A 20-year evidence-based experience of the evolving medicine regulation in Zanzibar.

Background: Access to medicine is crucial for the effective functioning of healthcare systems. A robust regulatory framework is necessary to ensure the safety, effectiveness, and availability. However, weak regulatory frameworks persist in many low- and middle-income countries, leasing to the circulation of falsified and substandard medicines as well as anti-competitive restrictions on registering poor-quality medicines, which poses a significant public health threat. This study evaluated the evolution of Zanzibar's medicine regulatory system over the past two decades and identified the key factors contributing to its success by elaborating on the Zanzibar Food and Drug Agency, seeking the expertise of regional, continental, and global experts to assess its regulatory capacity and maturity level.

Methods: This study was conducted at the Zanzibar Food and Drug Agency (ZFDA) in Unguja, Zanzibar, using a retrospective cross-sectional review and qualitative approach. It thoroughly reviewed relevant regulatory documents, including Acts, policies, guidelines, and assessment reports. Data were collected using a standardised checklist and analysed to uncover patterns and insights regarding the evolution of Zanzibar's medicine regulatory system.

Results: This study revealed substantial legal provisions, organisational development, strategic planning, and resource allocation improvements. Notable achievements include establishing a structured organisational framework, developing a comprehensive strategic plan, and implementing a Quality Management System (ISO 9001:2015 certified). The ZFDA also addressed human resource limitations by creating job descriptions and a staff scheme of service, enhancing financial resources through revised fee regulations and government support, and improving infrastructure with new office and laboratory facilities.

Conclusion: Zanzibar's medicine regulations have evolved significantly, with marked regulatory capacity and infrastructure improvements. Future efforts should address the remaining challenges and foster collaboration with regional and international bodies to ensure the continued evolution and effectiveness of Zanzibar's medicine regulatory framework.