- All > Quality and Safety: Medicines > Quality Assurance
- All > Quality and Safety: Medicines > Regulatory Support
- Keywords > Clinical Trial Import Licence (CTIL)
- Keywords > clinical trials
- Keywords > clinical trials - social, legal and ethical implications
- Keywords > clinical trials conducted - new medicines approved/New Drug Application (NDA)
- Keywords > clinical trials in humans
- Keywords > GCP for trials on pharmaceutical products
- Keywords > marketing authorization
- Keywords > registration of medicinal products
- Keywords > registration of pharmaceuticals
- Keywords > safety and efficacy
- Keywords > enregistrement des médicaments
(2013; 14 pages)
The purpose of Drug Registration is to ensure that a pharmaceutical product has been adequately tested and evaluated for safety, efficacy and quality, and that the product information provided by the manufacturer is accurate. It also allows the pharmaceutical product to be placed on the market until the registration period for the product has expired. The Pharmacy Board of Sierra Leone has developed and adopted the following guidelines: Guidelines for conducting clinical trials of medicinal products and vaccines.(Please note that this guideline is only applicable for new drug entity).
These guidelines are intended to facilitate the registration process of Pharmaceutical products, and are meant to be adopted and implemented by all stakeholders intending to market Pharmaceutical products in Sierra Leone.
The overall goal of these guidelines is to achieve the highest practicable standards of the quality of products imported into Sierra Leone and in addition to ensure the safety, quality and efficacy for these products including manufactured, imported, exported and distributed to ensure the protection of the public health as envisaged by the Pharmacy and Drugs Act.
It should be noted however, that these guidelines are subject to review as and when necessary by the Pharmacy Board of Sierra Leone.