December 2020: UK Regulatory Update

An FAQs document was published by MHRA on 21 December 2020. The guidance document referred to in the FAQs is the guidance document published on September 01, 2020 (LINK).

Section C, questions 3, 4, 5, 7, 8 and 9 deal with disclosure related aspect. Below are the summarized points based on the questions and answers:

  1. For the UK clinical trials (CTs) approved and entered in EudraCT prior to January 01, 2021, the results posting can still be completed in EudraCT. This will meet the UK publication requirement.
  2. For CTs approved after January 01, 2021, results can be posted on a public database, where the study is registered.
  3. Once the results are made public, an email confirmation must be sent to MHRA about the same.
  4. If a clinical trial is not on a public register (e.g. Phase 1 healthy volunteer), summary results should be submitted to the MHRA.
  5. The Health Research Authority (HRA) at [email protected] will need to be contacted, in case deferral is required.
  6. If a Phase 1 healthy volunteer study is approved before December 31, 2020, and entered on the EU Clinical Trials Register (but not visible to the public), then either a copy of the EU Clinical Trials Register upload or a copy of the CSR synopsis has to be submitted to MHRA

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