It is hard to be an eSubmission enthusiast when you live – and work - in the EU nowadays. It is not only because the eCTD still is making it very slowly into standard submission practice even in big pharma. It is also because the reason for that is very obvious – there are no clear commitments from the EU national drug regulatory agencies to further mandate the standard. Instead, we are now maintaining two separate standards, the eCTD and the NeeS. Initially invented as a short-term interim standard to further drive the change from paper to eCTD, the NeeS proved itself astoundingly popular and robust against any intentions to retire it. Unfortunately it does not provide any structured metadata and more important any life-cycle features. Well, this is what must be accepted by now.
For More Information Please Click EU eSubmissions Michael Braun
Regards
Shakul.
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