Related Experiment Video
Updated: Nov 23, 2025
Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model
Published on: October 31, 2010
Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities
Tariro Sithole1,2, Gugu Mahlangu2, Sam Salek1,3
1School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK.
Purpose:
The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate the overall performance from 2017 to 2019, identify good review practices, evaluate the quality of decision-making processes, and identify the challenges and opportunities for improvement.
Methods:
A questionnaire was completed by the MCAZ. The agency has participated in the Optimising Efficiencies in Regulatory Agencies (OpERA) program, a multinational endeavor to characterize assessment procedures and metrics associated with regulatory agencies and regional regulatory initiatives. Data identifying the milestones and overall approval times for all products registered MCAZ from 2017 to 2019 were collected and analyzed.
Results:
The MCAZ conducts a full review of quality, safety, and efficacy data for generics and biosimilars not approved by a reference agency, an abridged review for products approved by a reference agency and a verification review for World Health Organization prequalified products under the collaborative registration procedure. The highest number of reviewed products is generics manufactured by foreign companies. There has been an improvement in review times for all categories of products over the three-year period. Guidelines, standard operating procedures, and review templates are in place and the majority of indicators for good review practices are implemented. Although quality decision-making practices are implemented, there is no formal framework in place.
Conclusion:
The MCAZ successfully implements three types of review models in line with international standards. Overall, target timelines are realistic and what is achievable with the current available resources. Recommendations made such as the review of available human resources, separation of agency and company time when setting and measuring targets, review of the templates and benefit-risk framework used for abridged review, and development of a decision-making framework present opportunities for an enhanced regulatory review process.
Related Concept Videos
01:03Drug Control Governance: Regulatory Bodies and Their Impact
01:25Drug Regulation
01:28Global Regulatory Systems
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
02:24Regulation of Expression Occurs at Multiple Steps
02:24Regulation of Expression Occurs at Multiple Steps
Transcription results in the generation of precursor (pre-mRNA) that consists of both exons and introns, which needs further processing before being translated to a...