practice. The MCAZ registration process is similar to the comparator countries in key milestones monitored, but differs in the target timelines for these milestones. The MCAZ is comparable to the comparator authorities in implementing the majority of good review practices, although it significantly lags behind in transparency and communication.

Conclusion

This study identified the MCAZ strengths and opportunities for improvement, which if implemented, will enable the achievement of its vision to be a leading regulatory authority in Africa.

KEYWORDS:

• Medicines Control Authority of Zimbabwe (MCAZ)
• international best-practice
• improved medicines access
• registration of medicines
• low- and middle-income countries (LMIC)

Acknowledgments

The authors wish to thank the Therapeutic Goods Administration, Health Canada, Health Sciences Authority, Swissmedic and the Medicines Control Authority of Zimbabwe. The authors also wish to thank Mrs Patricia Connelly for the editorial assistance.

Author contributions

TS acquired, analyzed and interpreted the data and drafted the manuscript; SS designed the study, analyzed and interpreted the data and critically reviewed the manuscript; GM analyzed and interpreted the data and critically reviewed the manuscript; SW designed the study, analyzed and interpreted the data and drafted the manuscript.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Ethics

The study was approved by the Health, Science, Engineering and Technology ECDA, University of Hertfordshire [Reference Protocol number: LMS/PGR/UH/04350].

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This research was supported by the Jenny Greenhorn Memorial scholarship, administered by the University of Hertfordshire as well as an unrestricted grant from the Bill and Melinda Gates Foundation.