EMA begins pilot for electronic drug applications
pharmafile | March 14, 2012 | News story | Medical Communications |Â Â EMA, European Medicines Agency, eCTDÂ
The European Medicines Agency has launched a pilot scheme that allows pharma firms to submit new drug applications electronically.
The pilot runs for four months until mid-July, and allows pharma to apply for initial marketing authorisation applications for their medicines using a PDF form.
Companies can also use this new process for variation and renewal applications for both human and veterinary medicines.
The forms were developed by the European Medicines Agency, working together with the European Commission services and medicines regulatory authorities in the EU.
The EMA says that the pilot is ‘a key step forward’ in its drive towards the use of electronic applications as standard, using the Electronic Common Technical Document (eCTD) format.
The overall aim is to simplify and speed up the application process, primarily by improving data quality and consistency.
Full details on how to register are available here.
Ben Adams is the reporter for Pharmafocus and InPharm.com and manages the DigiBlog site. He can be contacted via: email or Twitter.
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