European Medicines Agency (EMA) updated version of Technical eCTD guidance document to assist biopharma regulatory professionals and industries with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities (NCA) and the European Medicines Agency (EMA).
This guidance was initially created by the TIGes Harmonisation Group, a sub-group of the Telematics Implementation Group for electronic submissions (TIGes), and is now being maintained by the Human Harmonisation Maintenance Group (HHMG), a sub-group of the eSubmission Change Management Board (CMB). It should be stressed that this guidance reflects the current situation and will be regularly updated in the light of changes in national and/or European legislation together with further experience gained within NCAs and EMA using information submitted in electronic format. If needed, there are also Q&A documents published in between versions of this guidance as a response on change requests or new requirements to be addressed (refer to EMA eSubmission website)
This document consists of four parts:
- General Considerations
- Module Specific Information
- Advice on Specific Application Types together with associated annexes.
Some changes include:
- Description of a UUID – a unique identifier of the dossier
- Section 2.10.5, Change of terminology to reflect e Application Forms and Gateways rather than dispatch by CD/DVD
- Section 2.9.11, No more re-submission with same sequence number to solve issue
- Section 4.1, information in the table has changed for mandatory sequences. Now 15 days post decision for closing sequence vs 5 days. The Policy 70, final redacted document package has been added.
- EMA added details on PSURs and Referrals
- Glossary updated to match EU M1 guidance
The New EU Harmonized Technical eCTD Guidance (version 4.0) is available on the eSubmissions website.
Several of the changes will apply only after the 1st of July as they are pertained to the EU M1 specification v3.0. However, the updated recommendations in regards to the other parts of the guidance (e.g. Section 4) can be applied now.
Version 3.0 and Version 4.0 will both be available on the website till this month end. However, from 1 July 2016, Version 3.0 will no longer be valid.