MHRA has replied to Hedley's FOI 22/1125—they want a Teams call...

...but I'm not falling for that one!

More on FOI 22/1125 

In a previous post, we focussed on an FOI request to MHRA, asking about a concerning change to regulations applying to advanced therapies only (include gene therapies). The answer was unconvincing to say the least—check it out here:

MHRAs reply to Hedley's FOI request and open letter—it didn't say anything new...

This is my reply, extracted from the link above:

“Dear MHRA Customer Services,

Thank you for this timely response to the FOI submitted on 14th November 2022 – much appreciated. Unfortunately, however, it does not provide convincing answers to the questions raised, explained as follows:

The questions relate to a substantial change in the 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide). This is in regard to reconstitution activities applicable to ATMPs only from January 2022 onwards.

You will know that The Orange Guide has a long history of being the GMDP ‘bible’ for practitioners operating in pharmaceutical …