Europe’s drug agency will publish clinical trial data for new products from 2014BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e8061 (Published 26 November 2012) Cite this as: BMJ 2012;345:e8061
- Ingrid Torjesen
The European Medicines Agency has committed itself to publishing full clinical trial data submitted by companies for a clinical product once it has recommended granting marketing authorisation for that product.
The commitment will apply only to products that complete the marketing authorisation process from a set date, expected to be 1 January 2014. It will not apply to products granted marketing authorisation before this date.
This means that the agency will not have to make data available on cases of sudden death after a first dose of the multiple sclerosis drug fingolimod or safety data on …