Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials

Important MHRA survey about PPI and clinical trials

The MHRA is the organisation that regulates licensing of new drugs in the UK.
They took over from the EMA (European Medicines Agency) since Brexit.
They are now proposing to change a few aspects with regards to clinical trials.
If you have ever taken part in a clinical trial, or considered doing so – please consider answering their survey – it is really important.

MHRA Invitation:

We have just launched our 8-week public consultation on proposals for legislative changes for clinical trials.

We want to streamline clinical trial approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials.

We would like to hear from the public and patients, clinical trial participants, researchers, developers, manufacturers, sponsors, investigators and healthcare professionals to help shape improvements to the legislation for clinical trials.

You can read more about our proposals in our Press release and consultation document.

Our consultation will close at 11pm on Monday, 14 March 2022.

Patient, Public and Stakeholder Engagement team - Communications and Engagement

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 0203 080 6000
Email: engagement@mhra.gov.uk
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MDS UK note:

Our support group has been involved in an increasing amount of PPI work in the last 5 years – shaping clinical trial protocols, advising on Quality of life tools, and reviewing Patient Information documentation.

This work is providing essential recommendations for most MDS clinical trials – in order improve treatment options for MDS patients.
We plan to expand even further on this type of research work.
For this work, we need more people (patients/carers/families) willing to be trained to review such documentation.
If you are interested, or know a patient or carer who could be interested – please email info@mdspatientsupport.org.uk with “PPI” in the header.

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