- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
- Keywords > clinical trials
- Keywords > clinical trials - social, legal and ethical implications
- Keywords > clinical trials in humans
- Keywords > controlled clinical trials
- Keywords > ethical practices and standards
- Keywords > GCP for trials on pharmaceutical products
- Keywords > Good Clinical Practice (GCP)
- Keywords > investigational product - clinical trials
- Keywords > WHO expert committee
(1995; 36 pages) [French] [Spanish]
11. ROLE OF THE DRUG REGULATORY AUTHORITY
The role of governments is to provide the legal framework for clinical trials. The aim should be twofold: (i) to protect the safety and rights of the subjects participating in a trial, and (ii) to ensure that trials are adequately designed to meet scientifically sound objectives. These aims may be met by several means, including the specification of the investigator’s qualifications and requirement for review and approval of the protocol by relevant scientific and/or ethics committees.
Drug regulatory authorities should have a mandate to review protocols and, where necessary, to protect the safety of subjects, to require protocol revisions and/or termination of trials.
Regulations should allow for on-site inspections of the quality and reliability of the data obtained, with due concern for confidentiality.