Regulatory Focus™ > News Articles > EMA Launches Pilot Program for Electronic Applications

EMA Launches Pilot Program for Electronic Applications

Posted 12 March 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) launched a new pilot program on 12 March for submitting centralized marketing authorization applications (MAAs) via an electronic application.

"The pilot is 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," said the agency in a statement. "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."

The guidance document details how pharmaceutical companies may apply for MAAs and renew existing applications using an interactive Portable Document Format (PDF) form.

All parties interested in participating should email with their name, job title, organization and email address.

The four-month pilot program will run until mid-July 2012.

Read more:

EMA Announcement - European Medicines Agency launches electronic application form pilot

EMA Guidance - Electronic Application Forms pilot guidance

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