EFFECTIVE immediately, the European Medicines Agency (EMA) has announced open access to clinical reports for new medicines for human use authorised in the European Union.
Vytenis Andriukaitis, European commissioner for health and food safety said, "Transparency is an essential component in clinical research.
"Its outcome -- whether positive or negative -- should be made publicly available.
"EMA's transparency initiative will make Europe a true front runner with respect to release of data concerning clinical trials."
In addition, this move will create a "bridge from now until the new Clinical Trials Regulation", he said, when further milestones towards transparency will apply.
By freeing up access to the data, patients and healthcare professionals will be able to find out more information about the data underpinning the approval of medicines they are taking or prescribing.
It will also support researchers and academics after approval of a medicine, increasing scientific knowledge, and potentially further inform regulatory decision making in the future.
The EMA also believes this will enhance innovation as shared knowledge about a medicine helps developers learn from the experience of others and can lead to more efficient medicine development programmes.
The EMA says it consulted "extensively" with all stakeholders concerned, aiming to integrate their "sometimes divergent views", some innovator companies expressing fears around commercial-in-confidence data.
Visit ema.europa.eu for more.
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