- About Us
- Advertise
- Contact Us
- Editorial Info
- Editorial Contacts
- Editorial Advisory Board
- Do Not Sell My Personal Information
- Privacy Policy
- Terms and Conditions
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Regulatory Roundup: EMEA Reminds Industry of e-CTD Deadline
ePT--the Electronic Newsletter of Pharmaceutical Technology
The European Medicines Agency issued a reminder about the Jan. 1, 2010 deadline for e-CTD submissions.
The European Medicines Agency (EMEA) has issued a reminder that the electronic Common Technical Document (e-CTD) format will be mandatory for marketing authorization applications for medicinal products for human use from Jan. 1, 2010. The mandate is part of EMEA's phased introduction of e-CTDs into the centralized procedure. The agency first began accepting electronic-only submissions, with no additional requirements for paper copies, in July 2008, and on Jan. 1, 2009, EMEA strongly recommended that all submissions be electronic.