The attractiveness of the regulatory environment is a key driver of clinical research activity, directly influencing sponsors' decisions on where to initiate and conduct clinical trials. In a context of increasing global competition, the European Union has therefore launched several initiatives aimed at accelerating the authorization of clinical trials, while maintaining high standards of scientific quality, ethics, and participant safety.

A cornerstone of this strategy is the "Accelerating Clinical Trials in the European Union" (ACT EU) initiative, led jointly by the European Medicines Agency (EMA), the European Commission, and the Heads of Medicines Agencies (HMA). ACT EU seeks to modernize the EU clinical trial ecosystem by improving coordination between national competent authorities, enhancing the use of the European Clinical Trial Information System (CTIS), and increasing the efficiency and predictability of assessment procedures, particularly for multinational clinical trials.

Within this framework, the HMA has launched a pilot accelerated approach for multinational clinical trials conducted in the European Union and the European Economic Area, commonly referred to as the "FAST-EU initiative." This pilot aims to facilitate and speed up the coordinated assessment of selected clinical trial applications by strengthening cooperation between national competent authorities and ethics committees. While FAST-EU does not alter the legal requirements set out under the EU Clinical Trials Regulation No 536/2014, it seeks to optimize their practical implementation through earlier dialogue, tighter procedural coordination, and reduced assessment timelines.

The European fast-track approach is primarily intended for clinical trials of high strategic or public health interest, such as studies involving innovative therapies, significant unmet medical needs, or complex multinational designs. Importantly, acceleration remains conditional on the submission of complete and high-quality dossiers, and does not affect the substantive standards applicable to scientific evaluation, ethical review, or the protection of trial participants.

From a legal and strategic perspective, these European initiatives reflect a clear policy objective: reducing regulatory fragmentation and increasing predictability across Member States. For sponsors, particularly those planning multinational trials, faster and more coordinated assessments may result in earlier trial initiation and greater legal certainty within the EU.

In parallel with this European-level initiative, several Member States have introduced or announced national fast-track procedures applicable to mono-national clinical trials. Implemented within the EU regulatory framework, these national schemes aim to further enhance domestic attractiveness by shortening authorization timelines at national level. Taken together, the European and national fast-track initiatives illustrate a converging trend within the Union towards a more competitive regulatory environment for clinical trials.

France

In November 2025, the French National Agency for Medicines and Health Products Safety (ANSM) announced the launch, from the first quarter of 2026, of a national accelerated authorization pathway ("fast track") for certain clinical trials conducted exclusively in France. This initiative, part of the France 2030 plan, aims to strengthen France's attractiveness in clinical research by significantly reducing regulatory timelines.

The fast-track procedure is strictly limited to mono-national clinical trials and applies only to studies meeting specific eligibility criteria. These include early-phase trials (Phase I or integrated Phase I/II), trials addressing serious, rare, or disabling diseases with no appropriate available treatment; first-in-class trials exploring entirely new mechanisms of action; and, trials allowing the inclusion of adolescents in protocols initially designed for adults. Eligibility is assessed and confirmed by the ANSM before submission of the application via the European Clinical Trial Information System (CTIS).

The key benefit of the fast track lies in shortened assessment timelines. Where no questions are raised during the evaluation, authorization may be granted within 14 days, compared with the standard 31-day period. If questions are raised, the maximum timeline is reduced to 49 days, instead of the usual 106 days. The scheme will initially be rolled out as a pilot phase, the operational details of which have yet to be communicated.

Importantly, this acceleration does not alter the substantive regulatory framework. Authorization of a clinical trial in France remains subject to a favorable scientific and regulatory assessment by the ANSM, as well as a positive opinion from the competent ethics committee (Comité de protection des personnes (CPP)), which assesses ethical considerations and participant protections.

From a strategic perspective, the fast-track pathway is intended to provide patients with quicker access to innovative therapies and to offer sponsors – both industrial and academic – a competitive advantage when choosing France as a location for clinical research. The ANSM has emphasized that despite accelerated timelines, scientific rigor and participant safety standards will be fully maintained.

To benefit from the fast track, sponsors must submit a complete and compliant dossier via CTIS, strictly meet the eligibility criteria, and respond promptly to any authority requests to avoid delays.

However, the scope of the acceleration is limited to the ANSM's authorization process. Sponsors must continue to anticipate timelines imposed (i) by the time needed for negotiating the clinical trial budget with the coordinating health care establishment, as well as (ii) by other authorities, such as the CNIL for health data processing or the Ministry of Higher Education and Research for biological sample import or export. While this reform represents a major step forward, further simplification across the broader regulatory landscape would be needed to fully optimize clinical trial timelines in France.

Germany

In 2023, the former German government recognized the necessity for Germany to gain attractiveness for pharmaceutical research in its strategy paper "Improving the framework conditions for the pharmaceutical sector in Germany," which identified regulatory simplification and market acceleration as the cornerstone of sector growth. The next year, the Medical Research Act was enacted, implementing the following actions (among others) to further that goal:

• Shortened approval timeline for mono-national clinical trials: for mono-national clinical trials without the involvement of any other EU country, the authorization timeline is shortened to 26 days from the validation date.
• Adaptions concerning ethics committees: a specialized central ethics committee was established for clinical trials with the attention of the Emergency Task Force of the EMA, complex clinical trials, Phase I clinical trials, ATMP trials, as well as for performance studies regarding companion diagnostics intended for the safe and effective use of a medicinal product. For all other clinical trials, responsibility remains with the registered ethics committees according to the respective schedule. In addition, the Working Group of the Ethics Committee in Germany was given the competence to issue guidelines for the assessment of clinical trial applications to facilitate a harmonized authorization process and requirements for all ethics committees in Germany.
• Simplified approach regarding Radiation Protection law: if a clinical trial requires a permit under German Radiation Protection law, the respective application can now be submitted via the Clinical Trial Information System (CTIS) (the "single gate approach"), and then the ethics committee and the German Office for Radiation Protection (Bundesamt für Strahlenschutz (BfS)) assess the application in parallel. If, under Radiation Protection law, the clinical trial must only be notified, there is no assessment by the BfS, only by the ethics committee – in order to avoid double assessments.
• Codification of standard contractual clauses (SCCs): by stipulating certain contractual clauses for publication, intellectual property, liability, and data protection, contract negotiations between clinical trial sites in Germany and sponsors – which are often lengthy – can be shortened. SCCs are generally binding, but contract parties can explicitly deviate from the SCCs, which may be especially beneficial to sponsors.
• Direct dispensing of study medicinal products and auxiliary medicinal products to trial participants: study medicinal products and auxiliary medicinal products can be dispensed directly to trial participants under certain conditions; for example, if there are no means by which a sponsor can identify the trial participant.
• Labeling of study medicinal products and auxiliary medicinal products: study medicinal products as well as auxiliary medicinal products may be labeled in English only, if they are directly applied by the investigator or the study team.

United Kingdom

The UK has introduced a series of ambitious reforms to further enhance its appeal as a destination for clinical research, including a single application process for combined regulatory and ethics review.

• Combined review: The UK's Combined Review Service allows the Medicines and Healthcare products Regulatory Agency (MHRA) and UK Research Ethics Service to conduct parallel assessments of clinical trial applications, reducing administrative burden and expediting the authorization process. The UK also participates in international initiatives such as the Access Consortium and Project Orbis, supporting harmonized or simultaneous review of clinical trial applications across multiple jurisdictions.
• Fast-track review: Launched by the Health Research Authority (HRA) in 2023, the fast-track Research Ethics Committee (REC) review offers a rapid ethics review service for most multi-country trials involving the UK and phase I or phase I/II trials in healthy volunteers or patients. The target is a final ethics opinion within 15 calendar days of validation: a substantial reduction from the standard 60-day timeline. For urgent public health research, such as COVID-19 or mpox studies, review can take as few as 48 hours.
• Low-risk notification scheme: Introduced as a pilot in 2024 set to become standard in April 2026, the MHRA notification scheme provides a streamlined regulatory pathway for certain low-risk trials. The scheme can be used alongside the fast-track REC pilot, so sponsors of eligible low-risk trials can benefit from both rapid regulatory notification and accelerated ethics review, significantly reducing the time from submission to trial initiation.
• Further measures: As part of the reforms to UK clinical trial regulation taking effect in 2026, both the MHRA and RECs will operate under a new statutory maximum 30-day review period for most clinical trial applications. This is the first time that statutory timelines have been introduced for clinical trial reviews in the UK, providing sponsors with greater predictability and ensuring that both regulatory and ethical assessments are completed within a streamlined window.

Collectively, these fast-track and modernization initiatives offer sponsors greater speed, flexibility, and legal certainty when running trials in the UK, and they complement broader European and global efforts to accelerate clinical research.

Spain

In May 2024, the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) launched a fast-track procedure with the aim of making Spain a more attractive environment for innovative drug research by allowing shorter authorization timelines for certain clinical trials. The fast-track procedure applies to Phase I clinical trials with biological or biotechnological medicinal products intended for oncology or rare diseases, as well as to bioequivalence trials. In general terms, the main elements of the fast-track procedure can be summarized as follows:

• Sponsors must submit the application through CTIS exclusively for Spain, select an Ethics Committee that has joined the fast-track procedure, and contact the AEMPS prior to submitting the application by writing to [email protected] – indicating the planned submission date, evaluating Ethics Committee, and characteristics of the trial (e.g., title, indication, investigational medicinal product, population, and other relevant information).
• The AEMPS will confirm its availability to carry out an accelerated assessment, taking into account the dates proposed by the sponsor and the characteristics of the trial and the investigational medicinal product. If several applications coincide within the same time period, the AEMPS will determine the most appropriate timelines for each application and communicate its decision to the sponsor.
• Once the AEMPS has issued its fast-track acceptability approval, an application will be validated on an expedited basis and assessed within 26 days from validation, with authorization granted within that timeframe, provided that no requests for clarification are required. If during the course of the assessment the complexity identified makes the shortened timelines unfeasible, the AEMPS will inform the sponsor of the newly adjusted timelines.
• When submitting an application, it must be stated in the cover letter that participation in the fast-track procedure has been accepted by the AEMPS. Given that accelerated assessment involves a multidisciplinary team with dedicated resources, if the sponsor does not meet the planned submission date, a new request for accelerated assessment will be required in order to optimize the resources allocated.

It is already known that the AEMPS has authorized a first clinical trial under the new fast-track procedure, with a regulatory process completed in merely 60 days, compared to the more than 100 days that are usually required. This is a Phase I/II study evaluating an investigational oncology medicinal product in patients with advanced solid tumors. This milestone comes one year after the first fast-track pilot trial authorized by the AEMPS, which involved a Phase I vaccine trial. This new step confirms the consolidation of a new regulatory framework aimed at streamlining the development of innovative therapies in early phases.

Belgium

In October 2025, the Belgian Federal Agency for Medicines and Health Products (FAMHP) announced the introduction of accelerated evaluation timelines for clinical trial applications involving medicinal products for human use. The framework applies as of 1 January 2026, and has been effective since 7 January 2026, following the winter suspension period.

Accelerated timelines for mono-national clinical trials

Since January 2026, mono-national clinical trials conducted exclusively in Belgium benefit from significantly shortened evaluation timelines depending on the clinical phase:

• Phase I, Phase I/II and Phase II trials: Evaluation within 20 days following submission, or up to 59 days where additional information is requested by the authority.
• Phase II/III, Phase III, Phase III/IV and Phase IV trials: Evaluation within 35 days, or up to 79 days if requests for further information are issued.

For ATMPs and certain biotechnological medicinal products, a possible extension of 10 days may apply to the evaluation timelines.

The FAMHP has confirmed that these accelerated timelines apply to both Part I and Part II of the CTIS submission dossier. Overall, the new deadlines represent a reduction of approximately 50% compared with previous standard timelines.

Participation in the European FAST-EU initiative for multinational clinical trials

While a national Belgian pilot for accelerated evaluation of multinational clinical trials had initially been announced by the FAMHP, the FAMHP has decided not to pursue this national pilot. Instead, Belgium will participate in the European FAST-EU pilot initiative for accelerated and coordinated assessment of selected multinational clinical trials. Since the end of January 2026, the FAMHP – together with the Clinical Trial College ("CT-College") and several Belgian ethics committees – are actively testing the FAST-EU approach for a selection of multinational clinical trials. Belgium may apply this accelerated procedure either as a Reporting EU Member State or as an EU Concerned Member State.

Italy

In Italy, although there are currently no national fast-track procedures in place, several measures have been introduced to enhance the attractiveness of the Italian market and the regulatory environment for conducting clinical trials.

Notably, on 2 August 2024, the Italian Medicines Agency (AIFA) issued the "Guideline on Simplification and Decentralized Clinical Trials." These guidelines include the following key provisions:

• Investigational medicinal products (IMPs), which are by law shipped by the sponsor to the hospital pharmacy of the trial site, may be delivered directly to participants' homes, depending on the type of medicinal product and if transport and storage conditions are suitable.
• For clinical trials that address public health conditions (such as highly prevalent chronic diseases, including diabetes, dementia, and hypertension) and that aim to improve disease management at a population level, clinical centers outside hospital settings may be used. These may include Nursing Homes/Long-Term Care Facilities (RSA) or similar facilities, as well as public institutions.
• Third-party service providers may be engaged to perform certain trial activities, such as delivery of the IMP, conducting protocol-required procedures at a participant's home, or appointing qualified personnel. This approach is intended to prevent the exclusion of segments of the population from participation in clinical trials due to limited resources at trial sites.

Furthermore, to streamline and improve the efficiency of the assessment of clinical studies and to ensure uniform standards, a reorganization of Ethics Committees was implemented in 2023. The number of Territorial Ethics Committees was reduced from 90 to 40, and three National Ethics Committees with exclusive competence were established: in the pediatric field, for ATMPs, and for studies sponsored by Public Research Bodies (EPRs).

Finally, Italy will participate in the European FAST-EU pilot initiative for the accelerated and coordinated assessment of selected multinational clinical trials, as recently confirmed by AIFA.

The Netherlands

On 6 December 2024, the Dutch (previous) government acknowledged the importance of the Netherlands remaining an attractive location for medical scientific research, citing its significance and positive contribution to society. It urged the Netherlands to remain an attractive country for research into new therapies, and that assessment procedures not become more rigid compared to neighboring countries. A fast and efficient assessment procedure is crucial in situations of health crises, it stated. Currently, however, there are no specific fast-track pathways for medical scientific research under Dutch law.

In the Netherlands, the Medical Research Involving Human Subjects Act (WMO) regulates medical scientific research, meaning medical scientific research that involves subjecting individuals to procedures or imposing a certain course of conduct on them. The WMO does not address timelines for the assessment by ethics committees of medical scientific research submissions. For medical scientific research falling within the scope of the CTR, MDR, or IVDR, the timelines are followed in the respective regulations.

Insofar as medical scientific research does not fall within the scope of the CTR, MDR, or IVDR, the timelines for administrative decisions in general are leading, as laid down in the General Administrative Law Act (Awb). Under the Awb, administrative decisions must be taken within a "reasonable period" after receiving the request. On its website, the Dutch Central Committee on Research Involving Human Subjects (CCMO) – which assesses CTR, MDR, and IVDR submissions – takes the view that a "reasonable period" is eight weeks at maximum. Nevertheless, this period may be extended with the "shortest possible period," with an additional eight weeks at maximum, in the view of the CCMO.

During an evaluation of the WMO in 2024, it appeared from a questionnaire survey that about one-third of the applicants were critical of the speed at which protocols were assessed by the CCMO and Dutch medical research ethics committees. Several practical and legal recommendations have been made in the report of the evaluation, aiming to achieve a future-proof assessment procedure. In December 2024, the (previous) government also announced its intention to amend the WMO, but it is uncertain whether such amendment would include the adoption of a fast-track pathway.

Given the intention to amend the WMO and the ongoing developments in France, Germany, Spain, and Belgium, it is possible for fast-track pathways to be introduced in the Netherlands. The current government has taken office on 23 February 2026, and it remains unclear whether it has any plans to introduce fast-track pathways in the Netherlands.