MHRA regulatory flexibilities resulting from the COVID-19
The Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance for industry on their flexible approaches to regulation during the COVID-19 outbreak.
MHRA are working closely with the Department of Health and Social Care (DHSC) and other healthcare partners and stakeholders to rapidly identify where flexibilities in the regulation of medicines and medical devices may be possible.
These regulatory flexibilities are:
- temporary and will be kept under review, except where regulatory extensions have been stated
- offered to provide flexibility in exceptional circumstances
- effective immediately
The guidance was first published on April 1st, 2020.
Contents:
- Clinical trials
- Marketing authorisations
- Pharmacovigilance
- Inspections and good practice
- Blood components for transfusion
- Medical devices
In the last update of May 7th, MHRA:
- Restructured the page so it is easier for users to read.
- Added dates to show when flexibilities were added.
- Added in new information on clinical investigations for devices, relaxation of risk minimisation measures and flexibility in reporting requirement for ICSRs.
For more details please see the original communication from MHRA.
Contact Meditrial to learn more
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
