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The European Medicines Agency (EMA) proposes European Union (EU) clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

The European Commission (EC), European Medicines Agency (EMA) and EU regulators from The Heads of Medicines Agencies have set out proposals in a new initiative: Accelerating Clinical Trials in the EU (ACT EU).

The initiative aims to transform the design of clinical trials and increase efficiency, by extension positioning the EU Member States as a collective international clinical research “focal point”.

The ACT EU document details objectives, priorities and governance strategies, involving measures to allow for a greater implementation of clinical trial designs. The aim of implementing the initiative is for ACT EU to contribute to providing the Network strategy to 2025, alongside the Commission Pharmaceutical Strategy and the European Medicines Regulatory Network (EMRN) strategy in its goals to “foster innovation in clinical trials”.

Part of the EMA’s plan is to collaborate with other EU regulators to produce guidance on innovative trial designs, involving AI and machine ingenuity.

The paper recognises the impact of the COVID-19 pandemic as a major global event that has further highlighted the “disharmony of regulatory requirements between Member States” and the consequential complications surrounding “the submission of multi-state trial applications”, while many are still processed at a national level.

A main objective detailed in the paper is to better coordinate scientific advice “as a complement to trial authorisation and to support marketing authorisation and access throughout the medicine life cycle”, with efforts outlined to increase efficiency through ensuring “a clear and unified European position on clinical trials in strategic matters at the international level”.

The paper acknowledges that the current environment for clinical trials is “challenging”, given the friction created by varying regulatory requirements between the Member States. The paper suggests this often results in slow and costly trial authorisations and can lead to a subsequent negative impact on trial research within the EU, particularly during a global health crisis.

The EMA states:

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.

The ACT EU paper proposes an approach for resourcing, stating the opportunities for the Network to utilise expertise and available resources in order to further its objectives and those involving public health and patients. To achieve this, it suggests that a “collaborative and integrative approach offers a real opportunity to transform a moderate resource input from the Network into a very large research impact in the EU” by delivering a four-point framework of “Do, Require, Influence, Support”.

By adopting this strategy, patient-centricity is given a better platform and the discussion around public health and addressing unmet clinical needs is prioritised.

Another avenue the paper suggests as a means of utilising available resources is to prioritise the delivery of “clinical trials training curriculum”, specifically including modules on regulatory science and drug development, working in tandem with universities in order to create “an educational ecosystem”.

The initiative will further develop the EU’s 2014 Clinical Trials Regulation (CTR) in line with the launch of the Clinical Trials Information System (CTIS) – following a delayed launch in 2018 – which will begin at the end of January 2022.


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