Validation criterion 16.3 for eCTD submissions has been extended to exempt also m1.0 from some PDF checks as m1.0 is mentioned in criterion 16.4 specifically due to the PASS form.

Validation criterion 16.3 for eCTD submissions has been extended to exempt also m1.0 from some PDF checks as m1.0 is mentioned in criterion 16.4 specifically due to the PASS form. The updated eCTD validation criteria and related release notes are now available.
Validation criterion 3.3 for NeeS submissions has been extended to exempt also m1.0 from some PDF checks as m1.0 is mentioned in criterion 3.4 specifically due to the PASS form. The updated NeeS validation criteria and related release notes are now available.
The EU Harmonised Technical Guidance for ASMF Submissions in eCTD format (version 2.1) has be edited in chapter 4 to clearly address rules on how to submit Letter of Access.