Clinical Trial Application
The conduct of clinical trials in Portugal requires prior authorization of INFARMED, IP and favorable opinion of the National Ethics Committee for Clinical Research (CEIC).
The clinical trial applications shall be submitted to both INFARMED, IP and CEIC through RNEC platform, according to the applicable legal requirements and after payment of the applicable fee through the gateway provided by the RNEC platform.
Regarding the INFARMED, IP and CEIC decision timelines, the Law No. 21/2014 of 16 April lay down a shorter period than the clinical trials directive maximum timeframe) establishing 30 working days for commencement of clinical trials (INFARMED, I.P. - article 26, and CEIC - article 16) and 20 working days for authorization of substantial amendments (INFARMED, I.P. and CEIC - article 18).
However, different legal timeframes are set for clinical trials involving (articles 27 and 17):
- i) medicinal products of gene therapy, ii) medicinal products of somatic cell therapy and iii) medicinal products which contain genetically modified organisms: the period of 30 working days may be extended for further 20 working days. In the case of consultation of expert groups or committees, the timeframe may be extended for further 50 working days.
- Xenogenic cell therapy - not subject to any legal timeframe.
The approval process of clinical trials in Portugal by INFARMED, I.P. and CEIC can be summarized in the next flowcharts:
- Flowchart for the Approval Process of a Clinical Trial by INFARMED, I.P.
- Flowchart for the Approval Process of a Clinical Trial by CEIC.
The fees to be paid for the services provided within the scope of the Law No. 21/2014 of 16 April are established by ordinance no. 63/2015, of 5 March. The payment of fees should be made via RNEC portal.
In accordance with the article 3 of ordinance no. 63/2015, of 5 March, a fee exemption may be granted by INFARMED, I.P. management board if the sponsor is a non-profit entity and/or in the case of non-commercial clinical trials.
In order to request fee exemption, the sponsor must submit to the management board of INFARMED, I.P. the applicable statute or regulation form the institution specifying its non-commercial / non-profit nature, prior to the submission of the clinical trial application through RNEC. A declaration signed by the head of the institution clarifying that the study has no commercial purpose may also be applicable for this purpose.
In situations in which the payment of the fee has already take place, reimbursement through the RNEC Portal upon exemption proof may also apply.
Applicable regulation to the submission of a Clinical Trial application, notification of substantial amendment, notification of end of trial, notification of final report and other notifications:
- Law no. 21/2014, of 16th April, modified by Law no. 73/2015, of 27th July
- Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (CT-1)
- Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use (CT-2)