MHRA, EMA and the CHMP
What a tangled web on (non)regulation
Here is some info on the MHRA and the EU/EMA’s CHMP when it comes to authorising medicines, devices etc in the UK.
This is the CHMP - Committee for Medicinal Products for Human Use.
https://www.ema.europa.eu/en/glossary/chmp
https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp
I have sent the MHRA a general e-mail information request (not an FOI) asking them if my understanding is correct, that if the EU authorises something under the CHMP system then their is zero requirement for the MHRA to do any research or investigation themselves. Awaiting an answer.
These are the 4 covid vaccine web pages from the UK Government:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen
This is what in FOI and after FOI the MHRA keep referring to as the only documents they used to confirm the “safe and effective” conclusion.
If you look close the Pfizer and AZ pages are slightly different from the Moderna and Janssen vaccination.
The Pfizer and AZ pages contain different assessment reports, they are the full (ha ha) MHRA reports which are almost copy and pasted direct from the EMA’s public assessment reports (which are interesting reading in themselves) and not truncated like the Moderna and Janssen reports.
This is due to this statement in these files:
"This product has been authorised by the MHRA in Great Britain (consisting of England, Scotland and Wales). This procedure follows a European Commission (EC) decision on 11 March 2021 (EMEA/H/C/005737), in accordance with the advice from the Committee for Medicinal Products for Human Use (CHMP). This is known as the EC Decision Reliance Procedure.”
This statement is NOT in these files:
This statement is also supported in an e-mail I sent about the batches that had been authorised for use as per the EUA terms:
No batches of the Moderna and Janssen vaccines were authorised under Regulation 174, as these were granted marketing authorisations following a European Commission (EC) decision."
So NO MHRA authorisation or further investigation required by the MHRA as “the EU/EMA said it was OK”.
"So NO MHRA authorisation or further investigation required by the MHRA as “the EU/EMA said it was OK”."
What's interesting is this bundle of lies by the MHRA is exposed by the EMA Leak documents, as the EMA said they were trying to keep pace with a rapid MHRA decision, and not the other way around.
Of course, with the UK exiting the EU, Regulation 174 - an EU regulation - no longer applies. 'Because someone else approved it' is terrible decision making.
Many thanks for uncovering all this.