Freedom of Information request on the Interactive Drug Analysis Profile for Molnupiravir (FOI 22/407)
Published 31 May 2022
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FOI 22/407
15th February 2022
Dear
Thank you for your email.
Please find below answers to the questions you raise.
1) When will the next MHRA Board meeting be available to the public on YouTube , the last was over 2mths ago.
The recording of the 18th January MHRA Board Meeting Held in Public has now been published and is available at this link.
There was no Board meeting held in December 2021; the previous meeting took place on 16th November. All the recordings of these meetings are available on the MHRA website at: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about/our-governance
2) Safety data and any SAR reported on Molnupiravir Merck
The Interactive Drug Analysis Profile (iDAP) for molnupiravir displays an overview of all UK spontaneous suspected Adverse Drug Reactions (ADRs) reported through the Yellow Card Scheme. It is important to note that reported adverse reactions have not been proven to be related to the drug, and should not be interpreted as a list of known side effects.
3) Information with regard to AZD442 - Evusheld and if the MHRA intend to approve it under EUA for use in U.K.
AstraZeneca has begun the rolling review process to obtain a licence with the MHRA. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data. The MHRA has been in active discussions with AstraZeneca and we have procedures in place to ensure the assessment is conducted as efficiently as possible. As this is a rolling review with data submission as they emerge and because the review is ongoing, we are unable to specify the exact date for a decision on approval.
4) Vioxx victims U.K. and any investigation MHRA are currently running - Merck
No criminal enforcement issues.
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Yours sincerely
MHRA Customer Experience Centre