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 ...
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 ...
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 ...
Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers ...
The eCTD is rapidly moving towards the preferred, and in some cases mandated, electronic submission format world-wide. As of January 1st of this year, FDA mandated the eCTD format for all ...
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 ...
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