The Directorate of Pharmacy, Laboratories and Traditional Medicines (DPHL/MT), which is a part of the Ministry of Public Health in Niger, regulates medicines in Niger. The DPHL/MT is responsible for participating in the design, implementation, monitoring and evaluation of the national health policy in pharmacies, laboratories and traditional medicine. The functions of the DPHL/MT include:
•      Coordinating the implementation of the national policy in the field of drugs, laboratories and traditional medicine.
•      Overseeing the planning, implementation, monitoring and evaluation of activities in the fields of pharmacy, medicine, traditional medicine and medical biology
•      Participate in the development and application of legislative and regulatory texts relating to pharmacy, drugs, chemicals, narcotic drugs and psychotropic drugs, laboratory activities and traditional medicine activities
•      Participating in studies and research in the fields of medicine, traditional medicine and medical biology
•      Coordinating the supervision of import and wholesale distribution establishments of manufacturing and preparation establishments, pharmacies, drug depots, laboratories and traditional medicine establishments
•      Overseeing the processing of applications for the opening of private establishments in the fields of pharmacy, laboratory and traditional medicine
•      Coordinating the training and information actions for prescribers, dispensers and consumers on drug issues (Ministère de la Santé Publique, 2014)

There are legal provisions that insist that all drugs on the market need a marketing authorization. There are explicit, accessible criteria to the public, for the assessment of marketing authorization applications for pharmaceuticals. Marketing authorization and renewals are issued by the Ministry of Public Health after a deliberation of the Drug Selection Committee.

Importing medicines requires authorization by the NMRA. The National Office for Pharmaceutical and Chemical Products (ONPCC) was created by Law No. 62-36 of September 18, 1962 with exclusive import monopoly. The monopoly of the ONPCC was lifted and followed by the liberation of the pharmaceutical sector in 1996. The ONPCC’s website can be accessed via: http://www.onppc-niger.com/. The control of medicine importation in the public sector is structured but importation is not as controlled in the private sector. There are two ports of entry: by air and by road. There are regulations to inspect medicines at ports of entry, however, there are no pharmaceutical inspectors at these points of entry.

Inspections of facilities are not carried out usually by the DHPL/MT. The General Inspector of Services is responsible for inspections in Niger. However, in the absence of the General Inspector, the NMRA inspects wholesalers, local manufacturers and distributors.

Manufacturers, importers, wholesalers, retailers, and public and private pharmacies required to be licensed before operating.

The National Laboratory of Public Health and Expertise (LANSPEX) was created to ensure the quality of locally manufactured and imported products. WHO accepted LANSPEX as a reference laboratory for the WHO prequalification process. Other African countries such as, Burundi, Chad, Central Africa Republic, Rwanda and Togo, also request for services from LANSPEX.

Market authorization holders are required to monitor the drugs they put on the market and report adverse reactions and events to the NMRA. There is no National Center for Pharmacovigilance in the country and no national database for adverse events, so reports are not sent to the WHO database in Uppsala. However, there are standardized ADR reporting forms that are used to report adverse events.

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

According to the responses of Niger in the WHO Pharmaceutical Sector Country Profile, the DPHL/MT has a computerized information management system but only marketing authorization information is computerized.