The transition of regulatory services from drug regulatory unit to Botswana medicines regulatory authority: an evaluation of the changes in regulatory services from the industry’s perspective
Abstract
The Drug Regulatory Unit (DRU) was established by the Ministry of Health (MoH) to enforce the Drugs and Related Substances Act of 1992 in line with the Botswana National Drug Policy (BNDP) adopted in 2002 and the National Health Policy (NHP) to attain health for all. However, as with many National Regulation Authorities (NRAs) in low and middle-income countries, the DRU had major challenges in inefficient legislation and regulation to address the supply of substandard and falsified medicines, and financial and human resource constraints to maintain and sustain regulatory oversight. The Government of Botswana through the MoH restructured DRU into a semi-autonomous regulatory body, Botswana Medicines Regulatory Authority (BOMRA). To aid the NRAs in building and strengthening regulatory systems' capacity to regulate medicinal products effectively and efficiently, the World Health Organization (WHO) has generated a Global Benchmarking Tool (GBT) for member states. As of December 2019, a total of 26 countries underwent formal benchmarking while 54 countries including Botswana completed self-assessments using the WHO-GBT. Despite this self-assessment, there might be a need to assess the efficiency of the regulatory service delivery of BOMRA from the industry’s perspective. The study aimed to assess and compare the changes in the regulatory system for the WHO-recommended regulatory functions and service delivery following the transition of DRU to BOMRA from the industry’s perspective.
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