UK Profile Updated in ClinRegs

December 8, 2020
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The United Kingdom profile in ClinRegs has been updated with the following information:

  • The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (No. 744), which allows new guidance documents to come into force post-Brexit on January 1, 2021 (See Scope of Assessment)
  • Registering to Make Submissions to the MHRA from 1 January 2021, which applies to all clinical trial submissions (initial applications, substantial amendments, end-of-trial notifications, and developmental safety update reports (DSURs) (See Scope of Assessment, Submission Process, Trial Authorization, Manufacturing & Import)
  • Letter to Medicines and Medical Product Suppliers: 17 November 2020, which indicates that the UK will recognize certain European Union (EU) regulatory processes for a limited time starting in January 2021 (See Scope of Assessment, Manufacturing & Import, Product Management)
  • List of Approved Countries for Clinical Trials and Investigational Medicinal Products from 1 January 2021, which specifies where a clinical trial sponsor may be established starting in January 2021 (See Submission Process, Trial Initiation, Trial Authorization)
  • Guidance on Substantial Amendments to a Clinical Trial from 1 January 2021, which details when a substantial amendment for a change in sponsor must be submitted starting in January 2021 (See Submission Process, Definition of Sponsor)
  • Importing Investigational Medicinal Products into Great Britain from Approved Countries from 1 January 2021, which provides quality assurance guidance on investigational products (IPs) imported from countries and what constitutes a substantial amendment related to IPs starting in January 2021 (See Manufacturing & Import)
  • Update to remittance of payment to MHRA (See Regulatory Fees)
  • A new fast-track research ethics review pilot (See Scope of Review)
  • Update to the single submission pilot, which is accepting new participants again in January 2021 (See Submission Process)

 Additional Updates:

  • ClinRegs will monitor Brexit developments and update the profile after the transition period ends and Brexit comes into full force on January 1, 2021. Until then, the regulated community should continue to follow the current regulations and guidance, which includes EU processes and tools.
  • Some Health Research Authority (HRA) links in the UK profile may not work at this time. The ClinRegs team is closely monitoring the HRA website and will update the UK profile as necessary.
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