eCTD submission

National implementation of EU eSubmission roadmap – information from UK MHRA and CZ SUKL

As a first milestone, the submission of new marketing authorization applications in the Decentralized Procedure must be done using the eCTD format from 1st of July 2015 onwards.

In line with EU eSubmission roadmap the UK MHRA and the CZ SUKL have released national statements to underline the milestones as set forth in the roadmap.

See more at:
For UK (MHRA)
https://www.gov.uk/government/news/mandatory-use-of-ectd-for-decentralised-procedures

For CZ (SUKL)
http://www.sukl.cz/leciva/povinny-ectd-format-registracni-dokumentace-1

Author

KnetAdmin

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