eCTD

Showing 4 posts of 4 posts found.

EMA begins pilot for electronic drug applications

March 14, 2012
Medical Communications EMA, European Medicines Agency, eCTD

The European Medicines Agency has launched a pilot scheme that allows pharma firms to submit new drug applications electronically.  The …

Talking R&D: eCTD challenges

October 6, 2010
Manufacturing and Production, Research and Development Talking R&D, eCTD, eCTD submissions

The eCTD was of course developed by the ICH (International Conference on Harmonisation) Expert Working Group to make it easier, …

Talking R&D: Evolving technical standards

October 5, 2010
Manufacturing and Production, Research and Development Talking R&D, eCTD, eCTD submissions

The European Union (EU) Module 1 specification works in parallel with the ICH eCTD Specification. It was first introduced in …

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