Regulation of clinical trials of medicinal products for human use and amendment of the clinical investigation law

Law No. 9/2026 was published in the Portuguese Official Gazette on 6 March 2026 establishing the new national regime applicable to clinical trials of medicines for human use, ensuring the implementation of Regulation (EU) No 536/2014 and making the third amendment to Law No 21/2014, which approved the clinical research law.

The Law represents an essential step towards harmonising the Portuguese regime with the European framework for clinical trials.

Among the main changes is the reorganisation of roles between INFARMED, which assumes decision-making powers and the role of national authority responsible for the purposes of the European Regulation, and the Ethics Committee for Clinical Research, which will now issue the binding ethical opinion required for the authorisation of trials.

The submission procedure is carried out exclusively through the European portal, ensuring a more uniform and centralised process. Simultaneously, the law strengthens the framework for the protection of participants, with detailed guidelines on informed consent, the participation of minors and accompanied adults, emergency situations and the continuity of treatment after the conclusion of the trial, including the free provision of medicines when clinically necessary.

The law also introduces a more robust civil liability regime, imposing joint responsibility on the sponsor and the investigator and requiring the purchase of insurance appropriate to the nature and risk of the trial. It also clarifies the requirements for the manufacture, import, traceability, and labelling of investigational medicinal products. In addition, it creates a specific penalty regime for infringements of the new legal framework, with fines of up to EUR 750,000 in the case of legal persons.

Compared to the previous framework, Law No. 9/2026 significantly modifies Law No. 21/2014, expressly excluding clinical trials of medicines for human use from its scope of application, which is now reserved for other clinical studies not covered by specific European regulations.

The law establishes the following transitional regime: until the publication of the new ordinance on fees, Ordinance No. 63/2015 remains applicable. Law No. 9/2026 takes effect 30 days after its publication, i.e. on 5 April 2026, at which date all new submissions for clinical trials of medicines will be subject to the new regime.