Burkina Faso | Senegal |
Law No. 23/94/ADP of May 19, 1994 on Public Health Code | Law 54-418 of April 15, 1954 on Book V pharmacy |
Law n˚ 2009-17 of March 09, 2009: Code of ethics for health research (CEHR) | |
Decree No. 2002-536/PRES/PM/MS/MESSRS of November 21, 2002 on Ethics Committee for Health Research (ECHR); Decree No. 2010-243/PRES/PM/MS of May 20, 2010 regulating clinical trials; Decree No. 2012-1033/PRES/PM/MS of December 28, 2012 on National Vigilance System for Health Products for Human Use. | Decree n˚ 2009-729 of August 3, 2009: Creation, organization and functioning of National Ethics Committee for Health Research (NECHR) |
Joint Order No. 2004-147/MS/MESSRS of May 11, 2004 on the organization and operation of the ethics committee for health research in Burkina Faso (ECHR). Order No. 2010-292/MS/CAB of October 1, 2010 on the condition for granting authorizations for clinical trials; Order No. 2010-293/MS/CAB of October 7, 2010 on composition and operation of Technical Committee for examination of clinical trial authorization applications (TCEC). | Order No. 2009–5036/MSP/DPL of April 22, 2009 on the organization of the national pharmacovigilance system. Order No. 2011-014299/MSPHP/DPL of December 15, 2011 on the adoption of good clinical practices (GCP ICH) for the conduct of clinical trials; Order No. 2013-409 of January 22, 2013 adopting the researcher’s guide and the brochure for (NECHR) members for the evaluation and monitoring of research protocols. |
Decision no. 2013-980/MS/CAB of August 16, 2013 appointing the members of the technical committee for examining applications for authorization of clinical trials (TCEC). | The members of the (NECHR), before their official entry into office, take an oath before the Court of Appeal of Dakar, sitting in solemn audience. |