Concerns over the controversial EU guideline on good manufacturing practice requirements for advanced therapy medicinal products (ATMPs) have prompted the regulatory authorities participating in the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the World Health Organization to create a new working group to suggest possible solutions.
New Group To Resolve 'International Divergence' Posed By EU ATMP Guide
Pharmaceutical inspectorates around the world are trying to address the divergences between Europe’s good manufacturing practice guideline on gene therapy and tissue-engineered products and the international GMP guideline for such products.
