The Medicines Regulatory Authority (MRA), in Uganda is called the National Drug Authority (NDA). It is responsible for the development and regulation of the pharmacies and drugs in the country, the importation, exportation and sale of pharmaceuticals, the quality of drugs supplied in the country; local production of essential drugs, research and development of herbal medicines, establishing and revising professional guidelines and dissemination of information to the health professionals and the public and providing advice and guidance to the Minister and bodies concerned with drugs on the implementation of the National Drug Policy.

In Uganda, legal provisions require marketing authorization (registration) for all pharmaceutical products on the market, however exceptions or waivers for registration do exist. Mutual recognitions mechanisms are in place that include WHO-EAC joint assessments. Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products.
In 2011, there were 7792 pharmaceutical products registered in Uganda. There are legal provisions requiring the MRA to make the list of registered pharmaceutical products publicly available and update it regularly. This register is updated monthly. Medicines are always registered by their INN (International Non-proprietary Names) or Brand name + INN. Legal provisions require a fee to be paid for Medicines Market Authorization (registration) based on applications.

Inspections are required by law and are a pre-requisite for the licensing of public and private facilities in Uganda. Inspectors are permitted by law to inspect premises where pharmaceutical activities are performed in both public and private facilities. Inspections are carried out on a number of entities including local manufacturers, private wholesalers, retail distributors and public pharmacies and stores. The local manufacturers are inspected at least twice a year. The manufacturers that are inspected for GMP compliance have to follow the WHO GMP guidelines. The National Medical Stores and the private pharmacies are licensed and inspected annually.

Legal provisions exist requiring authorization to import medicines. Laws exist that allow the sampling of imported products for testing. Legal provisions exist requiring importation of medicines through authorized ports of entry and inspection of imported pharmaceutical products at authorized ports of entry.

Manufacturers (both domestic and international), are required to be licensed and to comply with Good Manufacturing Practices (GMP). Good Manufacturing Practices are published by the government. Importers, wholesalers and distributers are required to do the same and comply with the Good Distributing Practices. Pharmacists are required to be registered and pharmacies licensed, both private and public. However, by law, a list of all licensed pharmaceutical facilities is not required to be published.

In Uganda, a laboratory, which is a functional part of the MRA, exists for Quality Control testing. However, the NDA also contracts services elsewhere. This is done for microbiological, public health and herbal product testing. Medicines are tested for quality monitoring in the public and private sectors and for public program products prior to acceptance and/or distribution.

In Uganda, legal provisions exist requiring authorization for conducting Clinical Trials by the MRA. There are additional laws requiring the agreement by an ethics committee or institutional review board of the Clinical Trials to be performed. Clinical trials are required by law to be entered into an international/national/regional registry. Legal provisions exist for GMP compliance of investigational products and permit the inspection of facilities where clinical trials are performed. Sponsor investigators are legally required to comply with Good Clinical Practices (GCP) and the National GCP regulations are published by the Government.

There are legal provisions in the Medicines Act that provide for pharmacovigilance activities as part of the MRA mandate in the country. However, legal provisions requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA do not exist. Laws regarding the monitoring of Adverse Drug Reactions (ADR) also do not exist. Uganda has a national pharmacovigilance center which is linked to the MRA. There is also a national ADR or pharmacovigilance advisory committee able to provide technical assistance or causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication in Uganda. A clear communication strategy for routine communication and crises communication exists.

Uganda’s MRA, the NDA, disseminates pharmaceutical related information to the citizens and other interested parties through the NDA website. The manufacturers can access registration guidelines on the website while the practitioners can also acquire their licenses from this portal. It contains useful information from the state of the law on various pharmaceutical sectors like clinical trials, GMP, GDP, pharmacovigilance to quality control, inspection, and licensing guidelines. Uganda is also a member of the EAC and obtains some benefits from the medicine regulation harmonization policies that has been established across Eastern Africa.