The Directorate of Pharmacy and Medicine of the Republic of Congo (la Direction de la Pharmacie et du Médicament de la République du Congo) is responsible for pharmaceutical dispensing and drug manufacturing in Congo (DPM CONGO, 2020). There is currently no indication of the use of an integrated Regulatory Information Management System (I-RIMS).

With regards to the DPM-Congo, the approval process is known for the registering of medicines and placing them on the market in Congo (DPM CONGO, 2020). The forms of approvals include market authorization, marketing authorization renewal and market authorization extension (DPM CONGO, 2020). These drugs are evaluated based on standards regarding quality, efficacy, safety and cost. The information regarding the processes involved and the technology used in registration is currently not available.

According to the book, Congo goes by World Health Organization requirements set for GMP compliance during inspections, until they develop their national requirements (WHOPAR, 2014). In the pharmaceutical policy of 2004, they hope to partake in the directorate and regional inspections to halt the fight against drug trafficking and the illicit use of narcotic drugs (Ministère de la Santé et de la Population, 2004). “The General Health and Inspection of Pharmacies and Laboratories” is responsible for ensuring good manufacturing practices for pharmaceutical products and good laboratory practices and guaranteeing the quality of drugs on the market (Makinen et al., 2012).

The Republic of Congo would open its national pharmacovigilance centre soon (DPM CONGO, 2019b). However, pharmacovigilance measures are being undertaken, and training is ongoing to educate various health profession (CANTAM, 2020). Moreover, the exact adverse drug reporting processes used are not provided. There is no information on the technologies used in this aspect.

There are various structures in place for research such as clinical trials, but there’s an absence of policy to promote research in the health and pharmaceutical sector (Ministère de la Santé et de la Population, 2004). Various bottlenecks hinder research from being done. The National Pharmaceutical policy aims to encourage biopharmaceutical research by developing mechanisms to exploit research results and to develop a partnership framework between national research institutions (Ministère de la Santé et de la Population, 2004).

There is no indication currently of post-market controls available in the Republic of Congo. Per the National Pharmaceutical policy of 2004, they hope to set up a pharmaceutical body responsible for post-market surveillance (Ministère de la Santé et de la Population, 2004).

According to the National Pharmaceutical Policy, 2004, the government had not put in place monitoring and evaluation mechanisms in pharmacy and medical biology (Ministère de la Santé et de la Population, 2004). However, strategic objectives were established to enhance monitoring and evaluation. These include the use of monitoring and result evaluation indicators to access the activities of the industry. It is outlined that internal evaluations would be carried out each year (Ministère de la Santé et de la Population, 2004).

The Republic of Congo mainly imports medicines and pharmaceutical products. As of 2004, the national pharmaceutical policy indicated that there was a need to draw up a decree establishing an authorisation system for the importation of medicines and medical products (Ministère de la Santé et de la Population, 2004). The annual cost on the importations of medicines and pharmaceutical products is approximately 20 billion CFA (Ministère de la Santé et de la Population, 2004). There is no information available currently on the processes used when importing and exporting in the Republic of Congo.

In the Directorate of Pharmacy and Medicine, the price structure for regulatory services is fixed based on the law established (DPM-Congo, 2020). There is no information on the use of any software concerning the payment of services or other aspects of finance.
Licensure – Professionals and Premises
The Directorate of Pharmacies, Laboratories and Medicines is responsible for licensing pharmaceutical establishments. Pharmacists must be registered with the national order for pharmacists to practice in the Republic of Congo (DPM CONGO, 2019a). The national order of health professions ensures that pharmacists adhere to the code of ethics and set standards established. Per the national pharmaceutical policy, there are plans to develop regulations regarding pharmaceutical and biomedical profession (Ministère de la Santé et de la Population, 2004). There is an indication of the lack of qualified pharmacists and other health professionals (Makinen et al., 2012). There is no information regarding the processes undertaken to license a pharmaceutical establishment as well as the software involved.