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Sierra Leone
GUIDELINES FOR APPLICATION & AUTHORISATION OF CLINICAL TRIALS OF MEDICINES, VACCINES, MEDICAL DEVICES -SIERRA LEONE
These guidelines, issued by the Pharmacy Board of Sierra Leone (PBSL), set the procedural and documentation standards for all applications to conduct clinical trials involving medicines, vaccines, medical devices, and food supplements. It specifies mandatory requirements for the submission dossier, including the protocol, Investigator’s Brochure, and application fees. The document details the roles of the Principal Investigator (PI) and the required supervision of Investigational Medicinal Products (IMP) by a qualified pharmacist. Furthermore, it provides the fee schedule, which is differentiated by trial phase and funding source.
Use Cases
- Sponsors – Obtain Authorization: They must submit a formal application, including a cover letter, application fees (e.g., USD 15,000 for Phase I industry-funded trials), and the protocol, to the PBSL.
- Principal Investigators (PIs) – Ensure Medical Supervision: The PI must be a qualified medical practitioner or dentist and is responsible for all trial-related medical (or dental) decisions.
- PIs – Ensure IMP Accountability: The Principal Investigator shall ensure that a qualified pharmacist supervises the management of the Investigational Medicinal Product.
- Applicants – Amend Trial Details: They must seek PBSL approval for substantial amendments to the protocol, which may relate to information relevant for assessment by the PBSL, the Ethics Committee, or both.
- PBSL – Review and Approve/Deny Applications: The PBSL reserves the right to review and approve, reject, or request changes to the application package (protocol, IB, etc.).
- Researchers – Utilize Existing Patient Data: Records or specimens used in clinical care may be used for research without consent only if the ethical review committee determines the risk is minimal, rights are not violated, and research would be impracticable otherwise.
Key takeaways you'll learn
The resource’s purpose is to standardize the application and authorization process for clinical trials in Sierra Leone, ensuring regulatory compliance, subject safety, and scientific integrity across all types of health product investigations.
- Broad Scope of Regulation: The guidelines regulate trials involving not just medicines and vaccines, but also medical devices and food supplements.
- Mandatory Pharmacist Oversight: It is a specific requirement that a qualified pharmacist supervises the management of the Investigational Medicinal Product.
- Differentiated Fee Structure: Application fees are tiered based on the phase of the trial (Phase I, II, III) and the funding source (industry-funded vs. investigator/research institution funded).
- Strict Financial Declaration: A Joint Financial Declaration by the Sponsor and Principal Investigator is required to confirm that sufficient funds are available to complete the study.
- Waiver of Consent Conditions: Informed consent may be waived for the use of clinical care data/specimens for research only if an ethical review committee explicitly deems the risk minimal and the research impracticable otherwise.
