The global clinical research landscape is evolving rapidly, and Europe has no intention of standing still. While the United States and Asian countries continue to attract an increasing share of multinational studies, European institutions have launched a structured and ambitious response: a two-year plan designed to transform Europe into a more efficient, harmonized, and attractive environment for sponsors worldwide.
The CTCG 2026–2027 Plan: Objectives and Priorities
The Clinical Trials Coordination Group (CTCG), the working group of European national regulatory authorities coordinated by the HMA (Heads of Medicines Agencies), has published its workplan for the 2026–2027 period. The document sets the course for strengthening clinical trial governance across the European Union, with particular focus on reducing implementation inconsistencies among Member States.
The priorities outlined in the plan are concrete and measurable. First, the goal is to strengthen collaboration among national competent authorities by reducing the procedural asymmetries that still make the authorization process unpredictable for both industrial and academic sponsors. Secondly, the plan calls for the adoption of innovative methodologies such as adaptive design studies (flexible studies that allow protocol modifications during the trial based on emerging data) as well as the integration of advanced digital technologies, including artificial intelligence, into the assessment and management of clinical trials.
A particularly significant objective concerns study start-up timelines: by 2027, at least two-thirds of clinical trials should begin patient recruitment within 200 days from application submission, a target that requires unprecedented synergy among regulatory bodies, ethics committees, and sponsors.
FAST-EU: The Fast Track for Innovative Clinical Trials
One of the most significant developments of recent months is the launch of the FAST-EU pilot project (Facilitating and Accelerating Strategic Trials in the EU), operational since January 30, 2026. The initiative is coordinated by the CTCG, HMA, and MedEthicsEU, and aims to drastically reduce authorization timelines for multinational clinical trials with high scientific and therapeutic value.
FAST-EU’s defining feature is the guarantee of an end-to-end assessment completed within a maximum of ten weeks from submission through CTIS (Clinical Trials Information System, the centralized European portal managed by the EMA for the submission and management of clinical trial applications across all EU and EEA Member States, operational since 2022 under EU Regulation 536/2014). This represents an ambitious target compared to current average timelines. Eligibility criteria for the accelerated pathway take into account the medical relevance of the study, the geographic balance among participating countries, and the potential impact for patients. As reported by AGES, the Austrian medicines agency actively involved in the project launch, FAST-EU represents a major step forward for the competitiveness of European clinical research.
FAST-EU is also designed as a collective learning mechanism in preparation for the implementation of the future European Biotech Act, the legislative proposal presented by the European Commission in December 2025 that could significantly reshape the biomedical research ecosystem across Europe.
ACT EU and the CTIS System: The Regulatory Framework
The CTCG’s two-year strategy is part of a broader regulatory transformation already underway for several years. EU Regulation 536/2014 on clinical trials and the CTIS system (Clinical Trials Information System) have already transformed the way studies are authorized and managed in Europe by creating a single portal for the submission and management of trial applications across all Member States.
Completing the framework is the ACT EU program (Accelerating Clinical Trials in the EU), launched in 2022 by the European Commission, the EMA, and national authorities. ACT EU provides the strategic framework for all modernization initiatives: from improving study design and enhancing access to trial data, to strengthening patient involvement and developing more efficient experimental methodologies. The ACT EU 2025–2026 workplan also includes pilot programs dedicated to consolidated pre-submission scientific advice, already available to applicants in 2026.
Why Europe Must Regain Competitiveness
The competitive environment behind this strategy is highly challenging. In recent years, Europe’s share of multinational clinical trials has progressively declined in favour of markets such as the United States, China, Japan, and South Korea, which have succeeded in offering more streamlined regulatory environments and faster study start-up timelines.
The implications are not merely scientific: clinical trials generate investment, specialized employment, technological know-how and, above all, provide patients with early access to innovative therapies. A Europe that is less attractive for clinical research means fewer therapeutic opportunities for its citizens.
The 2026–2027 relaunch strategy seeks to reverse this trend by focusing on harmonization, speed, and methodological innovation as key drivers. The objective is not only to increase the number of studies authorized each year, but to build a clinical research ecosystem that is structurally competitive over the long term.
Clinical Trial Translation: Why a Specialized Partner Makes the Difference
In this increasingly international clinical research environment, one of the most strategic, and often underestimated, aspects concerns clinical trial translation: a complex, high-impact activity that directly affects the quality of regulatory documentation and a sponsor’s ability to operate effectively across multiple countries simultaneously.
Translating a clinical trial means managing extensive and highly technical documentation: study protocols, authorization dossiers, patient information sheets, investigator brochures, informed consent forms, safety reports, and plain-language summaries. All these documents must be translated into multiple languages with absolute precision, while complying both with international scientific terminology (including EMA and ICH terminology) and with local regulatory requirements imposed by national competent authorities. Clinical trial translation is therefore far from a standard linguistic service: it requires native-speaking translators with scientific expertise and full familiarity with the European regulatory framework.
A terminology error in the translation of a clinical trial, whether in a patient leaflet, informed consent form, or regulatory document, can lead to authorization delays, requests for clarification from regulatory agencies, or, in the most serious cases, compromise the validity of the study itself. In a context where FAST-EU aims to complete the authorization process within ten weeks through CTIS, there is no room for linguistic inaccuracies: translation quality is an integral part of the regulatory pathway.
This is where the value of a specialized partner becomes essential, a provider experienced in medical-scientific translations and medical device documentation, capable of delivering services tailored to the specific needs of the sector: native-speaking translators with scientific backgrounds, familiarity with EMA and ICH terminology, and in-depth knowledge of EU Regulation 536/2014 and CTIS requirements.
Whether supporting a sponsor in preparing a multinational authorization application, localizing patient-facing documentation into dozens of European languages, or ensuring terminology consistency throughout the duration of a clinical trial, relying on a specialized partner is a strategic decision that Life Sciences companies cannot afford to overlook when precision is non-negotiable.
A Turning Point for European Clinical Research
The CTCG two-year strategy, the FAST-EU project, the ACT EU program, and the CTIS system together outline a regulatory ecosystem undergoing profound transformation. Europe now has both the political will and the technical tools to regain a leading role in global clinical research. The challenge is now to translate these tools into concrete results: for pharmaceutical and biotech companies, for academic research centres, and above all for patients awaiting access to innovative therapies.
For Life Sciences companies operating in this environment, having specialized partners at their side, both from a regulatory and a linguistic perspective, is no longer an option, but a strategic necessity.
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