Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format ...

Health Canada is announcing its intent to shut down a pilot project currently used by sponsors who still wish to submit common technical documents (CTDs) in their physical format instead of the ...

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "eCTD Submissions - Fundamentals and Process" training has been added to ResearchAndMarkets.com's offering. eCTD Submissions, or electronic Common ...

A long-awaited draft guidance requiring the submission of most pharmaceutical and biological product applications to be done using the electronic common technical document (eCTD) standard has been ...

In 2005, the heads of the European medicines agencies agreed that all EU member states must have the infrastructure and processes in place to handle only electronic Common Technical Document (eCTD) ...

DUBLIN, Aug. 29, 2019 /PRNewswire/ -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. This two day workshop will ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Joshua Boutwell, President and CEO of Aquila Solutions said, “We are pleased that our expertise in eCTD authoring is now available to everyone. We know our eCTD Templates will help sponsors save time ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

The European Medicines Agency (EMEA) has set a timetable for the implementation of electronic-only applications for marketing authorisation through the centralised approvals procedure. The European ...