Last week’s round -up;
15-19 February 2021

published 22 Feb 2021

MHRA has updated their guidance on managing CTs during this pandemic

The guidance now includes a section on “Management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials”. The Sponsor should conduct a specific risk assessment for concomitant use of a COVID-19 vaccine for each IMP and with specific consideration for the trial population. Some trials may also need to consider risk assessment for non-IMPs and/or combinations.

Details in full can be found here:

CMDh revised MRP/DCP guidance

The CMDh has released the following revised MRP/DCP and national procedure guidance:

• Requirements on Submissions (number and format) for New Marketing Authorisation Applications within MRP, DCP and National Procedures (tracked).

• Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures (tracked).

• CMDh annotated QRD template for MR/DC procedures (tracked).

UK MHRA has updated the fees payable to the MHRA for 2020 to 2021

Update the MHRA fees for marketing authorisations and variations now include the new national procedures following exit from the EU, and the new UK “Orphan Marketing Products” fees, available at the following link:

 UK MHRA has updated some medical device guidance

Guidance on applying human factors to medical devices – The updates are primarily around this guidance applying to Great Britain, changes in references to legislation and the introduction of the new UKCA mark. Assistive technology: definitions, examples and safe use – Updates include a new section on the regulations in Northern Ireland. Medical device safety information produced by the MHRA – The MHRA publishes National Patient Safety Alerts (NatPSA) for medical devices and medicines. When an issue does not meet the criteria for a NatPSA, but still needs to be broadcast, MHRA may issue a different type of communication, such as the MHRA device safety information (which if targeted to you requires a response) and manufacturers’ field safety notices (FSNs).

EMA timetable for AA of full MAAs for ATMPs

EMA has published a new timetable for Initial (full) MAA under accelerated assessment for ATMPs.

Here is a link to the document: