FDA releases PDF specifications version 4.0

FDA releases PDF specifications version 4.0

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Romania to join the Common Repository to receive Centralised Procedure submissions

Romania will join the Common Repository to receive Centralised Procedure submissions from 1st January 2015. The majority of the NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository from 1st July 2015.
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FDA Launches Industry Basics Website

As part of its transparency initiative, which began in June 2009, FDA launched a website during the first week of January 2011 that addresses basic questions for industry about regulated products. The site addresses questions, such as, “How do I know if my product is regulated by FDA?” and “What should I expect during an inspection?”

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KnowledgeNET and upcoming market trends in the EU

“From 1, April 2009, only electronic dossiers will be accepted. Paper dossiers must no longer be submitted.”

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