Last update Jan 2014
PharmaQM
 
ACTIVE SUBSTANCE MASTER FILES
formerly European Drug Master Files (EDMFs)

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Active Substance Master Files

  • Advice
  • New dossiers
  • Pharmaceutical Expert reports (QOS) and signature
  • Updates to dossiers and Pharmaceutical Expert reports (QOS) and signature

By lodging an ASMF with one or more EU licensing authorities, a bulk active pharmaceutical ingredient (API) manufacturer can support its customers seeking Marketing Authorisations for a dosage form(s) involving its API.

The authorities have many CMC (chemistry, manufacturing, control) requirements for APIs, which may be produced by synthesis, fermentation or other means, followed by extraction, purification and even further down-stream modifications.

Dr Robertson has many years of experience in assessing ASMFs and wrote the internal guidelines for ASMF assessment that are used by pharmaceutical assessors in the UK licensing authority. 

He has lectured internationally on ASMFs and until he left the UK licensing authority he also had responsibilities for staff training in this subject area.

He also had responsibilities for and opportunities to train UK assessors and other staff at the EDQM about ASMFs and CEPs.  For the CEP Procedure, he originated the rapporteurs’ internal guidelines for the assessment of Products of Fermentation.