The Department of Pharmaceutical Services, Laboratories and Traditional Medicine is the regulatory authority for the Central African Republic (WHO & The Global Fund, 2011). There is no indication of the use of an Integrated Regulatory Information Management System.

Pharmaceutical products are authorized by the Department of Pharmaceutical Services, Laboratories and Traditional Medicines. These products go through a review process upon an authorization request. The products are evaluated based on a criterion that is made available to the public. Market authorization certification is essential for all marketed products. Information on the technologies used throughout the process is not known.

Inspections are conducted in the Central African Republic. Inspectors are usually appointed to inspect the premises of various pharmaceutical establishments. Inspections are required to take place in every area where pharmaceutical activities take place. Products manufactured must be GMP compliant. Inspections are mandatory before licenses are granted. Inspections are done occasionally. Information on the software used in this process is not available.

Per a survey conducted by the World Bank and the Global Fund, the Central African Republic does not have a national pharmacovigilance centre. However, in the absence of a national pharmacovigilance centre, the effects of drugs are monitored. The processes and technologies used in monitoring the effects of drugs are currently not available.

The pharmaceutical regulatory authority does not authorise clinical trials. However, to carry out a clinical trial, it requires approval from the committee of ethics or the institutional examination board. Details of clinical trials must be entered into a registry. Software used in this module is not known.

Post Market surveillance is not conducted in the Central African Republic. Inspectors do not collect samples on the market for post-market control evaluation based on post-market controls.

The regulatory authority controls the importation of pharmaceutical products into the country. Medicines are only imported if they have been authorized. Samples of products are subject to review. Medicines can only be imported through the authorized ports of entry (World Trade Organization, 2010). Imported products are also inspected at the authorized port of entry. Information on the software used in this process is not used.

Pharmacists are required to be licensed to operate in the Central African Republic. The pharmacist professional behaviour is overseen by the association of professional code of conduct (WHO & The Global Fund, 2011). Manufacturers, distribution centres and all pharmaceutical establishments are required to hold a license before operating. The licensing process and the technologies used are currently not available.