Few Pharmas Expect to Meet EVMPD Deadline
Virtify survey reveals only 15% of big pharma, 35% mid-size pharma are optimistic about submitting all required data in time
Polling conducted by Virtify, Inc. revealed that most pharmaceutical companies are concerned about their ability to comply with the requirement to submit additional pharmacovigilance data to the EMA EudraVigilance Medicinal Product Dictionary (EVMPD) in advance of the July 2, 2012 deadline.
Attendees from 50 different pharmaceutical companies were polled during a Virtify sponsored roundtable about the likelihood that their company would meet the EVMPD deadline, given current guidance. Of the thirteen top 20 pharmaceutical companies represented, only two thought they would definitely or likely meet the deadline. 38% thought it was unlikely they would meet the deadline and over 30% thought their company definitely would not meet the deadline.
Mid-size pharmas were more optimistic, with over 35% expecting to make the deadline. 50% thought that they probably or definitely would not make the deadline, however. About half of all companies were looking to third-party solutions or technology vendors to help them achieve compliance. "We have heard from many companies that the mandate is a challenging new requirement in a very tight timeframe," said Satish Tadikonda, CEO and founder of Virtify. "These data show just how challenging it is. On the other hand, 82% of the companies thought they would definitely or probably meet the July 2 deadline if the requirement to include structured substance information was dropped."
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