eCTDs are now mandatory for FDA submissions

eCTD submissions become more and more mandatory in different procedures in the European Union such as:

• Centralised Procedure (CP): eCTD format mandatory since March 2014
• Decentralised Procedure (DCP): eCTD mandatory for submission of new marketing authorisation applications (MAA)
• Mutual Recognition Procedure (MRP): eCTD mandatory for submission of new MAA
• National procedure (NP): eCTD mandatory from 1.7.2018 for new MAA and from 1.1.2019 for all submissions

Additionally, eCTD has now become the standard format for submitting e.g. applications, amendments, supplements, and reports for different submission types to the FDA (U.S. Food & Drug Administration) in the United States. Deadlines and related submissions types are:

• New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs): eCTD format mandatory since 5 May 2017
• Commercial Investigational New Drug Applications (INDs) and Master Files such as Drug Master Files (DMFs): eCTD format mandatory since 5 May 2018

All eCTD submissions to the FDA must include FDA fillable forms.  Examples for a FDA fillable form are form no. 0356h (e.g. for an application to market a new drug) and form no. 1571 (for Investigational New Drug Applications). FDA forms must be signed by digital signatures. Scanned FDA forms will not be accepted.

The Electronic Submissions Gateway (ESG) is a submission tool similar like the European submission tool CESP. eCTD submissions sized 10 GB or smaller must be submitted via the electronic portal ESG. Most submissions are considered to fall within these limits. Registering for an ESG account is the first step to be ready for eCTD submissions. Further details about eCTD submissions, ESG portal and other related topics can be found at: www.fda.gov/ectd

Diapharm supports applicants and marketing authorisation holders in fulfilling these eCTD requirements – for FDA, EMA and national procedures alike. All you have to do is contact us!