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EMA recommends electronic submissions for drug marketing authorisation

Follows successful four-month pilot

The European Medicines Agency (EMA) has recommend companies use its electronic form to submit drug marketing authorisation applications following a successful pilot.

Firms are encouraged to download and submit interactive PDF forms to apply for initial marketing authorisations, variations or renewals for human and veterinary medicines to “simplify and speed up the application process”.

According to the EMA, benefits of this system include:

  • Improvements to the quality and consistency of data
  • Access to data in Extensible Markup Language (XML) format
  • Integrating application data with a list of controlled terms.

The pilot has been ongoing since March, 2012, initially involving human medicines before being expanded to veterinary applications.

Plans have been in place since 2003 to move away from a paper-based application process with the launch of the Electronic Common Technical Document (eCTD).

Uptake had previously been limited, due in part to the complexity of the process, but this new more straightforward method appears to have proved popular with pharma companies using them and eCTD looks set to be the standard application process from now on.

The electronic forms are available to downloads from the EMA's eSubmission website, which describes them as an “alternative, convenient, online version of the currently used paper forms”.

Also available on the eSubmission website are user guidance forms about the electronic process and Data Exchange Standards and XML Schema Definitions documents that are intended to allow software developers within other organisations to develop systems to process the electronic application form data and build equivalent systems, if required.

27th July 2012

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