An Evaluation of the Regulatory Review System in the Southern African Development Community Work Sharing Initiative (ZaZiBoNa): Enhancing the Review Process and Patients’ Access to Medicines

Abstract

Countries on the African continent have varying capacities to regulate medical products, although all 54 countries, except one, have a regulatory authority or department within the ministry of health responsible for the regulation of medicines. These challenges in capacity have led to protracted timelines delaying access to quality assured medicines as well as the problem of substandard and falsified medicines. To mitigate these challenges, regulatory harmonisation and collaboration through the pooling of expertise and resources of the regulatory authorities in the regional economic communities (RECs) has been implemented through the African Medicines Registration Harmonisation Initiative (AMRH), established in 2009. One such collaboration is the Southern African Development Community work sharing initiative, ZaZiBoNa.

The aim of this research programme was to evaluate the regulatory review system in the ZaZiBoNa initiative with a view to enhancing the review process and ensuring patients’ access to medicines. This was achieved through a review of the history of the ZaZiBoNa initiative focusing on what had been realised in its eight years of operation and what still needed to be achieved. The registration process of the agency responsible for coordinating ZaZiBoNa, MCAZ, was evaluated and compared with mature regulatory authorities of comparable size in order to benchmark best practices. The regulatory review processes of the individual participating countries that contribute to the ZaZiBoNa reviews and GMP inspections were evaluated and strategies for alignment proposed. Lastly, the applicants’ and regulatory authorities’ views on the effectiveness and efficiency of the ZaZiBoNa initiative were evaluated. A mixed methods research design, incorporating both quantitative and qualitative methods was selected. A purposive sampling technique was used for data collection using techniques such as narrative literature review, self-administered questionnaires and semi-structured interviews.

The results of the evaluation of the MCAZ indicated that the agency successfully implemented the three review models and was largely able to achieve comparable timelines to mature regulatory agencies by using reliance. However, the results also showed that in its current capacity the MCAZ was not able to achieve its target timelines due to issues related to Covid-19 pandemic. The results of the evaluation and comparison of the regulatory review processes of the individual participating countries showed that although the processes were similar, there was great variation among the countries in the target timelines set for key milestones and the frequency of expert committee meetings which contributed to the differences in the implementation of ZaZiBoNa recommendations by member countries. The results of the evaluation of the ZaZiBoNa initiative by regulatory authorities and pharmaceutical companies documented the successes and challenges of this initiative as well as measures that might improve its effectiveness and efficiency. The benefits and challenges to regulators, applicants and patients were also identified. Overall, the results of these studies culminated in the development of a proposed improved model for the ZaZiBoNa initiative.

This research programme has provided insight into the regulatory review processes of low-and-middle income countries in the SADC region and how these impact the ZaZiBoNa initiative. The evaluation of the initiative by regulatory agencies and pharmaceutical industry provides valuable stakeholder feedback which if implemented will enhance the review process and patients’ access to medicines. This programme of research has presented, in a vital piece of work, key recommendations for the improvement of the regulatory review system in ZaZiBoNa including a proposed improved new model.