The second letter was sent in response to a reply from the European Commission. Initially PIC/S has criticised the content of the ATMP GMP Guidelines to not only lower GMP standards for ATMP at the risk of patients but also to lead to an internationally non-harmonised approach to the implementation of GMP for ATMPs.
In its latest letter, PIC/S has reaffirmed its position and highlights again gaps relating to patient safety. Besides other concerns expressed therein, this major concern of PIC/S and its members has obviously not been taken into account by the EC so far.
This time an Annex was enclosed to the letter that details a non-exhaustive summary of critical outstanding points that could be of risk to patient safety.
Obviously the EC has proposed to explain and discuss the draft Guidelines with non-EU PIC/S Members, as PIC/S is responding to that matter and is asking for the next steps to be taken. “A reply to our proposal for a joint Working Group has not been received” it says in the letter. Furthermore it is said that “Clarification on the scope of the co-operation you propose would be welcome. It would also be appreciated if the latest version of the draft Guidelines could be shared as soon as possible to allow us at least to comment prior to publication. A discussion after the finalisation and publication of the Guidelines would have little purpose.”
Another important concern that has been addressed once more was the risk of de-harmonisation should it come down to lower GMP standards for ATMPs. PIC/S and its members fear that this could lead to serious consequences to the current global regulatory framework.
The enclosed Annex lists a summary of 17 critical points impacting patient safety.
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