The Directorate of Pharmacy, Medicines and Traditional Medicine is the drug regulatory authority oversees medicines regulation and is responsible for keeping the National Medicines Registry up to date. The regulatory body is also responsible for ensuring that the country is compliant with the requirements of the World Health Organization’s Prequalification of Medicines Program. This program helps ensure that medicines supplied by international procurement agencies for distribution in countries with limited resources meet acceptable standards of quality, safety, and efficacy.
In December 2017, the Global Health Supply Chain Technical Assistance Francophone Task Order provided technical and financial support to the Drug Regulatory Authority of the DRC to review the Medicines Registry authorized for use in the country. The review identified that half of all the authorizations (2,322) issued in the period of January 2010 to September 2017 were expired. Additionally, 109 market authorizations were identified to expire within three months after the review (USAID Global Health Supply Chain Program, 2018).
SIAPS also supported the DRA to implement a pharmaceutical regulatory system and develop a comprehensive national pharmaceutical policy framework. The National Essential Medicine List, which included 13 lifesaving commodities endorsed by the UN Commission on Life-Saving Commodities for Women’s and Children’s Health, was updated (SIAPS, 2016).