International – PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use.

PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, while addressing concerns related to patient safety and the proportionate regulation of ATMPs.

“Although one of the objectives of this present revision was to prepare a document that would stand for several years the field is quickly changing; it is recognised that amendments may be necessary to accommodate technological change, to clarify uncertainty or to specifically recognise important alternatives,” the draft Annex 2A says.

The document is divided into two parts related to the manufacture of ATMPs, “from control over seed lots and cell banks through to finishing activities and testing,” and another part on further guidance for specific types of ATMPs and substances…