• 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...
  • Regulatory NewsRegulatory News

    Going Digital: EMA to Ditch Paper, Require Electronic Application Forms

    In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards. Going Digital The process of transitioning to electronic systems can be complicated, especially for regulatory processes which are often highly complex.  However, electronic documents provide a num...
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    FDA Expanding Device Program Intended to Make 510(k) Submissions Easier

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is once again expanding an electronic submission pilot program meant to make it substantially easier for companies to create and submit a 510(k) premarket submission to the agency. Background As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "el...