06/15/2026  |  Gareth Macdonald  |  BioXconomy

https://www.bioxconomy.com/clinical-and-research/ema-prepares-for-major-clinical-trial-regulation-changes-under-eu-biotech-act-coming-this-year 

The agency will allocate resources to update systems before new rules take effect, aiming to speed assessments and cut administrative burden for sponsors.

The EU Biotech Act will result in “significant changes” to the Clinical Trial Regulation and Clinical Trials Information System, according to the European Medicines Agency (EMA).

The Amsterdam-based regulator made the comments this week, explaining its management board will allocate resources to prepare for these changes before the Biotech Act comes into full effect.

An EMA spokesperson told BioXconomy, “In December 2025, the European Commission proposed the Biotech Act. This aims to modernize the regulatory framework and, through more agile regulation, strengthen the EU’s competitiveness in research and development. 

“Building on what has already worked well under the Clinical Trials Regulation, the Biotech Act proposes amendments to support high-quality science, reduce administrative burden, and ultimately improve patients’ access to innovative treatments,” she added.

In addition to facilitating faster trial assessments, the Act will modify the CTR to give sponsors and CROs greater flexibility when it comes to adjusting ongoing studies, the spokesperson said. It will also prompt an update of the CTIS, the public database where sponsors log information about drug research.

Related:EMA proposes contract platform to aid sponsors, sites, and CROs

“The implementation of the Biotech Act will be supported by enhanced system functionalities of the Clinical Trials Information System, the central platform that enables sponsors to submit a single clinical trial application to multiple Member States,” she said.

The European Commission proposed the EU Biotech Act in December and called for feedback on the plan. Adoption is not expected to occur before the end of the year.

ACT EU
The spokesperson positioned the Biotech Act alongside other efforts to make the EU more attractive to sponsors, citing measures introduced under the Accelerating Clinical Trials in the EU (ACT EU) initiative—such as the recently launched trial map—as examples.

She told us, “These measures help address practical barriers and support more efficient trial setup and conduct … The ACT EU Multi-Stakeholder Platform brings together patients, healthcare professionals, academic and commercial sponsors, and regulators, ensuring that diverse stakeholder perspectives are systematically reflected in the initiative’s ongoing activities. 

“This approach supports a more efficient and competitive clinical trials landscape and contributes to measurable improvements against the EU’s 2030 targets for more multinational trials and faster recruitment timelines,” she said.