The Biotech Act aims to make Europe a faster and more attractive place to run clinical trials. This article explains how, if enacted, it would streamline the regulatory landscape by introducing a suite of measures designed to enhance Europe's competitiveness in clinical development, including:

Accelerated approvals

One of the most significant changes for sponsors in the EU would be the acceleration of clinical trial approval timelines. The Act proposes to reduce the maximum authorization period for initial multinational clinical trial authorizations from 106 to 75 days. Timelines for the assessment of substantial modifications will be shortened as well. Importantly, the timelines for clinical trials investigating ATMPs would be the same as for any other products (i.e., the current additional 50-day review period would be removed).

Harmonized assessment and submission documents

Further, assessment procedures would be harmonized and streamlined by a stronger role of the reporting Member States (RMS) leading the scientific, ethical and regulatory assessment. Also, sponsors would be expected to use harmonized template documents to create the submission documents for Part II of the application dossier. To date, submissions for Part II are not harmonized, resulting in administrative burden for both sponsors and Member States.

Introduction of single core dossier

The Act introduces the concept of a single core dossier for an investigational medicinal product (IMP). This provides the opportunity for sponsors to create a single dossier which can be used as a basis for multiple clinical trials testing the same IMP. Subsequent applications for corresponding clinical trials can then refer to this core dossier, resulting in much simpler and more streamlined creation of submission documents for such subsequent applications.

Combination studies for IMPs and IVD/medical devices

Combined studies involving an IMP and medical devices/in vitro diagnostics (IVD) would benefit from a newly introduced unified assessment process. As of today, clinical trials for IMPs used in combination with medical devices (e.g., a companion diagnostic device (CDx)) often face the challenge that no CE-marked devices are available at the time of the clinical trial. The current regulatory framework acknowledges that a combined study of an IMP with a CDx performance study is in principle possible to address this issue. However, it does not provide for a harmonized procedure for such combination studies and thus each Member State concerned applies different standards and procedures when assessing a respective application.

By cutting timelines, reducing fragmentation, and simplifying complex study designs, the EU Biotech Act addresses long-standing pain points.