Health Canada has been accepting regulatory activities in eCTD format since 2004. Now Health Canada will accept dossiers in eCTD format only from 01 September 2019 for the following applications.
TGA has updated RMP for the sponsors of prescription medicines and biologicals making applications to enter or vary Australian Register of Therapeutic Goods (ARTG) entries. Therapeutic Goods Administration has provided form to be submitted along with updated RMP. Use this form when submitting an updated RMP after regulatory approval. This form should be submitted in […]
Moving towards to the paperless submission of dossier, JFDA has started accepting submission in eCTD format Following the same all initial marketing authorization submission from 01.03.2019, need to be submit in Jo-eCTD format. For other submission types an announcement will be published later (a Baseline for already approved marketing authorisations will be required) Jordan (JO […]
ESG upgraded its Pre-Production WebTrader application to 2.0 version, which is also known as Phase 2 release. Upcoming ESG 2.0 – Phase 2 Release
The EU Module 1 eCTD Specification has been subsequently updated from version 3.0.1 to version 3.0.2 respectively. The following aspects are addressed: 1. Due to an update of the EMA procedural guidance regarding documents displaying tracked changes in PDF format inside an eCTD sequence the following sentence was deleted: “An exception to this rule is […]
The MCC of South Africa has released updated versions of Module 1 eCTD specification and validation criteria (version 2.0 and 2.1 respectively).
eCTD is the standard format for submitting original applications, amendments, supplements, and registration changes to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
As per guideline released on friday, FDA announces delay in submission of DMF in eCTD format until 5th may 2018
The new version of the Guideline on eSubmissions for Veterinary Products – version 2.4 together with eSubmission Validation checklist – version 2.4 and tools is published.The new VNeeS Guideline, checklist and checker will come into force on 01/07/2016.
New versions of the electronic Application Forms (eAF v. 01.19.0.1) are now available. The version v. 01.19.0.1 of the eAFs can be used from 30 November 2015 and will replace the current version of eAF v. 01.18 after a transitional period on 11 January 2016.