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  • Regulatory NewsRegulatory News

    Electronic Application Forms Mandatory for EU Centralized Procedure

    Beginning today, the European Medicines Agency (EMA) will require companies to use new electronic application forms (eAF) for all medicines applying to the centralized procedure. Background In March 2012, EMA piloted the use of electronic application forms as part of its efforts to modernize the marketing authorization process. Since then, EMA has allowed companies to submit their initial marketing authorization applications in either electronic or paper format. Then i...
  • Regulatory NewsRegulatory News

    EMA Holds Final Round of Testing Before New Electronic Forms are Required

    The European Medicines Agency (EMA) is conducting user-acceptance testing of new electronic application forms (eAF) in preparation for the transition to electronic-only applications on 1 July 2015. Background In February, EMA announced it would require all new human and veterinary medicines using the centralized procedure, including variations and renewals, to use eAFs as opposed to paper applications. EMA began using electronic application forms for marketing au...
  • EU Regulators Expand Electronic Submission Program, Recommend Wider Use

    After a four-month pilot period, EU regulators are proposing to make permanent a program that allows applicants and sponsors of marketing authorization applications to submit their entire dossiers electronically. The European Medicines Agency's (EMA) 27 July statement on continuing the electronic application form (eAF) pilot program says the testing phase was "successful," and use of the program will allow sponsors and applicants to better control the quality and consist...