US FDA has announced new drug registration guidelines of pharmaceutical product for eCTD submission- Module 1 Specification version 2.3 and eCTD Validation Criteria, version 3.1
The Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptation of Pilot eCTD from October 2014 and authority has scheduled to receive the eCTD submission from May 2015.
The following National Competent Authorities such as Estonia, Iceland, Liechtenstein, Slovenia are now ready to receive Centralised Procedure submissions via the Common Repository only means no longer accept Centralised Procedure submissions on CD or DVD or via CESP. This will apply to all types of Centralised Procedure eCTD procedures, including ASMF submissions related to centrally […]
From June 20, 2014, the US FDA Stability guidance for ANDA submission will require 3 batches for every strength (three industrial scale or two industrial and one lab scale) and 6 months of accelerated stability Note: If 6 month accelerated stability show significant change and failure of any attribute, 6 month of Intermediate data are […]
In January 2014, CESG (Common Electronic Submission Gateway) is part of ESG for regulatory submission of medicinal product to Canada means Health Canada is participating with the US FDA, to reduce regulatory burden for health products as part of the Canada-U.S.
The European Medicines Agency (EMA) reminds marketing authorization holders that from 1 March 2014 the use of the eSubmission Gateway or web client has become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralized procedure
The EU eCTD M1 Specification v2.0 and Validation Criteria v5.0 will be required by EMA and National Competent Authorities in EU from 1 September 2013.
The Drug sector at the Saudi Food and Drug Authority (SFDA) declared that from 5th Jan 2013 either eCTD or NeeS can be submitted and from 4th Jan 2014 preferred to provide eCTD. Finally, starting from 03rd Jan 2015 only eCTD will be accepted.
What is ESG (Electronic Submission Gateway)? The ESG has been setup by FDA for transfer of regulatory information in the form of eCTD, SPL, eDMF, etc.. The new Agency Gateway will enable the FDA to process regulatory information through automated mechanisms while it enables:
Study tagging file (STF) is an xml which contains the group of files for a particular study. Study tagging files are required and applicable in US. Study tagging files applies to only module 4 and module 5 of eCTD.