Tag: Validation

ARIM Publisher, eCTD, EMA, Regulatory Update

Regulatory Update: EMA eCTD Specifications 3.0.2 – Best Practices Limitation Corrected (even better practices!)

On April 6, 2017, EMA issued a new version of the eCTD specifications, version 3.0.2, 11 months after version 3.0.1. If you look at the EMA Website’s EU Module 1 page, it appears that nothing has happened: The same EU Regional DTD (the structure of the eCTD), and the same Implementation Guide are listed as …