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Health Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019.
For the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for Type III Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format.
Is it a right time to enhance the submission format for efficiency and consistency of Regulatory quality assessment? The outcome of recent discussions between USFDA (US Food and Drugs Administration) and the Pharmaceutical Science and Clinical Pharmacology Advisory suggests a positive sign.
Are you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region.
We are all aware, that the United States Food and Drug Administration (USFDA) has extended compliance date for Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format, i.e., 5th May 2018.
With the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach.
As said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The deadline for the first phase is on 5th May 2017 and for the second phase, it is on 5th May 2018. What’s there to reconsider now?
The latest announcement from the Danish Medicine Agency (DMA) specifically points out elimination plan for NeeS format and emphasizes the consequent transition to eCTD for human domain / VNeeS for veterinary domain as directed in the eSubmission Roadmap.
Are you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
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