- Tous > Quality and Safety: Medicines > Quality Assurance
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- Mots-clés > Clinical Trial Import Licence (CTIL)
- Mots-clés > clinical trials
- Mots-clés > clinical trials - social, legal and ethical implications
- Mots-clés > clinical trials conducted - new medicines approved/New Drug Application (NDA)
- Mots-clés > clinical trials in humans
- Mots-clés > GCP for trials on pharmaceutical products
- Mots-clés > marketing authorization
- Mots-clés > registration of medicinal products
- Mots-clés > registration of pharmaceuticals
- Mots-clés > safety and efficacy
- Mots-clés > enregistrement des médicaments
(2014; 32 pages)
In pursuance of Section 55 of the Pharmacy and Drugs Acts, these Guidelines are hereby made by the Pharmacy Board of Sierra Leone (PBSL), hereafter referred to as The Board, to define the general norms and scientific principles and to set applicable standards for the conduct, performance and control of clinical trials in human beings in Sierra Leone particularly in relation to granting of marketing authorization. They do not cover veterinary trials.
These Guidelines are addressed to investigators, pharmaceutical manufacturers and other sponsors of clinical trials whether for academic purposes or for generation of data intended for inclusion in the regulatory submissions for medicinal products. They are intended to be applied during all stages of drug development both prior to and subsequent to product registration and marketing.
Clinical trials shall be categorized as follows;
1. Trials initiated by The Board.
2. Trials initiated by pharmaceutical companies or agencies.
3. Trials initiated by pharmaceutical companies on advice of The Board, to be carried out locally for pharmacogenetic or other reasons peculiar to the population in Sierra Leone.
4. Trials initiated by academic and research institutions either locally or as part of an international multicentre study.
In all the categories above the primary end-point of the trial shall be clearly specified.