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EMA pilots electronic regulatory submissions

European regulator looks to kick-start delayed moves towards accepting the eCTD as standard

The European Medicines Agency (EMA) has launched a four-month electronic submissions pilot that will allow pharma companies to file centralised marketing authorisation applications using an interactive PDF form.

It marks an attempt by the European regulator to kick-start its delayed move towards accepting electronic applications through the Electronic Common Technical Document (eCTD) as standard.

The eCTD has been available for pharma to use, in parallel with companies' paper submissions, since June 2003, but uptake has been limited because of the complexity of the process.

The EMA said the pilot, and ultimately the transition to accepting the eCTD as standard, 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
• Integrating application data with controlled vocabulary lists

The pilot will initially offer access to the human medicines electronic application forms, which are supported by Data Exchange Standards documentation, XML schema definitions, and user guidance. A second phase will provide access to veterinary medicines electronic forms

If the EMA's pilot is judged a success the regulator expects that electronic application forms will become an alternative, recommended format for submitting eCTD applications to the EMA.

The electronic application forms for the pilot were published yesterday and their content is identical to that of the current application forms published by the European Commission in the EudraLex – Volume 2. The electronic application forms will be updated in parallel to any update of EudraLex – Volume 2

The forms were developed by the European Medicines Agency, working together with the European Commission services and medicines regulatory authorities in European Union Member States.

Questions about the pilot can be addressed to the electronic applications service desk by emailing eaf@ema.europa.eu and full details on how to register for the pilot are available on the electronic application form pilot website.

13th March 2012

From: Marketing

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