• Irish Medicines Board Announces Transition to Fully Electronic Submission System

    • 14 May 2012
    The Irish Medicines Board (IMB) is announcing its adherence to a 2005 agreement between the Heads of Medicines Agencies to transition to a fully electronic system for submitting applications, including the electronic Common Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS). IMB said in a statement the transition confers several advantages, including reduced costs, consistency of applications and information viewed across agencies, improved lifecycle ma...
  • Health Canada Looking to Transition all Submissions to eCTD Format

    Health Canada is announcing its intent to shut down a pilot project currently used by sponsors who still wish to submit common technical documents (CTDs) in their physical format instead of the now-common electronic CTD (eCTD) format. Health Canada's pilot project, which involves the sponsor filling out CTDs in electronic format and submitting them in their physical form to Health Canada, was intended to be a "transitory aid for sponsors not yet ready to submit in eCTD f...
  • EMA Expands Access to Electronic Submission Gateway Pilot to Include Veterinary Products

    The European Medicines Agency (EMA) announced 25 April it will expand access to its electronic submission gateway pilot program to include veterinary medicines. The program, dubbed the eSubmission Gateway, is an "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA. EMA had recently expanded the program, which was launched as a pilot program in January 2012, to include all human medicines after is saw "an increase in the spe...
  • Electronic Submission Gateway Goes Live for Human Medicines Submissions, Announces EMA

    The European Medicines Agency (EMA) is announcing its eSubmission Gateway-the "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA-is now up and running for all applicants for centralized marketing authorizations. The program, announced 23 April, was originally launched as a pilot program in January 2012 meant to gauge the usefulness of the electronic submission process. EMA said in a statement it has seen "an increase in ...
  • EMA Launches Pilot Program for Electronic Applications

    The European Medicines Agency (EMA) launched a new pilot program on 12 March for submitting centralized marketing authorization applications (MAAs) via an electronic application. "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," said the agency in a statement. "This is expected to simplify and speed up the application process by improving data ...