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
A revision of the EU eCTD Module 1 Specification has taken place and is now published as a draft version 3.0 for public consultation: Read More
At the ICH M8 EWG meeting in November 2014, the Steering Committee endorsed the M8 EWG to post the ICH eCTD v4.0 DRAFT Implementation Guide v2.0 and related files for regulatory consultation. These documents are now available for regulatory consultation until May 22, 2015 and can be accessed using the following link: Read More
As a regulatory affairs professional, being responsible for drug submissions is an exciting task, but it also comes with many dimensions of complexity and pressure. Recently a new technological trend, „cloud“ or „software as a service“, is creating more questions and the potential for confusion. Read More