Democratic Republic of Congo (DRC): Drugs
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
3 clinical trials approved from July 2012 to July 2014.
Product Registration Data Requirements
According to USAID's Assessment "Assessing the Procurement, Distribution, and System-Strengthening Needs for the Pharmaceutical System in the Democratic Republic of the Congo, October 2008," drug registration is governed by ministerial order 1250/CAB/MINIS/AJ/MS/013/2011 (issued December 9, 2001).
The dossier should include:
-Chemical and pharmaceutical data for the active ingredient, formulation report, certificate of analysis, and stability report.
-Clinical evidence of effectiveness, and toxicity report.
-Good Manufacturing Practices certificate for the manufacturing facility in the country of origin.
-Registration certificate from the country of origin.
-50 samples of the product to be sold in pharmacies or stores, 2 samples of the product expected to be sold in hospitals.
-Local quality analysis report performed by a laboratory in the DRC.
The dossier is reviewed by an ad hoc committee, and there is no written documentation on the decision-making process. There is also no electronic database of registered products. For new products, registration is first granted for a probationary one year. If no clinical or toxic issues arise during the probationary period, the product is granted full registration, which lasts five years.
Product Registration Costs
Registration fee: USD 375
Laboratory analysis fee: USD 50
Post Registration Pharmacovigilance Requirements
The National Pharmacovigilance Centre (Centre National de Pharmacovigilance) (CNPV) oversees pharmacovigilance in the country. USAID/SIAPS reported during an April 2012 meeting that the CNPV is functional. There is, however, no national guidelines and there is low reporting and utilization of pharmacovigilance data. The National Pharmacy Policy of 2005 is supposed to outline pharmacovigilance policy, but is currently unavailable. With the assistance of USAID/SIAPS, CNPV publishes a quarterly newsletter on its pharmacovigilance work. The most recent issue, published July 2013, is available here.
September 30, 2014.