A meeting has been held by US-Food & Drug Administration for explaining the concept of new FDA form 3938 for the submission of Drug Master File to FDA. The agenda for the meeting was to explain the concept of Form 3938, the details of the form, purpose of the form, when should the form 3938 […]
The US Food and Drug Administration’s (FDA or Agency) has announced the date that they will no longer support electronic submissions using the Electronic Common Technical Document (eCTD) Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional Document Type Definition (DTD) Version 2.01 after March 1, […]
TGA updated guidance for the baseline submission for converting their dossier format from paper, Common Technical Document (CTD) or Non-eCTD electronic Submission (NeeS) to electronic Common Technical Document (eCTD).
The UK has left the EU, and the transition period after Brexit comes to an end this year. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021. From 1 January 2021, the MHRA will be […]
Switzerland’s regulatory authority Swissmedic updated guidance on submitting regulatory information in eCTD format to the Swiss Agency for Therapeutic Products.
After successful Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format in the pilot in August 2019, Health Canada begins implementation of Clinical Trials regulatory activities in eCTD format.
The FDA has finalized guidance documents on eCTD submission format for eCTDv4.0 Technical Conformance Guidance and the FDA eCTDv4.0 Module 1 Implementation Package.
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 […]