Just as pharma's frontrunners come into view with proposals to substantially advance the clinical trial data debate the EMA moves to address some of its own transparency issues.
The Agency has, for the first time, scraped away some opacity from its inner workings and begun publishing meeting minutes for its Committee for Medicinal Products for Human Use (CHMP). Given that the CHMP, as we well know, issues advice on which products to approve, the move could offer an intriguing glimpse into a previously closed world.
However, the first minutes published leave a little to be desired. Information considered “commercially confidential or sensitive” is “therefore not disclosed”, along with certain, unspecified aspects of on-going CHMP discussions. So whether we should have a positive opinion on the development or request a re-examination remains unclear.
On a different note I'd like to end this month's comment by introducing the new look PME. We've given our little facelift a lot of thought and, though you'll still find the same vital combination of accessible intelligence within its pages, I hope the design changes will make it that much easier on the eye.
I'd welcome your feedback on the changes – or, for that matter, any aspect of PME – and you can contact me via email on dtyer@pmlive.com.
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