According to the Regulatory Affairs Professional Society (RAPS), the “The eCTD has become the standard for many regulatory agencies around the world.”
FDA’s CDER and EMA have mandated eCTD specifications for all electronic submissions. FDA is forecasting mandates for electronic-only submissions for Abbreviated New Drug Applications (ANDA) and type II Drug Master Files (DMF), Biologics License Applications (BLA) and Investigational New Drugs (IND) in 2015-2016, and today strongly encourages e-CTD format for all drug and biologic submissions.”
PDG, a world-class Regulatory Affairs Consultant and Pharmaceutical Consultant, plans to be in attendance at upcoming RAPS workshop entitled “Preparing Compliant eCTD Submission.” The workshop will be held at the RAPS Training Center in Rockville MD on August 14 and 15, 2012. Let us know if you would like to connect at the workshop, or meet over dinner the evening of August 14.
Contact PDG today for assistance with product development and regulatory strategy, whether new molecular entity (NDA/BLA) or 505(b)(2) submission.