Compliance with EU M1 v3.1 and validation criteria v8.1 has been mandatory for all eCTD submissions since 1 March 2025.

It has recently become apparent that submissions to the European Directorate for the Quality of Medicines & HealthCare (EDQM) that do not contain the now mandatory tracking table in the correct location would be in breach of rule 15.11 and 15.12, despite these rules not applying to EDQM submissions (the EDQM does not use this tracking table).

It has therefore been decided that, until a new version of the EU eCTD M1 package is issued, the EDQM will accept submissions made using validation criteria v8.1, despite the fact that they will not be compliant with the above-mentioned rules.

Furthermore, the EDQM will continue to accept submissions made using validation criteria v7.1 until 31 May 2025. Thereafter, only submissions made using v8.1 will be accepted.

See also:

• Save the date! International conference on the EDQM’s CEP procedure
• Sterile substance CEP webinar on 4 June 2025
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