My video meeting with MHRA leaves questions unanswered—why are gene therapies getting special treatment?

Could it be to clear the way for wall-to-wall mRNA injections?

Teams call today

I had a Microsoft Teams call with Ian Rees, MHRA’s Manager for the Inspectorate Strategy and Innovation Unit and David Olszowka, Senior Regulatory Advisor, Inspection, Enforcement & Standards Division.

I first met Ian Rees in 2012 when the MHRA was in London, Victoria. His boss then, Mark Birse, had agreed to meet me and I gave both of them a copy of Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics. It was 75 quid even in those days—that’s how generous I am :O)!

Mark Birse left to become Vice President, Technical, Regulatory Consulting Services with Parexel, a large Contract Research Organisation (CRO).

Note: Pharma companies cannot develop drugs without CROs doing the legwork. Same for development and manufacture, they need Contract Development and Manufacturing Organisations (CDMOs). Check out the latest MHRA escapee joining the world’s largest CDMO as Global Head of Sterility Assurance, Cell and Gene Technologies, David Churchward.

Hopefully, you are beginning to get the direction of migration…

FOI and open letter

Returning to the subject at hand. Some of you will remember the FOI and open letter I submitted to MHRA last November:

Subject: FOI Request—Chapter 8, EU Guidance and UK Guidance on Wholesale Distribution in the 2022 edition (current) of Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022

I reported on some shocking news received during an initial exchange of emails, below:

MHRA confirms that hospital pharmacies can manufacture, transport and store gene therapy products, and the Care Quality Commission will be responsible, not MHRA

This is an extract:

“The January 2022 change to the regulations, for ATMPs only, allow for a hospital pharmacy to carryout additional processing operations (under the title ‘Reconstitution’, please refer to the original FOI for full details).