After a four-month pilot period, EU regulators are proposing to make
permanent a program that allows applicants and sponsors of marketing
authorization applications to submit their entire dossiers
electronically.
The European Medicines Agency's (EMA) 27 July statement on continuing
the electronic application form (eAF) pilot program says the testing
phase was "successful," and use of the program will allow sponsors and
applicants to better control the quality and consistency of the data in
their submissions.
Applicants will still be allowed to use paper-based forms, through
EMA said it is "recommending" the use of the electronic application
forms, which may be used to apply for initial authorizations, variations
and renewals.
The pilot phase of the program
was first launched on 12 March 2012 by EMA, which said at the time that
the program was a "key step forward in the Agency's drive towards the
use of electronic applications as standard, using the Electronic Common
Technical Document (eCTD) format."
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