The pharmaceutical regulatory environment in Senegal is undergoing profound changes with the strengthening of the powers of the Pharmaceutical Regulatory Agency (ARP). For laboratories and manufacturers of medical devices, understanding these changes is key to avoiding customs blockages and approval delays.
1. The Digitalization of Procedures
One of the major reforms is the gradual shift to digital submission.
- Impact: Increased traceability of files.
- MedBridge Tip: Ensure your documents (Pharmaceutical Product Certificates, CTD dossiers) are scanned in high resolution and conform to the required formats to avoid automatic rejection at the pre-submission stage.
2. New Requirements for Medical Devices
Medical devices (consumables, hospital equipment), long less regulated than pharmaceuticals, are now subject to strict controls.
- New requirement: Clinical evidence and conformity certificates (ISO/CE) less than 5 years old are now mandatory.
- Risk: Without approval compliant with the new nomenclature, no product can participate in PNA tenders.