EMA delaying implementation of data transparency policy

As expected, EMA said it will delay the implementation of its policy to proactively release clinical trial data. The agency had been planning to make summary data publicly available with no restrictions starting Jan. 1, 2014, with controlled access to de-identified patient-level data slated to start Jan. 1, 2015. Last month, EMA said it might delay implementation of the policy because it needed more time to sort through the over 1,000 comments the agency received on a draft policy released in June. EMA's management board is now expected to discuss the policy and an implementation plan at its March 19-20 meeting (see BioCentury, Dec. 9).

Two suits challenging EMA's transparency policy and the agency's decision to grant access to raw, patient-level data are also ongoing. Earlier this month, the VP of the European Court of Justice annulled an interim order that prevented EMA from releasing documents in connection to the suits (see BioCentury Extra, Dec. 5). ...