Regulatory Roundup: EMEA Reminds Industry of e-CTD Deadline

September 10, 2009

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.