Mexico and Finland Cut Clinical Trial Approvals to 30 Days as EU Streamlines Rules

Clinical trial approvals are being accelerated on both sides of the Atlantic, with Mexico's Federal Commission for Protection against Health Risks (COFEPRIS) cutting authorization timelines from 120 to 30 days and Finland introducing a 30-day review pathway, while the European Union moves to simplify multinational trial rules under the proposed European Biotech Act.

In the EU, the proposed European Biotech Act aims to strengthen Europe's clinical research by increasing trials and accelerating development of innovative medicines. Approval timelines for initial applications would be cut from 75 to 47 days, or from 105 to 76 days for multinational trials. Time to approve substantial modifications would be reduced from 64 to 33 days when no additional information is required, and to 75 and 47 days when additional information is needed. The Act also introduces harmonized procedures, including a single core dossier for multiple trials with the same investigational medicinal product, simplified pathways for minimum-risk trials, a harmonized legal basis for data processing, and a single authorization process for combined studies. EU health ministers are scheduled to discuss the proposed Act at a Council meeting on 16 June, where the Council is expected to adopt a general approach on a directive regarding the placing on the market of genetically modified micro-organisms.

EU-wide performance data show 19 additional multinational clinical trials have been authorized compared with the first three months of last year, and currently 40.5% of trials recruit participants within 200 days of application submission. The EU target is to increase this to 66% by 2030. The European Commission also launched an effort to approve 100 more studies per year by 2030.

Finland has introduced an accelerated review pathway under which all national clinical trial applications are to be assessed within 30 days of submission, provided that no additional information or corrections are needed during evaluation. In parallel, Finland will establish FinTrials, a national operating model for clinical trials, to improve coordination of clinical trials of medicines and clinical investigations of medical devices. The coordination unit will operate in connection with the Finnish Biobank Cooperative. FinTrials will start operating in stages in 2026–2027, with a call for government grant applications opening in June 2026 for a total of EUR 2 million. Clinical trials and investigations bring research investments worth more than EUR 250 million to Finland every year.

Mexico's COFEPRIS cut clinical trial approval times from 120 to 30 days, announced at the Scientific Conference 2026. The Ministry of Health outlined three pillars: regulatory improvement, attracting clinical research investment, and pharmaceutical sovereignty. In May 2025, COFEPRIS announced a 65% reduction in response times for clinical protocols — from 115 to 40 days — with a goal of reaching a two-week turnaround. COFEPRIS also implemented a Regulatory Reliance agreement that recognizes evaluations by the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, and Health Canada to expedite approvals. Mexico seeks to increase its participation in international multicenter studies, particularly in oncology, endocrinology, and infectious diseases.

Belgium is also seeking to boost its clinical-trial competitiveness through ethics reforms. The federal government has placed reforms to ethics committees on the legislative agenda, acknowledging that Belgium and the wider European market are losing ground in clinical research, particularly in advanced therapies. Belgium's ethics review is conducted by 15 accredited Medical Research Ethics Committees, overseen by the College for Clinical Trials. In its 2025 annual report, the College states that harmonisation between committees remains a challenge. An empirical analysis of 6,740 requests for information issued between 2017 and 2024 found an increasing focus on regulatory and procedural aspects. The College identified a need for professionalisation and specialisation of ethics committees, and suggested exploring a more concentrated model with fewer committees.

To support multinational applications, a new harmonised EU template (Version 2.0) for participant recruitment and informed consent is now available for all clinical trials conducted in the EU/EEA. Developed by the MedEthicsEU group and endorsed by the Clinical Trials Coordination and Advisory Group, the template covers six key areas, including recruitment procedures, informed consent processes, inclusion of incapacitated adults and minors, and enrolment in emergency situations. It applies to all new Part II submissions from 1 September 2026, after which its use becomes mandatory.