Sierra Leone Profile Updated
The Sierra Leone profile in ClinRegs has been reviewed and updated with the following information:
- Updated Sierra Leone Ethics and Scientific Review Committee application guidelines (See Scope of Review, Ethics Committee Fees, Clinical Trial Lifecycle topic, and Documentation Requirements)
- Updated Pharmacy Board of Sierra Leone (PBSL) fees (See Regulatory Fees)
- PBSL requirements from 2024 regarding pharmaceutical product import (See Manufacturing & Import)
- Reference to 2024 PBSL guidance on bioequivalence studies (See Scope of Assessment)
- Updated PBSL guidelines, which underwent minor formatting changes (See Requirements)
Sources Added During this Update:
(Guidance) Guideline on the Investigation of Bioequivalence (G-SLBioequiv) (Version No. 02) (Effective May 17, 2024)
Pharmacy Board of Sierra Leone
(Guidance) Guidelines for the Importation and Clearance of Pharmaceutical Products at the Official Port of Entry (G-SLImport) (Version No. 03) (Effective May 17, 2024)
Pharmacy Board of Sierra Leone
(Webpage) Pharmacy Board of Sierra Leone - Registration Fees (SLE-10) (Current as of March 26, 2026)
Pharmacy Board of Sierra Leone
Sources Revised During this Update:
(Guidance) A Guide for Safety Monitoring of Medicines in Sierra Leone (G-SLSftyMntrng) (Version No. 03) (Effective May 17, 2024)
Pharmacy Board of Sierra Leone
(Guidance) Good Clinical Practice Guidelines (SL-GCP) (Version No. 03) (Effective May 17, 2024)
Pharmacy Board of Sierra Leone
(Guidance) Guide for the Inspection of Clinical Trials (G-SLInspect) (Version No. 03) (Effective May 17, 2024)
Pharmacy Board of Sierra Leone
(Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements in Sierra Leone (G-SLAppClinTrial) (Version No. 03) (Effective May 17, 2024)
Pharmacy Board of Sierra Leone
(Guidance) Guidelines for Registration of Biosimilar Products (G-SLBiosimilar) (Version No. 03) (Effective May 17, 2024)
Pharmacy Board of Sierra Leone
(Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (2025)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health, and Directorate of Training and Research