CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Ministry of Health/ Competent Authority
Ethics committee(s)

CA - Submission for authorisation mandatory for

Clinical trials conducted in humans, including studies to investigate bioavailability and bioequivalence, with drugs, medicinal and biological products, or herbal medicinal products, whether authorized or licensed, and for observational drug studies.

CA - Submission required to

National CA
Relevant EC(s)

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