EMA Launches Electronic Application Form Pilot
The pilot allows pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and variation and renewal applications for human and veterinary medicines, using an interactive PDF form.
The European Medicines Agency has launched a pilot of electronic application forms for submissions of centralised marketing authorisation applications.
The pilot, which runs for four months until mid-July 2012, allows pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and variation and renewal applications for human and veterinary medicines, using an interactive PDF form.
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. This is expected to simplify and speed up the application process.
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