EMA publishes ATMP action plan

EMA and EC's Directorate-General for Health and Food Safety (DG SANTE) published a joint action plan intended to foster development of advanced therapy medicinal products (ATMPs), which include therapeutic products made from genes, tissue or cells. The plan's 19 initiatives are intended to streamline ATMP regulatory procedures.

EMA intends to issue several scientific guidelines on ATMPs, including guidance on gene therapies this quarter, a draft revision of a guideline on genetically modified cells in 1Q18, and guidance on gene editing considerations in 2Q18...