New Clinical Trials Law

On 6 March, 2026, Law No. 9/2026 was published, which ensures the implementation, in the Portuguese legal system, of Regulation (EU) No. 536/2014, of 16 April 2014, on clinical trials on medicinal products for human use.

Scope and Framework

The law establishes the regime applicable to the approval processes and the conduct of clinical trials of medicinal products for human use, repealing the legislation previously in force.

In practice, this means that:

• Clinical trials are now regulated exclusively by the European Clinical Trials Regulation ("Regulation") and by this new Law No. 9/2026.

• Observational studies of medicinal products remain regulated by Law No. 21/2014, of 16 April ("Clinical Research Law").

Legal updates?

In general terms, the new law (finally) aligns the Portuguese legal system to the European regulatory framework, ensuring that the legislation reflects the procedures that were already fully operationalized in Portugal (and in the EU).

Thus, we highlight:

• Regulation of the centralized procedure: the new Law regulates the centralized procedure for authorizing (and amending) clinical trials, reflecting the use of the CTIS (Clinical Trials Information System) platform, operational since 2022 and mandatory since 2023.

• More detailed rules for the protection of participants: reflecting the Regulation, the new Law contains more detailed rules on matters of informed consent, in particular with regard to minors.

• Civil liability and insurance: although the obligation to take out insurance is maintained, in low-intervention clinical trials the law permits the CEIC to waive the requirement for specific insurance, provided that the sponsor submits a declaration of general civil liability insurance covering the relevant damages. The practical scope of this dispensation remains to be clarified.

• Mononational clinical trials: the new Law provides that the member of the Government responsible for the health area may, by ministerial order issued for the purpose, reduce the maximum deadlines provided for in the Regulation for clinical trials carried out in centers located exclusively in national territory.

• Supply of the medicinal products after the conclusion of the trial: the new Law reinforces the sponsor´s obligation, after the conclusion of the trial, to provide the investigational medicinal product available free of charge to the trial subject until its effective introduction into the distribution sector and to ensure its access in the establishments of the National Health Service ("SNS"), thereby giving legal force to what had already been the CEIC’s understanding on this matter.

• Linguistic Requirements: submission documents may be filed in either Portuguese or English, even if the documents intended for the participants and the synopsis of the protocol must always be in Portuguese, except in exceptional cases approved by the CEIC.

• Sanctioning regime: the new Law also establishes a specific inspection and sanctioning regime for the new procedures and obligations arising under the Regulation, while maintaining the structure and amounts of fines previously in force.

• Fees:  it is also worth noting the intention to issue a new fee schedule by ministerial ordinance, maintaining, until then, in force, Ordinance no. 63/2015, of 5 March.

Renewed intention to invest in Clinical Research

It is also worth mentioning the renewal of the intention to invest in clinical research in Portugal, resulting from the new clinical trials law a commitment by the Ministry of Health to adopt, promote and implement the necessary measures to equip trial centers with existing management tools – through the establishment of "Research Centers" and "Integrated Responsibility Centers",  both already provided for and regulated at a legal level.

It is true that this commitment of the Ministry of Health is not new and has already been reflected in prior Orders. In any case, the underlying idea, which remains current, is to improve processes and procedures in public clinical trial centers and thereby increase Portugal's attractiveness for conducting clinical trials.

Entry into force and Transitional Regimes

The Law enters into force 30 days after its publication, that is, on April 5, 2026.

We note that, in any case, the terms and conditions of continued treatment adopted on the date of the respective authorization apply to clinical trials authorized before the entry into force of this law.

What changes in practice?

In practice, the changes introduced by Law No. 9/2026 will mainly have a more formal than substantial scope. Since the European Regulation on clinical trials became applicable, the procedures and requirements provided for in it had already been followed in Portugal. Thus, many of the mechanisms now reflected in national law were already part of the functioning of the system.

In this context, the new Law essentially works as an exercise in aligning the national legal framework with the European regime in force and as an incentive to the growth of clinical trials in Portugal, which we hope will materialize.