The Directorate General of Pharmacy, Medicines and Laboratories (DGPML) is the regulatory body, responsible for regulating the pharmaceutical sector in Burkina Faso. The DGPML has the following units: Pharmaceutical Regulation and Licensing Department, Directorate of Laboratories, Department of Securing Pharmaceutical Supplies and the Directorate of Traditional Medicine and Pharmacopoeia. The functions of the DGPML are product registration, licensing, inspection, import control, clinical trials, pharmacovigilance, market and quality control, and drug advertising and promotion.

There are regulations that insist that all products marketed on the Burkinabe market must be registered regardless of exemptions and exceptions that exist at this level. The criteria for evaluating market authorization requests is not made available to the public.

There are legal provisions that require that manufacturers, wholesalers and retailers to gain licenses before they begin operation. The Good Manufacturing Practices, distribution and storage standards are not yet formally considered in the regulations, so there are no legal provisions imposing on wholesalers and distributors to comply with Good Distribution Practices.

Inspection is required by law and a pre-requisite for the approval of private pharmaceutical facilities. Inspection is carried out on private wholesalers, retail distributors, pharmacies and public warehouses, and pharmacies and dispensing points of health establishments.

·       The National Laboratory of Public Health (LNSP) which takes samples from customs ports to carry out quality control assessments.
·       The DGPML which provides a visa on all product import invoices and certifies pharmaceutical companies’ marketing authorization.

Drug samples are collected by inspectors for post-market surveillance. Drug samples are sent to the laboratory in charge for analysis. Samples are tested on the following basis: For quality control in the public and private sector, when there are complaints or problem reports and for preselection for purchase from the public.

To conduct clinical trials in Burkina Faso, it is required by law to have authorization from the DGPML. The principal investigator and sponsor also need t the approval of an ethics committee or a board institutional review of clinical trials to be performed.

There is a national pharmacovigilance centre that collaborates with the DGPML. There also exists a national database for adverse event reports. These reports are sent to the WHO collaborating monitoring centre in Uppsala. There are laws that insist that the MA holder continuously monitors all the drugs he put on the market and report on the safety of those products.

The NMRA has a computerized information management system to store and retrieve information on the various procedures, registrations, inspections, and other regulatory functions (World Health Organization, 2011).

In Burundi, the regulation of the pharmaceutical sector is ensured by the Ministry of Public Health, through the Department of Pharmacy, Drug, and Laboratory, as well as the General Inspection of Public Health and of the fight against AIDS. The country has put in place plans to set up a National Drug and Food Regulatory Authority (NDFRA) to oversee the medicine regulations in the country.
Once adopted, the NDFRA will be responsible for regulating all aspects related to quality assurance and the safety of products such as prefabricated and packaged foods, medicinal products, human and veterinary use, phytosanitary products, cosmetics, herbal medicines, traditional remedies, medical devices or materials or substances used in the manufacture of products whose consumption may be harmful to human and animal health.

Burundi currently uses its MoH website to share information with its citizens. It heavily relies on the East African Community (EAC) Medicine Regulation Harmonization system for regulation of the pharmaceuticals supply in the country.