The Future of Clinical Trials in the European Union, and the ‘ACT EU’ Initiative

Jan 28, 2022
2 min read

The European Commission (EC), Heads of Medicines Agencies (HMA), and European Medicines Agency (EMA) recently published their initiative, titled: ‘Accelerating Clinical Trials in the EU’ (ACT EU).

The initiative is designed to support, streamline, innovate, and transform the way European clinical trials are conducted. In a recent media release, the EMA stressed:

“The aim is to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.”

Significantly, the ACT EU initiative details six primary objectives, summarised as follows:

1. Optimising the EU clinical trial environment, while maintaining protections, transparency, and data robustness.

2. Strengthening clinical trials for unmet medical needs, rare diseases, and therapeutics for health crises and pandemics, whilst supporting health technology assessment bodies (HTAs), and sponsors.

3. Providing coordinated scientific advice to complement trial authorisation and supporting marketing authorisation and access.

4. Proactively engaging stakeholders to deliver patient-focused product development and delivery.

5. Clarifying and unifying the European position on clinical trials internationally.

6. Building capacity in development and regulatory science by fostering collaboration with academia.

Further, the EC, HMA and EMA have detailed ten priority actions for the 2022-23 period. The priority actions target areas including, but not limited to, governance; clinical trials regulation (CTR); stakeholder engagement; modernisation of good clinical practice; communication; methodology guidance development; pre- and post-market safety analysis; and training.

It is crucial to stay informed of changes in approaches to product research and development, and regulatory environments. Importantly, Komply can help in designing and managing your clinical studies.

Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.

Comments