Sierra Leone Profile Updated

October 31, 2022
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The Sierra Leone profile in ClinRegs has been reviewed for accuracy and updated with the following information:

  • New good clinical practice guidelines for drug trials involving human participants, which was incorporated throughout the profile
  • Updated Pharmacy Board of Sierra Leone (PBSL) fees for foreign-sponsored clinical trials (See Regulatory Fees)
  • Guidelines related to biosimilar product registration, development safety update reports, and PBSL clinical trial inspections (See Scope of Assessment, Safety Reporting, and Risk & Quality Management)

Sources Added During this Update:

(Guidance) A Guide for Safety Monitoring of Medicines in Sierra Leone (G-SLSftyMntrng) (Version 02) (Effective February 17, 2021)
Pharmacy Board of Sierra Leone

(Guidance) Guide for the Inspection of Clinical Trials (G-SLInspect) (Version 02) (Effective February 17, 2021)
Pharmacy Board of Sierra Leone

(Guidance) Guidelines for Registration of Biosimilar Products (G-SLBiosimilar) (Version 02) (Effective February 17, 2021)
Pharmacy Board of Sierra Leone

Sources Revised During this Update:

(Guidance) Good Clinical Practice Guidelines (SL-GCPs) (Version 02) (Effective February 17, 2021)
Pharmacy Board of Sierra Leone
 

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