CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)
• Recruiting sites: Administration Board and Local Ethical Committee

CA - Submission for authorisation mandatory for

Clinical IMP trials
Clinical ATMP trials
Drugs; Biologicals including ATMPs; Xenogenic products; GMO

CA - Submission required to

National CA
Infarmed

National trial registry

RNEC (National Registry of Clinical Studies) http://www.rnec.pt/pt
RNEC has a private area with registered users to submit studies and manage the process approval and also a public area where it is possible to search for registered studies in Portugal since January 2017
RNEC (National Registry of Clinical Studies) http://www.rnec.pt/pt
RNEC has a private area with registered users to submit studies and manage the process approval and also a public area where it is possible to search for registered studies in Portugal since January 2017

Additional Information

Detailed guidance for the applicant on trial submission and the definite structure of documentation is provided at INFARMED website. There is a File to be uploaded with all documents that must be submitted “ Estrutura de organização de pastas conforme Instruções ao requerente”.

There is also a Flowchart and Support slides describing the process and the needed documents to be submitted.
All the information is available only in Portuguese.

For further guidance an email is available: ensaios.clinicos@infarmed.pt

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395