Updated EU eCTD Validation Criteria

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The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force September 1, 2018.  The changes in the validation criteria relate mainly to change requests received from regulatory bodies and taking experiences with version 6.1 into account.  Click here for the Release Notes for the EU eCTD Validation Criteria version 7.0/7.1.

eCTD EU Module 1 Specification has been updated to reflect clarifications, and the updated version 3.0.3 is now available. Version 3.0.3 enters into force immediately and it is recommended to be used as soon as possible.

At Synchrogenix, we pride ourselves on staying up to date on regional authority updates to eCTD validation criteria, which is why we are a partner with industry insight you can trust. We leverage our expertise in regulatory strategy, science, and solutions to guide sponsors through the regulatory maze, saving them time and costs. With two offices in the United Kingdom (Daresbury and London), we can help organizations navigate through the EMA’s transition to Amsterdam, in addition to the array of services and solutions we offer clients in Europe and elsewhere around the world, including:

Visit our website today to learn more or email us at contactus@synchrogenix.com.


Author: Rob Labriola

Rob Labriola has 20 plus years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understands the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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