Clinical Trials Highlights

This newsletter provides the latest news on clinical trials from the European Medicines Regulatory Network (EMRN), including news on the joint Accelerating Clinical Trials in the EU (ACT EU) initiative and on the Clinical Trials Information System (CTIS). 

We are now in the final year of transition from the Clinical Trials Directive to the Clinical Trials Regulation (CTR). The application of the CTR strengthens Europe as an attractive location for clinical research by streamlining the processes for application, supervision of clinical trials and the publication of clinical trial data in the Clinical Trials Information System (CTIS).  

All ongoing clinical trials in the EU must be transitioned to CTIS by 30 January 2025. Sponsors with clinical trials expected to continue beyond that date must consider the time required for Member States to complete the authorisation procedure, which can take up to three months.

To help streamline the process, Member States will implement, where possible, an expedited procedure for transitioning trials to the CTR, as described in the CTCG Best practice guide.

There is also guidance and additional support materials available to help sponsors make the transition. Sponsors can also attend dedicated training and info events, including the CTIS bitesize talk on 29 February 2024 and a CTIS Info day on 25 March 2024.

- The EMA Clinical Trials Team

EMA has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector. The SME guide contains comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. This update reflects the changes introduced by the CTR and the CTIS.

The Big Data Steering Group (BDSG) has adopted the report on its 2023 activities. Significant progress in the transformation to data-driven regulation continued in 2023, in line with the European medicines agencies network strategy to 2025 and the 4th BDSG workplan 2023-2025. This also includes the AI workplan 2023-2028 for the European medicines regulatory network to guide the use of AI in medicines regulation in Europe to 2028.

The pilot, which will include ten regulatory procedures in total, recently selected its sixth and seventh procedures: two initial marketing authorisation applications in oncology and gastroenterology.

Applicants or marketing authorisation holders who are planning to submit an initial or post-authorisation marketing authorisation application to EMA by the second quarter of 2024 can still express their interest to participate in the proof-of-concept pilot by writing to rawdatapilot@ema.europa.eu before recruitment concludes.

Participation in the pilot offers a unique opportunity to contribute to the pilot’s learnings which will, in turn, help the EMRN make an informed decision on the role of clinical trials raw data in the EU regulatory decision-making process. The interim pilot report, a summary of which is expected to be published in Q2 2024, will include initial insights on the role of analysis of clinical trial ‘raw data’ submitted to EMA in electronic structured format.

Further information is available on EMA’s Big Data webpage.

As part of continuous efforts to further reinforce the security of user accounts, since January 2024 the EMA Account Management platform has introduced Multi Factor Authentication (MFA). Detailed instructions on setting up MFA for EMA systems are available here. 

Users with User Administrators roles in EMA Account Management, e.g. CTIS Member State Administrators or CTIS Sponsor Administrators, receive email notifications if their organisation has been merged with others due to duplicate entries or acquisitions.

Since January 2024, when requesting access to EMA applications on behalf of an organisation, users are able to select a merged organisation. The merged organisations are displayed with a special location indicating the “surviving” organisation. Users can also request to access historical data or data not yet migrated to the “surviving” organisation. A step-by-step guide on how to request access is available here. 

EMA has introduced Bring Your Own Identity (BYOI) authentication capabilities, to improve security and usability of EMA applications. BYOI allows email address authentication for EMA applications, removing the need for users to remember their EMA username and password. Users can opt-in to email authentication in EMA Account Management by following the detailed instructions.