News

FDA Announces Planned Update to Electronic Common Technical Document

Latest News |


Join the discussion on Regulatory Exchange
By Alexander Gaffney

The US Food and Drug Administration (FDA) announced its intent to hold a meeting to update stakeholders on the changes it plans to make to Module 1 of the Electronic Common Technical Document (eCTD), which is used to describe administrative and prescribing information for medicines.

The eCTD is a standardized application form developed in conjunction with the International Conference on Harmonization (ICH) and its member parties. Both the Center for Drug Development and Research (CDER) and the Center for Biologics Development and Research (CBER) have been using the forms since 2003, and in 2008 FDA made the eCTD the recommended standard format for submitting applications to either agency.

In that time, however, FDA said it “has become necessary to update the administrative portion of the eCTD Module 1 to reflect regulatory changes; to provide clarification of business rules for submission, processing, and review; to refine the characterization of promotional labeling and advertising material; and to facilitate automated processing of submissions.”

FDA said it plans to release revised draft documents in advance of the meeting on its website, which will reportedly include versions of documents that support making regulatory submissions in electronic format using the eCTD specifications.

The meeting will be held on 18 September 2012 at FDA’s White Oak campus in Silver Spring, MD. Meeting space will be limited to the first 350 registrations.


Read more:

FDA - Update to Electronic Common Technical Document Module 1




3 Likes