Mutual recognition of GMP inspections for cell, gene and radiopharmaceutical plants

The EU-US Mutual Recognition Agreement covers inspections of most human medicines but has been slow to extend to advanced therapy medicinal products and has no equivalent with Japan, China or India for these classes. Cell-therapy and radiopharmaceutical sites face repeated inspections by multiple agencies, each a multi-week interruption. The proposal is to extend PIC/S and MRA reliance explicitly to ATMP and radiopharmaceutical manufacturing, with a shared inspection schedule and a common inspection report template.