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The Authority opened for submission of human medicines applications in February 2020, and veterinary medicines in November 2020. Since then, the influx of human medicines has increased significantly. Submission of Veterinary medicines has been affected by the delay in the finalisation of the VMP listing exercise. This is witnessed with the number of applications submitted for screening (12) and subsequently for registration (2) to date.
At inception, BoMRA inherited a backlog from DRU, and below are the numbers of applications inherited. These applications were at different stages of the review process.
Table1: Applications received from the DRU and the backlog status as of the end of Q3 (31st December 2021)
Product Line | No. Inherited | Finalized / Closed | Current Backlog Status |
|---|---|---|---|
Human medicines applications | 400 | 335 | 65 |
Human Medicines Variations | 1000 | 843 | 157 |
Complementary medicines applications | 685 | 602 | 83 |
| Product line | No. Inherited | Product line | No. Inherited |
| Human medicines applications | 400 | 335 | 65 |
| Human medicines variations | 1000 | 843 | 157 |
| Complementary medicine application | 685 | 602 | 83 |
The Authority had set a target to reduce the backlog of the applications to 0% by 31st March 2022. This work has been faced with several challenges, that impacted the progress towards meeting the target or more precisely elimination of the DRU backlog. These challenges included but were not limited to:
The Medicines Regulatory Authority (“Authority”) is a corporate body, established under Section 3 of the Medicines and Related Substances Act (“MRSA”) and referred to as the Botswana Medicines Regulatory Authority or BoMRA. The Authority is responsible for ensuring the safety, efficacy, and quality of medicines and related substances, which includes both human and veterinary medicines, medical devices, and cosmetics in Botswana.
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