Q1: How do I get involved in eSubmission?

A: eSubmission is an evolving area where ICH, EMA and National Competent Authorities, with input from Industry, are developing standards and guidelines, incrementally. This web site provides access to information about various eSubmission projects and National Agency initiatives. The ICH and European standards and guidelines are managed via a Change Control process. Change Requests or Q&As (Questions and Answers) can be raised in order to change or clarify the standards or guidelines in order to make them clearer or to improve them.

Please send all FAQ for publication on this site to: eCTD@ema.europa.eu

For specific questions and answers, please refer to the EU Telematics EU eCTD Change Request/Q&A Tracking Table

For FAQ relating specifically to Veterinary Applications, refer to the FAQ document provided by the TIGes Veterinary Subgroup