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Active Substance Master File (ASMF) Certificate

The lifecycle of a European ASMF is often complicated, especially when supporting multiple marketing authorizations, therefore single assessment is seen as the only workable solution for both industry and the National Competent Authorities to avoid duplication of assessment and reduce workload.

Clause 93 refers to reliance "on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II” whereas Article 25 refers to reliance “on an active substance master file, an active substance master file certificate or a certificate confirming that the quality of the active substance concerned is suitably controlled by the relevant monograph of the European Pharmacopeia.”

These sections are not aligned in their meaning.

It should be confirmed that the ASMF certificate procedure will only be applicable to active substances with no European Pharmacopoeia (Ph Eur) monograph.

For active substances with a Ph Eur monograph, the Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) procedure, run by the EDQM, remains an option.


  • CEP is the dossier submitted to EDQM and undergoes review process for its approval before referencing in the MAA.
  • ASMF are submissions to European regulatory agencies across Europe in all individual countries.
  • ASMF is never approved nor disapproved, but is reviewed every time it is referenced in the MAA application unlike CEP is approved.
  • ASMF constitutes of two parts, Applicants Part (AP) and Restricted Part (RP).

Applicant’s part has the information on chemistry manufacturing and control (CMC) information of API included in it for the customer reference for its inclusion in its Marketing Authorization Application (MAA) Dossier.

Restricted Part also has the information on chemistry manufacturing and control information of API included in it for the regulatory health authority reference for its evaluation against the Dossier submitted in MAA to various European agencies through National, MRP/RUP and DCP procedures.


- Allow parties to reference material without disclosing restricted part of ASMF contents to those parties.

- Are not required by statute or regulation.

- Are neither approved nor disapproved.

APIC welcomes the introduction of an ASMF certification procedure for non-pharmacopoeial substances. This should be fully aligned with the CEP procedure and preferably overseen by EDQM. 

APIC supports the sharing of necessary information with the MA holder but strongly opposes the sharing of Restricted Part information and the full ASMF assessment report.

Read also: ASMF Single Assessment | APIC Position Paper

Resource Person: BARBARA PIROLA

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