Regulatory Submissions

In Cameroon, multiple documents are examined by the regulatory authority prior to granting approval for a clinical study. Sponsors and PIs are expected to develop these documents and submit to the National Ethics Committee and follow up. Once these initial study dossiers are submitted, the National Ethics Committee gives their feedback either as: Approved, Rejected or Additional Data Required.

If ethical clearance is granted, the study cannot commence until an administrative clearance is obtain from the ministry.

To help sponsors get quick approvals the CRENC provides the following services:

• Pre-Approval: Dossiers and Supplements
• Post Approval Requirements:
• Regulatory compliance documentation (variations & renewals)
• Regulatory submissions for extended drug development activities (abridged applications)
• Labelling & PI updates
• Ministerial clearance: We help the PI and the sponsor to submit the administrative clearance once the ethical clearance is obtained.

Prior to these regulatory submissions, research administrative authorizations are carried out at various sites. With the help of experienced, full time clinical research coordinators we help the investigators with all these submissions, documentation and safety reporting following strict timelines.