Regulatory Focus™ > News Articles > EU Regulators Expand Electronic Submission Program, Recommend Wider Use

EU Regulators Expand Electronic Submission Program, Recommend Wider Use

Posted 30 July 2012 | By Alexander Gaffney, RAC 

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."

"This is expected to simplify and speed up the application process by improving data quality and consistency, providing access to data in Extensible Markup Language (XML) format, and integrating application data with controlled vocabulary lists," EMA continued.


Read more:

EMA - Electronic application forms fully available for use


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