Transition to the new regulations

Transitional Provisions

The updated UK Clinical Trials Regulation includes transitional provisions that determine which archiving and retention requirements apply, based on the date a clinical trial application was submitted. Understanding this distinction is essential to ensure continued compliance during and after the regulatory changeover.

Trials Submitted Before 28 April 2026 (“Old Rules” Clinical Trials)

Clinical trials where the application was submitted before 28 April 2026 must continue to comply with the previous archiving requirements set out in regulation 31A(7) and 31A(7A).

Under these provisions:

  • The Trial Master File (TMF) must be retained for at least five years after the conclusion of the trial. However it is worth noting that it is recommended to retain the TMF for 25 years in line with EU CTR.
  • The TMF must remain complete, legible, and readily available to the licensing authority throughout the retention period.
  • Where trial data is used to support a UK marketing authorisation, essential records must be retained for two years after the authorisation is granted.
  • Participant medical records must comply with new regulation 31A(8) and be retained for a minimum of 25 years after trial conclusion.

Trials Submitted On or After 28 April 2026 (“New Rules” Clinical Trials)

Clinical trials where the application is submitted on or after 28 April 2026 must comply fully with the updated archiving and retention requirements set out in regulation 31A(7), 31A(7A), and 31A(8).

These requirements include:

  • A minimum retention period of 25 years for the TMF and all associated essential records.
  • Ongoing obligations to ensure records remain complete, legible, readily retrievable, and securely maintained throughout the retention period.

Requirements Applicable to All Clinical Trials

Regardless of the application submission date:

  • Documentation relating to an authorised medicinal product must be retained for as long as the product remains authorised.
  • The final clinical study report must be retained for five years after the product is no longer authorised

Arkivum Website | Contact Us | Privacy Policy

Arkivum Limited is registered in England and Wales, company number 7530353 Registered Office: Arkivum, 85 Great Portland Street, First Floor, London W1W 7LT. United Kingdom.