MHRAs reply to Hedley's FOI request and open letter—it didn't say anything new...
...and it didn't answer the burning question!
MHRA replied on time
Some of you may remember this Freedom of Information request I put in to MHRA on 14th November:
FOI request and open letter to MHRA—please share far and wide...
The reply came back yesterday and I replied today.
It wasn’t very convincing
In spite of the timeliness, it didn’t tell me very much. This is it:
“FOI 22/1125
Dear Hedley Rees,
Thank you for your email with attachment concerning : PART IV “Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products (ATMPs)”
By way of background it might be helpful if I explain that recitals 17 and 21 of the main ATMP Regulation 1394/2007 reports that:
“(17) The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal produc…