FDA eCTD Review Process Q&A

Earlier this week, GlobalSubmit and Cato Research held an educational webinar on the FDA eCTD Review Process. The purpose of the webinar was to provide an overview of the various steps and stages that a drug application goes through in order to be approved by the FDA and marketed in the United States. During the webinar, GlobalSubmit’s CTO Jason Rock discussed the FDA’s workflow, the challenges they face in the electronic...

Read More

EMEA Electronic Application Forms, Swissmedic M1 Specification

EMEA has released new versions of their electronic Application Forms (eAF) as part of Volume 2B – Presentation and content of the dossier. All three forms (for new applications, variations and renewals) have been posted. Updates are due to changes in the Data Exchange Standard Definitions released July 2009. Changes are significant, so if you have done any custom development around the eAF, you will need to make a number of updates....

Read More

EMA to Release New Module 1 Specification (v1.4) in August

EMEA has announced that they will be releasing a new M1 eCTD specification in early August. EMEA will be releasing version 1.4, including a new DTD, implementation guide, transition guide, and validation guide.  According to Claire Holmes of EMEA, this new version will accommodate recent updates to guidance on variations. The new version will be recommended from January 2010, and mandatory from February 2010. Gary Gensinger of the FDA...

Read More

Swissmedic Publishes M1 eCTD Specification, Validation Criteria

SwissMedic has issued a package of eCTD related specifications Swiss M1 Specification for eCTD Other Documents (DTD/MOD) Swiss eCTD Validation Criteria I have only done a cursory analysis as my day job is a bit overwhelming at the moment. The specification differs notably from the EMEA spec in several areas: SwissMedic has issued their own file and folder naming conventions for M1 as of course their M1 contents differ from EMEA Module...

Read More

Swissmedic Outlines Early eCTD Specifications

SwissMedic has added new information to its website on their plan for accepting eCTDs. Some key points: Swissmedic intends to accept authorisation applications in the eCTD format, i.e. in electronic form and with no paper documentation. In doing so, Swissmedic aligns itself with the EMEA road map for implementing eSubmissions in the EU Member States (Centralised procedure). Electronic submissions are to be accepted in eCTD format only...

Read More