Clinical Trial Data Requirements
According to the National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS), no clinical trial application is submitted to the Regulatory Authority. Clinical trial authorization is received through the national ethics committee, Conseil National de Recherche en Santé (CNRS). Approval from the CNRS is necessary for a clinical trial to begin. Prior to submitting an application, the Principal Investigator (PI) or coordinating PI must pay fees to the CNRS. The CNRS meets monthly, and assess 3-4 applications. Documents must be submitted to the CNRS secretary at least three weeks prior to the meeting. Within 1 week after the meeting, CNRS will send comments to the applicant.
The dossier must include:
-a cover page
-an initial page (full title of the study, protocol synopsis)
-protocol (including how the study fits into the Nationla Plan for health research)
-curriculum vitae of PI
-power of attorney
All documents must be submitted in French, with the exception of the Insurance Certificate, which can be in English. 25 hard copies must be submitted, in addition to an electronic copy sent to email@example.com
Clinical Trial Import Authorization
Import authorization can be requested from the Regulatory Authority after the CNRS opinion is given. Documents required for an importation license include the CNRS opinion, proforma invoice, certificate of analysis, and delivery note.
Clinical Trial Estimated Timeline
According to the National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS), approval takes a few days to one week.
Clinical Trial Costs
250,000 FCFA/382 euros.
In-Country Manufacturing Requirements
Compliance with International Conference on Harmonisation (ICH)/European Medicines Agency (EMEA) Good Manufacturing Practices (GMP).
Insurance is required, and proof of insurance must be submitted with the dossier. There is no specific requirements on the indemnity.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
3 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
A drug registration dossier requires:
-the name and address of the company/manufacturer
-complete description of the project
-registration tax of 250,000 FCFA.
Applications can be submitted in French or English. More information is available here.
Product Registration Costs
If products is manufactured in Senegal, the fee is 200,000 FCFA. Otherwise, registration costs 250,000 FCFA. Renewal of registered products is 125,000 FCFA.
Post Registration Labeling Requirements
No specific country requirements, although it is recommended that ICH guidelines are followed.
Post Registration Pharmacovigilance Requirements
A national pharmacovigilance system was created in 1998, but did not become active until 2007. The pharmacovigilance system is composed of a technical committee (which conduct causality assessments) and a national pharmacovigilance commission (which gives guidance to the Minister). There is also a pharmacovigilance focal person in every medical region or district. The system is challenged by a lack of manpower, funds, health worker capacity, and motivation to report. Subsequently, reporting data is of poor quality.
According to the National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS), regulatory laws do not specify safety reporting requirements so adherence to ICH GCP guidelines are recommended. The PI is responsible for submitting adverse event reports to the Regulatory Authority and CNRS.
September 23, 2014.