Portugal’s New Clinical Trials Law No. 9/2026: What Sponsors Need to Know

Portugal has formally updated its national legal framework for clinical trials on medicinal products for human use through Law No. 9/2026 of 6 March, the third amendment to Law No. 21/2014 of 16 April, fully aligning it with the EU Clinical Trials Regulation (CTR) 536/2014. This update clarifies how clinical trials are authorized, conducted, and supervised across the country and provides sponsors with a clear and harmonized framework.

Here is what changes for sponsors.

KEY TAKE AWAY

On March 6, 2026, Portugal published Law No. 9/2026, which implements the EU Clinical Trials Regulation (CTR) No. 536/2014 at national level and establishes the specific legal framework for clinical trials on medicinal products. It enters into force on April 5, 2026. For sponsors planning clinical trials in Portugal, this means a clearer regulatory framework, a formalized dual-authority approval model (INFARMED for scientific assessment and CEIC for ethical review), and new obligations around post-trial access and liability insurance.

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Why Law No. 9/2026 Matters?

The EU Clinical Trials Regulation (CTR) 536/2014 has been in force since January 2022, and since January 2025 all new clinical trial applications in the EU must be submitted through the Clinical Trials Information System (CTIS). However, each Member State still needs national implementing legislation to define the specific roles of competent authorities and ethics committees, and to establish local rules on participant protection, insurance, and sanctions.

Portugal’s previous framework for clinical trials was built on Law No. 21/2014, the Clinical Research Law, which transposed the older EU Clinical Trials Directive (2001/20/EC). While the CTR itself is directly applicable across the EU, there were aspects of national implementation that remained unresolved in Portugal, until now.

Law No. 9/2026 constitutes the third amendment to the Clinical Research Law and establishes the complete legal framework for conducting clinical trials on medicinal products for human use in Portugal under the EU regulation.

“The new Clinical Trials Law updates the Portuguese framework to fully align with the EU Clinical Trials Regulation, reinforcing the roles of INFARMED and CEIC and requiring an integrated scientific and ethics assessment before trial authorization.”

Catarina Pragana, Clinical Research Manager, MDx CRO

Importantly, this is not an isolated development. In December 2025, Portugal also approved Law No. 71/2025, which transposes the MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) into national law for all matters relating to clinical investigations of medical devices and performance studies of IVDs. Together, these two laws signal Portugal’s intention to modernize its entire clinical research ecosystem.

Key Provisions of Law No. 9/2026

1. INFARMED and CEIC: Roles Formalized

The law formally establishes the dual-authority model that the CTR requires at the national level:

Regulatory Responsibilities Under Law No. 9/2026

• INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde) is designated as the competent authority responsible for scientific and technical assessment, the national point of contact under the CTR, and the entity issuing the final authorization decision.
• CEIC (Comissão de Ética para a Investigação Clínica) is designated as the ethics committee responsible for assessing ethical aspects of clinical trial applications, including recruitment materials, informed consent procedures, and evaluation of the study team. CEIC issues a binding opinion.

INFARMED consolidates both assessments and makes the final authorization decision, which must be based on the results of the scientific evaluation and CEIC’s binding ethics opinion.

CEIC may also delegate certain assessments to local Health Ethics Committees that are part of the national network, as long as the requirements of Article 9 of the CTR are observed.

According to Ana Sofia Silva, Clinical Research Specialist at MDx CRO, this clearer structure is a positive development:

“This new structure could speed things up by reducing duplicated communication and paperwork between CEIC and INFARMED. A clearer division of responsibilities usually helps streamline the process”.

2. Submission Through CTIS

All clinical trial applications, including requests for substantial amendments, must be submitted through the EU CTIS portal. As Catarina Pragana notes, “For clinical trials involving medicinal products, all submissions now run through CTIS, the central European system. INFARMED reviews the scientific and technical components, while CEIC is responsible for the ethics assessment.”

INFARMED is responsible for ensuring the coordination between CTIS and Portugal’s existing Registo Nacional de Estudos Clínicos (RNEC), so that national clinical trial information remains integrated and publicly accessible.

For sponsors already familiar with CTIS from other EU markets, this is a familiar process. The key point is that Portugal’s national validation and assessment procedures now fully align with the timelines and workflows established in the CTR.

3. Participant Protection and Informed Consent

Law No. 9/2026 establishes detailed provisions for protecting trial participants that go beyond the general CTR framework:

Informed Consent Rules

• Minors aged 16+: Their written assent is required in addition to consent from a legal representative. For minors under 16 who can understand the information, their assent must also be obtained (in any form).
• Emergency inclusion: Participants facing serious or immediate risk to life may be enrolled without prior consent if the research directly relates to their clinical situation, the protocol has been pre-approved by an ethics committee, additional risks are minimal, and consent is obtained as soon as possible afterwards.
• Incapacitated adults and minors in institutional care: Cannot be enrolled in clinical trials except when non-participation would result in a potential disadvantage to them.
• Cluster trials (mononational only): Simplified consent procedures may be used for Portugal-only trials, subject to CEIC approval, when the conditions of Article 30 of the CTR are met.

4. Post-Trial Access Obligations

One of the most sponsor-relevant provisions of the new law is Article 14, which establishes a legally binding obligation for sponsors to continue providing investigational medicinal products free of charge after the trial ends.

This obligation applies only if the investigator considers that continued treatment is indispensable for the participant and no therapeutically equivalent alternatives of comparable efficacy and safety are available. The obligation continues until the product becomes accessible through Portugal’s National Health Service (SNS).

Ana Sofia Silva offers a nuanced perspective on what this means in practice:

“Although Article 14 introduces post-trial access requirements, these apply only when the investigator considers that continued treatment is indispensable and no equivalent alternatives exist. This approach is stricter than in most EU countries, where post-trial access is generally addressed through ethics guidance rather than binding national legislation. Since the continuation only applies in clinically justified scenarios, I do not expect it to be a major setback for most sponsors.”

5. Liability Insurance

Sponsors and investigators bear joint and strict liability (independent of fault) for both material and non-material damages caused to trial participants. The law requires mandatory civil liability insurance, though CEIC may waive the requirement of a trial-specific policy for low-intervention trials if the sponsor can demonstrate existing coverage.

An important provision establishes a presumption of causality: any adverse health effects experienced by a participant during the trial or within one year after the end of participation are presumed to be related to the trial, unless proven otherwise. CEIC may extend this period depending on the nature and risk profile of the study.

6. Language Requirements

Understanding the language rules is critical for sponsors preparing their dossier:

Document Type	Language Required
Technical dossier (scientific sections)	Portuguese or English
Informed consent forms & participant-facing materials	Portuguese (mandatory)
Lay summary of trial results	Portuguese (mandatory)
Protocol synopsis (Annex I, Section D.24)	Portuguese (mandatory)
IMP / auxiliary medicinal product labeling	Portuguese (mandatory); English accepted if products are only handled on-site

7. Penalty Framework

The law establishes a sanctions regime that sponsors should factor into their compliance planning:

Key Penalties Under Law No. 9/2026

• Individuals: Fines from €500 to €50,000
• Companies: Fines from €5,000 to €750,000
• Additional sanction: Suspension or prohibition of conducting clinical trials for up to 2 years

Violations include: conducting a trial without authorization, failing to report safety events, non-compliance with GCP, conducting a trial without mandatory insurance, and failing to comply with post-trial access or language requirements.

“Sponsors should always factor potential penalties into their risk planning. But the violations mentioned, running a trial without authorization or not reporting safety events, are serious deviations that should never occur in a well-managed study. Although Portugal’s maximum fines are higher than in many EU countries, similar penalty systems exist across the EU, since all Member States must establish sanctions under the Clinical Trials Regulation.”

Ana Sofia Silva, Clinical Research Specialist, MDx CRO

Practical Impact for Sponsors: What This Means on the Ground

The Approval Workflow

Under the new law, the end-to-end authorization process for a clinical trial in Portugal follows a clearly defined path:

Step-by-Step: Clinical Trial Authorization in Portugal

• Step 1. Submission via CTIS: The sponsor submits the application dossier through the EU portal, including all elements required by Annex I of the CTR.
• Step 2. Validation: INFARMED validates the dossier completeness, consulting CEIC on the elements within its scope (sections K, L, M, N, O, P, and R of Annex I).
• Step 3. Assessment: INFARMED assesses the scientific/technical aspects (Part I). CEIC assesses the ethical aspects (Part I ethical elements + Part II).
• Step 4. Consolidation: INFARMED consolidates both assessments within CTR timelines.
• Step 5. Decision: INFARMED issues the final authorization decision, based on the consolidated assessment and CEIC’s binding opinion.

Contract Requirements

The law requires sponsors to execute a contract with each clinical trial site that covers the financial arrangements and other terms referenced in Section P of Annex I of the CTR. These terms are assessed as part of the authorization procedure. The contract can be finalized before, during, or immediately after the authorization notification, but it only takes effect after authorization is granted.

A Competitive Edge: Shorter Timelines for Mononational Trials

Article 30 of Law No. 9/2026 authorizes the Portuguese government to set maximum timelines that are shorter than those established in the CTR for clinical trials conducted exclusively in Portugal. While the specific reduced timelines are yet to be defined by ministerial order, this provision creates a potential competitive advantage for attracting single-country studies to Portugal.

“I think shorter timelines for mononational trials could be seen as a competitive advantage for Portugal.”

Ana Sofia Silva, Clinical Research Specialist, MDx CRO

Fee Exemptions

Non-commercial clinical trials and investigator-initiated trials are exempt from the assessment fees. Until the new fee schedule is published (expected via ministerial order within 30 days of the law’s entry into force), the existing fees from Portaria 63/2015 remain applicable.

Portugal as a Clinical Trial Destination: The Bigger Picture

Law No. 9/2026 does not exist in isolation. Over the past two years, Portugal has been building a more comprehensive and attractive framework for clinical research:

The pattern is clear: Portugal is modernizing its regulatory infrastructure across both pharmaceuticals and medical devices simultaneously. The creation of AICIB (Agência de Investigação Clínica e Inovação Biomédica) and the launch of the Portugal Clinical Studies platform are additional signals that the country is actively positioning itself to attract more international clinical research.

“Interest seems to be increasing compared to a few years ago, although there is still work to do to make the country more competitive overall.”

Ana Sofia Silva, Clinical Research Specialist, MDx CRO

Practical Considerations: What Sponsors Should Know

Portugal is becoming an increasingly attractive destination for clinical trials thanks to a more streamlined and transparent regulatory framework. However, beyond regulatory improvements, sponsors should carefully consider key operational factors to ensure successful study execution.

According to Ana Sofia Silva, the Portuguese clinical research landscape still shows a stronger familiarity with traditional drug trials compared to medical device (MD) and in vitro diagnostic (IVD) investigations. This means that when MD or IVD studies are introduced, clinical sites may require additional guidance and support, as these types of studies are less common in the local market.

Another important factor is the contracting process with Portuguese hospitals, which can be slower than expected. This can have a direct impact on study timelines, making early planning essential for sponsors aiming to avoid delays.

Our Clinical Research Specialist highlights three key recommendations for sponsors planning clinical trials in Portugal under the new regulatory framework:

• Take advantage of a more efficient approval process: The updated INFARMED and CEIC structure is designed to streamline submissions and accelerate approvals.
• Start site selection and contracting early: Given the potential delays in hospital agreements, early initiation of these processes is critical.
• Plan realistic budgets and site support: Many clinical sites face staffing constraints, so adequate compensation per participant and proper resource allocation are essential to maintain engagement and performance.

By aligning regulatory expectations with operational realities, sponsors can better position their clinical trials for success in Portugal, optimizing both timelines and site collaboration.

What Sponsors Should Do Now Portugal’s New Clinical Trials Law

With the law entering into force on April 5, 2026, sponsors planning or conducting clinical trials in Portugal should take several practical steps:

1. Review your internal procedures to ensure alignment with the new dual-authority model (INFARMED for scientific assessment, CEIC for ethics).
2. Ensure your CTIS workflows account for Portugal-specific validation requirements, particularly CEIC’s role in validating Annex I sections K through R.
3. Check your insurance coverage mandatory civil liability insurance is required, with a one-year post-trial presumption of causation.
4. Prepare Portuguese translations of all participant-facing materials, including informed consent forms, lay summaries, and labeling.
5. Budget for post-trial access obligations particularly when no suitable therapeutic alternatives to the investigational product are available in Portugal.
6. Begin site qualification and contracting early hospital contracting in Portugal can be slow, and many sites face resource constraints.
7. Monitor secondary legislation the new fee schedule and IMP manufacturing requirements are expected via ministerial order in the coming weeks.

Frequently Asked Questions