The Drug Information Department (DID) is one of the technical departments of the National Drug Authority which actively participates in the implementation of the objectives of the National Drug Policy and Authority Act. 

Structure of Drug Information Department

• Human medicines
• Veterinary Medicines

• Human Medicine
• Veterinary (Ectoparasiticide field trials)

DID Main Activities
The main activities of Drug Information Department are to:

Clinical trials

Section 40 of the NDP/A Act mandates NDA to regulate issues related to safety, quality, efficacy, handling and use of pharmaceutical and other medical products used in research clinical trials. In a broad sense, the role of the NDA in drug development and research, including clinical trials, is derived from its mission to ensure quality, safety and efficacy of human and veterinary medicines and other health care products through regulation and control of their production, importation, distribution and use.
The goals include the protection and promotion of public health by ensuring the safety, efficacy and quality of medicines, and their appropriate use; and ensuring the appropriateness of medicines information provided to the public and health professionals.
NDA has written out a set of guidelines in conformity with the national and international requirements for clinical trials. It is required that any clinical trial using registered or unregistered medicine must receive written approval from NDA for that purpose. These guidelines include procedures that should be followed by applicants who wish to conduct clinical trials in Uganda and the steps that NDA will take to review, evaluate and permit the conduct of such trials. It is important to note here that approval by NDA does not absolve the applicant from compliance with all laws and regulations in Uganda. In particular, other laws may apply to import or use of infectious or genetically modified organisms.

For more information on the guidelines and clinical trial application procedures, please click the following link:  
Guidelines for the conduct of clinical trials

Draft on the conduct of Ectoparasiticide field trials

Clinical Trial Monitoring
 The National Drug Authority (NDA) today has a series of new regulatory developments intended to protect the rights and welfare of patients and to verify the quality and integrity of data submitted for review in clinical trials NDA has established a clinical research monitoring program that includes inspection of investigators at their clinical trial sites for good clinical and laboratory practices.  An inspection or audit of clinical trial site may be conducted by the NDA at any time before, during and after the trial. 

The Inspections will include - but not be limited to: the facilities and staff used for the trial, compliance with the approved Protocol, all amendments to the protocol which may have been approved, accurate, complete and current records according to the protocol, verifying that serious adverse events are reported as required by the protocol.

Pharmacovigilance
Pharmacovigilance is defined as the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines.

The National Drug Authority hosts the National Pharmacovigilance Centre (NPC).The center was established in 2005. The goal of the centre is to promote patient safety by monitoring adverse drug reactions.

In 2007, the NPC of Uganda, which had been an associate member of the WHO Adverse Drug Reaction (ADR) monitoring centre based in Uppsala, Sweden, became a full member.

The National Drug Authority hosts the National Pharmacovigilance Centre (NPC).The center was established in 2005. The goal of the centre is to promote patient safety by monitoring adverse drug reactions.

In 2007, the NPC of Uganda, which had been an associate member of the WHO Adverse Drug Reaction (ADR) monitoring centre based in Uppsala, Sweden, became a full member.

The roles of the NPC are to:

• Train and sensitize health workers on monitoring and reporting adverse drug events.

• Developing and disseminating Pharmacovigilance related guidelines for more information on guidelines click on the link Draft Pharmacovigilance guidelines

• Develop and disseminate adverse drug reaction (ADR) reporting forms and collect ADR reports. Link Human Adverse Drug Reaction Form

• Maintain an adverse drug reactions database

• Review  and  analyze Adverse Drug Reactions received at the centre and  take appropriate action

Drug promotion

The National Drug Authority is the guardian of public interest concerning drugs.
Any Drug Information reaching the public in Uganda must first be vetted by, and obtain approval from the National Drug Authority.
Ethical Drug Promotion practices include a number of activities and therefore must follow certain criteria to ensure that the public has access to useful, properly detailed unbiased information.

The Drug Information, Clinical trials and Pharmacovigilance Department has achieved quite a number of targets in the past year under review including:

Dissemination of Drug Information and regulation and control of drug promotion

Revised/reviewed the guidelines on drug promotion, developed regulations from the guidelines. More...