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 ...

All regions that have published guidelines will mandate implementation of eCTD version 4.0 by 2028, with more regions to follow in the future Developed by the International Council for Harmonisation ...

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 ...

With an approaching deadline of 1 January 2019, Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files (DMFs) using the electronic common ...

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) ...

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 ...

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 ...

After years of transitioning in the requirement for drug and biologics sponsors to submit applications to the U.S. FDA in the electrical common technical document format (eCTD), the agency is getting ...

BOCA RATON, Fla.--(BUSINESS WIRE)--Akron Biotechnology, which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and ...