Odokonyero Kennedy
On 4 September 2025, Uganda’s Ministry of Health introduced in Parliament the National Drug and Health Products Authority Bill, 2025, for its first reading. The bill seeks to repeal the National Drug Policy and Authority (NDPA) Act of 1993, which established Uganda’s current regulatory body, the National Drug Authority (NDA).
The Speaker of Parliament referred the bill to the Health Committee, which has begun receiving submissions from stakeholders. The public has until 10 October 2025 to provide comments.
A notable feature of the bill is the expanded mandate of the regulatory authority. Beyond human drugs, the authority will now regulate medical devices, cosmetics, nutritional supplements, and public health products. Veterinary drugs, however, will fall under a separate entity.
Regular readers of this newsletter will recall that I have previously highlighted how the NDA has been anticipating this law to strengthen and broaden its regulatory functions. Since the bill was introduced, I have been analyzing it from a pharmacovigilance (PV) perspective—to identify its strengths, propose improvements for Parliament’s consideration, and explain why Marketing Authorisation Holders (MAHs) should pay close attention.
Strengths
- The definition of adverse event covers all regulated products under the bill’s scope.
- The authority is clearly mandated to monitor the safety and quality of drugs, medical devices, cosmetic products, public health products, and nutritional supplements.
- Pharmacovigilance systems are required for manufacturers, distributors, and importers of drugs.
- There is legal backing for regulatory reliance and adoption of international technical guidelines.
- The authority may request stakeholders to participate in safety and efficacy studies.
- Pharmacovigilance inspections are explicitly provided for.
- Issuance of a Good Manufacturing Practice (GMP) certificate is tied to the establishment of a PV system.
- Healthcare professionals are obliged to monitor the safety of supplied drugs and report adverse events to the authority.
- The authority must share safety data with regional and international monitoring systems.
- Healthcare professionals and businesses dealing in medical devices are required to report adverse events.
- Stakeholders—including manufacturers—are obligated to establish safety monitoring systems for all regulated products.
- There are penalties for non-compliance with PV requirements, including fines (up to 5,000 currency points), imprisonment (up to five years), cancellation of licenses, or a combination of these.
Recommendations
- The definition of adverse reaction should be broadened to include all regulated products, not just drugs and nutritional supplements.
- While the bill requires authorisation for imported donated drugs, it does not specify who is responsible for monitoring their safety. This obligation should clearly rest with the importing entity.
- Retail pharmacies should be explicitly required to collect and report adverse events.
- Beyond linking GMP certification to PV systems, the authority should also make registration, renewal of marketing authorisation, and product retention conditional on the establishment of robust PV systems by applicants or MAHs.
Why Should MAHs Care?
The bill, as drafted, makes it impossible for MAHs to obtain a GMP certificate without first establishing PV systems. Without GMP, products cannot be registered—and without registration, they cannot reach the market.
If Parliament adopts the recommended amendments, renewal of marketing authorisation and continued market access will also depend on functional PV systems. In short: no PV system, no market access.
To MAHs: Do not wait for this bill to become law. Begin setting up your local PV systems now to safeguard your products’ future in Uganda’s market.
Conclusion
The National Drug and Health Products Authority Bill, 2025, represents a major step forward in strengthening Uganda’s regulatory framework for medicines and health products. By expanding the authority’s scope and embedding pharmacovigilance obligations across the supply chain, the bill lays the foundation for a safer, more accountable health system.
However, some gaps remain—particularly around the definition of adverse reactions, safety monitoring of donated drugs, and the role of retail pharmacies in pharmacovigilance. Addressing these issues will ensure that the law is not only comprehensive but also practical in safeguarding public health.
For Marketing Authorisation Holders, the message is clear: compliance with pharmacovigilance is no longer optional. It is central to market access and product retention. Preparing early will not only ease compliance but also position companies as proactive partners in advancing patient safety in Uganda.
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