FAQs |
How are clinical trial participants to be protected under the Regulations?
What are the transitional arrangements for a trial that began before the Regulations were introduced?
MHRA agreed transitional arrangements for clinical trial authorisations. They also agreed transitional arrangements for manufacturers to apply for licences to manufacture IMPs. Nearly all currently authorised clinical trials were converted to “Clinical Trial Authorisations” without any further application. For a few trials, more information may be required if they are with unlicensed products on which there is insufficient data to meet the new requirements. MHRA recruited additional staff to handle the increased number of applications.