EMA adopts open trial data policy to begin Jan. 1 - FierceBiotech

"The European Medicines Agency (EMA) adopted a new policy on Oct. 2 that requires drug companies to make public certain clinical data that predicate drug approvals. Intended to do away with long-standing secrecy in clinical trials, the transparency policy will be be rolled out in two phases. Beginning Jan. 1, the plan will impact companies that submit drugs for approval to the European regulator on or after that date. For existing medications that are approved for new indications, the rules take effect next July. The final version of the rule eliminates some restrictions that were in a draft version after open data advocates and scientists criticized the EMA for backpedaling on its original promise of an open data initiative ..."