In this article we provide you with an overview of useful tools and channels regarding eCTD.
Drug Regulatory Fee Calculator
The Regulatory Fee Calculator provides cost estimates for activities such as marketing authorisation applications or variations, across the European Economic Area (EEA).
Fee information from the regulatory authorities is checked biweekly and the database entries are updated with best price estimates. Additional advice such as price tolerances is added to the comments field. The service is currently free of charge and provided by Xendo Deutschland GmbH.
emainfo is the European Medicines Agency's YouTube Channel. They publish videos on different EMA related topics.
There are various groups regarding eCTD on LinkedIn in which the members post the latest information about eCTD.
- eCTD Regulatory Submissions Network
- European Regulatory Affairs Association
- Regulatory Submissions - eCTD, SPL/PLR, RIM
- eCTD Professionals Network
- Global Regulatory Affairs