EU regulators have recommended extending a pilot on the use of raw clinical trial data in medicines evaluations after an interim review of the initiative found that using such data improved regulatory decision-making.
The European Medicines Agency and EU Heads of Medicines Agencies have published interim results from a proof-of-concept pilot investigating the benefits of using raw data from clinical trials in regulatory procedures.
In the 18 October report, the EMA and HMA said that a survey of pilot participants revealed the value of...
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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