Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities

Abstract

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.

Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

“…This could be due to the significantly lower resources; for example, the number of assessors, available to ZaZiBoNa countries when compared with countries in the other initiatives. Most of the active member countries in ZaZiBoNa are faced with the challenge of limited resources and a high number of applications ( 4 , 10 , 15 – 17 ) for the national procedure, which negatively impacts the work-sharing initiative. The use of a regional unit to coordinate assessments would also assist in addressing the identified challenges, particularly in a resource-constrained setting.…”

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

“…Accordingly, various measures are being implemented to achieve this including the objective of responsive public institutions [18]. The Medicines Control Authority of Zimbabwe (MCAZ) is an autonomous agency under the Ministry of Health and Child Care and successor to the Drugs Control Council established by an Act of Parliament, the Drugs and Allied Substances Act of 1969 [19,20]. The MCAZ is responsible for regulating medicinal products for human and veterinary use as well as medical devices [20] and there are plans to expand its scope of control to wider medical devices and blood and blood products.…”

“…The Medicines Control Authority of Zimbabwe (MCAZ) is an autonomous agency under the Ministry of Health and Child Care and successor to the Drugs Control Council established by an Act of Parliament, the Drugs and Allied Substances Act of 1969 [19,20]. The MCAZ is responsible for regulating medicinal products for human and veterinary use as well as medical devices [20] and there are plans to expand its scope of control to wider medical devices and blood and blood products. The scope of activities carried out by the MCAZ are the issuing of marketing authorizations/product licenses, post-marketing surveillance, laboratory analysis of samples, clinical trial authorization, regulation of advertising, site inspections/visits, import and export control, and licensing of premises and persons responsible for the manufacture, supply, distribution, storage, and sale of medicines [20] Over the years, the MCAZ has been involved in various activities with the aim to improve capacity, for example, participation in the WHO prequalification of medicines and global benchmarking programmes as well as the Southern African Developing Community (SADC) regional work-sharing initiative, ZAZIBONA.…”

Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

“…As a result, one of the challenges that has been identified with this initiative is the fact that differences in country review processes result in questions to applicants for the same product being sent at different times by the countries, affecting registration timelines and negating the benefit of simultaneous access to various markets. Sithole et al therefore recommended that the regulatory review processes in the individual participating countries be reviewed and the outcomes compared (3,5). The aim of this study therefore was to review and compare the registration processes of regulatory authorities of Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe to develop recommendations for better alignment, while presenting an opportunity for the countries to learn from each other and enhance their regulatory review and patients' access to life-saving medicines.…”