EMA – Transitioning to mandatory use of electronic application forms

Electronic submissions have become the preferred method for submitting applications for post-authorization approval among the three regions that are party to the ICH. In February 2004, ICH M2 Expert Working Group has released the eCTD Specification version 3.2, based on the ICH Common Technical Document (CTD). In the context of the implementation of the eCTD in the European Union, the Electronic Submission Telematics Implementation Group (TIGes) has developed a specification for the regional module.

The European Medicines Agency (EMA) has announced the transition to the mandatory use of electronic application forms for initial marketing authorisations, variations and renewals for human and veterinary medicines.

Any company wishing to go through the centralised procedure must use the electronic application form effective 1 July 2015.

The European Commission will remove all the application forms in Word format and replace them with the latest version of the electronic application form.  Effective 1 January 2016 the use of electronic application form is mandatory for all EU procedures, including national procedures.

“The Electronic Application Forms offer an alternative, convenient, online version of the currently used paper forms, which are published and maintained on the European Commission’s EudraLex website. These electronic forms are designed to reflect and capture the same content as the paper-based application forms.”  These forms were made available to companies by EMA on July 2012 after a successful pilot phase. Significant improvements were made to the forms since its initial release, therefore a further release based on change requests will be made available this Spring.

The mandatory use of these forms is expected to reduce the administrative burden for both the regulatory authorities and the industry, while at the same time improving data quality and consistency during data entry.





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