Australia is phasing out eCTD Specification version 3.0 on 30th June 2018. The Therapeutic Goods Administration (TGA) is making changes with eCTD validation criteria, specifically current eCTD Document Matrix (Version 2.0) which forms part of the validation criteria for the eCTD and NeeS and which is one of file downloads for eCTD version 3.1. Read More
eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format will be accepted throughout the marketing authorisation of drugs. One of the regions announcing eCTD as a mandatory format to be used for drug applications is Health Canada. Read More
Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Guidance for Industry”. FDA has addressed recommendations for eCTD 4.0. The guidance also provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions.
As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow them to reject an eCTD submission if there is non-compliance with key study data requirements.
FDA notes in their guidance “The standards apply to the following types of submissions to CDER and CBER:
In September 2016, the FDA published new deadlines on electronic submissions:
May 5, 2017: NDA, BLA, ANDA and DMFs must be in eCTD format
May 5, 2018: Commercial INDs must be in eCTD format
Since January 1st 2016, all Submission new DMF submissions to Health Canada have to be submitted in an electronic format called “non eCTD electronic-only”. In addition to the January 1st deadline, all existing DMF’s have to be replaced by an electronic version by March 31st 2016. Read More