- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
5.5 Safety information
The sponsor must inform the investigator(s) promptly of any immediately relevant information on safety that becomes available during a clinical trial and ensure that the ethics committee and the drug regulatory authority are notified by the investigator(s) if required (see Section 7).