Mandate of the Directorate

Directorate of Product Safety ensures that the medicines marketed and used in Uganda meet acceptable levels of safety, quality and efficacy. The directorate team is responsible for pharmacovigilance, safety, regulation of clinical and field trials, exchange of medicines information on and regulation of the promotion of medicines and healthcare products.

The directorate is partitioned into distinct units, each being headed by either a manager or principal officer, who directly supervise their respective regulatory officers; and all the units are under the stewardship of the director. These units are arranged according to the various regulatory function and additionally, there is a separate unit for veterinary drug regulation.

Resources

Director Product Safety
Dr. Hellen Ndagije Byomire

NDA-notfound

Manager Clinical Trials
Dr. Nakitto Diana Kesi

NDA-notfound

Manager Pharmacovigilance
Dr. Mayengo Julius

Uppsala Reports, the pharmacovigilance magazine from Uppsala Monitoring Centre

Key Activities

Medical products vigilance, defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medical product-related problems, is extremely important for guaranteeing that safe and effective medical products of high quality are used within the country. The pharmacovigilance unit conducts all activities relating to safety data collection, assessment and communication of safety information on medicines to the concerned stakeholders. Stakeholder engagement and sensitization on pharmacovigilance activities is key to the work done. Vigilance activities are based on a risk management approach.

  • There are 14 regional pharmacovigilance centres based in national and regional referral hospitals. The coordination of activities countrywide is hinged onto the regional pharmacovigilance centres which are of two types: the regional and national referral hospitals and the NDA regional offices. The NDA regional managers are important in following up the issues of poor quality and lack of efficacy in the private sector as well as receive the adverse drug event reports from public health facilities. The hospital-based centres manage the adverse drug events and medication errors, conduct some preliminary assessment and submit the ADR reports through Vigiflow or manually filled report through the pharmacovigilance centre.
  • The National Pharmacovigilance Centre in NDA runs a reporting system to monitor the safety of medical products. One important activity within that function is to monitor and assess side effects and other product-related safety issues (e.g., adverse drug reactions (ADRs) for medicines, and adverse events following immunization (AEFI) for vaccines).
  • The Ugandan National Pharmacovigilance Centre is headed by the Director of Product Safety and is a member of the WHO Programme of International Drug Monitoring. Uganda also participates in the East African Community pharmacovigilance expert working group where it seeks to harmaonise vigilance systems and safety requirements in the region. Networking with other international bodies and regulators is important for acquiring, sharing, and exchanging the relevant information on medical products safety. This feeds into evidence-based decisions about drug safety in a timely manner.

In line with section 40 of the National Drug Authority and Policy Act Chapter 206 of the Uganda laws authorizes and regulates drug related clinical and field trials in Uganda to ensure the safety and wellbeing of study participants and also ensure that the data generated from the trials is scientifically valid and reliable. The unit does this through review and approval of clinical trial applications, conduct of clinical trial site inspections for compliance to good clinical practices, development of guidance documents, stakeholder engagement. Clinical Trial Certificates are issued and renewal is granted on an annual basis for the duration of the trial. Variations in clinical trial applications are assessed for approval. Clinical trial protocol deviations, protocol violations, trial termination or suspensions, updates of Investigator Brochures following new safety information are some of the activities handled by the unit. Safety information arising out of the ongoing clinical trials is also assessed by the unit.

Control of publication of descriptive matter in relation to drugs is the mandate of NDA under section 33 of the NDPA Act. The medicines information unit champions rational advertisement of medicines by vetting promotional materials to ensure that the information is not misleading and targeted to the right audience. The unit regulates drug labelling and drug promotions in the market for illegal advertisements. Other activities include provision of information to prevent drug and substance abuse, and promote appropriate and safe use of medicines.

The research unit was established to promote knowledge management across NDA by building systems that support research and innovation. This has necessitated building capacity to retain institutional knowledge. This unit coordinate operational research activities within the organization including collaborative and supported research activities with staff

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