During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the MHRA and the USA regulatory authorities plus PIC/S. If you are involved in ATMP manufacture then the very strongly worded PIC/S letter to the European Commission will be of particular interest.
The topics covered in this edition of the “Update” include
Annex 16 QP certification and batch release – FAQ – part 1