A concept paper on the revision of Annex 15 has been published on the EMA’s website.
One of the main objectives of the revision is to make the application of Annex 15 mandatory for active substances (APIs).
Until now, its application has been optional for active substance manufacturers. This change will affect both manufacturers of chemically synthesized and biologically derived active substances. In addition, the updates to Quality Risk Management introduced in ICH Q9 (R1) will be incorporated.