The New EU Clinical Trials Regulation (EU) No. 536/2014

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With the new regulation coming into force from the end of January 2022, there will be implications on the authorization of clinical trials and how they are managed throughout the European Union (EU).

The way in which clinical trials are conducted in the EU will undergo a major change on January 31, 2022, with a three year transition period allowance. In order to harmonize the assessment and supervision processes for clinical trials throughout the EU, the new Clinical Trials Regulation (EU) No 536/2014 will come into force with the existing EU Clinical Trials Directive (EC) No. 2001/20/EC repealed.

The regulation is applicable to all Investigational Medicinal Products (IMP) for human use.

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Why This Change to a New Regulation?

In order to harmonize the way in which clinical trials are managed across the EU, and to make the EU a more attractive location for clinical trials, it was agreed that a new regulation was needed to provide clear requirements, to help reduce gold plating amongst Member States, and to ensure the highest standards of safety and transparency.

The new regulation will be binding in its entirety with no derogation permitted by individual countries. It also brings about simplicity and harmony, with the aim to foster innovation and research, while avoiding unnecessary duplication of clinical trials or repetition of unsuccessful trials.

The key benefits of the regulation include:

  • Harmonized electronic submission and assessment process for clinical trials conducted in multiple Member States
  • Improved collaboration, information-sharing and decision-making between and within Member States
  • Greater transparency of information on clinical trials
  • Highest standards of safety for participants

How Will it Work?

A single electronic application for trial authorization will be made via the new Clinical Trials Information System (CTIS). The CTIS will contain the centralized EU portal and database for clinical trials. The European Medicines Agency (EMA) will set up and will maintain the CTIS in collaboration with the Member States and the European Commission. The CTIS complements the General Data Protection Regulation (GDPR), strengthening the security of personal data. It provides the legal basis for storing and processing personal data and is in addition to GDPR consent.

The Sponsor proposes a “Reporting Member State”, with clear timelines for evaluation and notification. The Member State then determines an appropriate body or bodies to be involved in the assessment, providing a single, combined regulatory and ethics authorization for the trial.

The application is made in two parts:

  • Part 1 assessment, containing the common scientific documents e.g. application form protocol, investigator brochure etc.
  • Part 2 assessment is the consideration of specific national or local factors e.g. liability, data protection, investigator sites etc.

The portal will also be used to report serious breaches, urgent safety measures (USMs), annual safety reports, the two required summary of results (one which should be understood by a lay person and the other a scientific report) and a full Clinical Studies Report (CSR).

Impact on Investigator Sites

Some new requirements will have a significant impact on Investigator sites and trial conduct, including:

  • Learning and applying the new consent requirements
  • Complying with the 24 hour reporting of serious adverse events
  • Complying with reporting of USMs: within 7 days from when the USMs happened
  • Working with the Sponsor regarding serious breach reporting
  • New document archiving requirements
  • Documented or certified training

The Sponsor and Investigator shall keep a clinical trial master file, which contains essential documents to ensure safety and quality measures remain in place throughout. This file must always be readily available upon request and should be retained for at least 25 years after the end of the clinical trial. Medical files should be archived in accordance with national law.

How Can SGS Help?

This new regulation will pose challenges to Sponsors of clinical trials, including selecting the best submission strategy during the transition period and responding to queries in the required time. New Standard Operation Procedures (SOPs) will be necessary for a range of areas of your business such as query response, serious breaches and ethics committee/health authorities submissions, and we will be there to support you with these.

As a leading European early phase contract research organization with over 40 years’ experience in clinical research, we are uniquely placed to help you design, develop and implement clinical trial solutions for your specific needs. With this change, we have performed a gap analysis to align our procedures with the new Clinical Trial Regulation and can support you in order to define which is the best submission approach during the transition period.

Do you need help with optimizing your clinical timelines? SGS can help bring your product to the market quickly and safely. We can support you with fast and smooth testing and development processes, enabling you to make safe ‘go / no go’ decisions about your product that are based on the most reliable data.

Transition Timeframe

Transition Timeframe of the New Clinical Trials Regulation

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