Active Substance Master File Working Group

The Joint Committee for Medicinal Products for Human Use/Committee for Medicinal Products for Veterinary Use/Coordination Group for Mutual Recognition and Decentralised Procedures – Human/Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary Working Group on Active Substance Master File Procedures (ASMF WG) provides advice on the procedural aspects of the assessment of active substance master files (ASMFs) to the Committee for Medicinal Products for Human Use (CHMP), the Committee for Veterinary Medicinal Products (CVMP), the Coordination Groups for Mutual Recognition and Decentralised Procedures (CMDh and CMDv).

The Working Group's main tasks include:

• considering the feasibility of a worksharing procedure for ASMF assessments;
• developing a procedure for a co-ordinated and harmonised use of ASMF assessments;
• developing a European Union numbering system for ASMFs;
• developing a centralised database for all ASMF assessment reports;
• considering how the ASMF assessment procedure can be improved and optimised.

Mandate, rules of procedure and work programme

More information on the ASMF WG's responsibilities and composition are available in this document: