- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
4.8 Notification of the trial or submission to the drug regulatory authority
As governed by national regulations, the investigator, sponsor, or investigator jointly with the sponsor, should give notification of the trial to, or obtain approval from, the drug regulatory authority. Any submission to the drug regulatory authority should be in writing and dated, and contain sufficient information to identify the protocol.