Médicaments : le Sames/Arp clarifie la procédure d'autorisation de mise sur le marché
In a press release published on Friday, February 20, the national executive office of Sames/Arp (Senegalese Pharmaceutical Regulatory Agency) provided clarifications regarding the text describing as a "false alarm" the concerns expressed concerning the holding of the National Medicine Commission (CNM) on February 16 and 17, 2026.
The executive office recalled that the Marketing Authorisation (MA) procedure is governed by Regulation No. 04/2020/CM/UEMOA, which imposes a clear sequence: prior scientific evaluation by experts from the Technical Committee, preparation of reasoned technical reports, then administrative decision by the competent Commission.
The unions also emphasized that recruiting agents to support the evaluation of MA files cannot replace the formal holding of a session of the Technical Committee of Experts. "The meeting of this Committee is a regulatory requirement enshrined in Regulation No. 04/2020/CM/UEMOA and the national provisions in force," the statement reads.
According to them, prior scientific evaluation is a mandatory step to guarantee the quality, safety and efficacy of medicines, and constitutes the basis for the protection of public health.
Finally, the national executive office of Sames/ARP reaffirmed its commitment to respecting the hierarchy of standards and ensuring the legal soundness of marketing authorization decisions, as well as the credibility of the national pharmaceutical regulatory system.
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