Thursday, 9 October 2014

More light shed on clinical trials data

On 2nd of October 2014 the European Medicines Agency (EMA) Management Board unanimously adopted the new policy pursuant to which the clinical reports that underpin the decision-making on medicines will need to be published (Publication of clinical reports). This measure is to become effective as of 1 January 2015 and will apply to all applications for centralized marketing authorizations submitted after that date. EMA will thus increase transparency of clinical trials prior to May 2016 when the new rules on clinical trials may enter into force (see our previous post: New rules on clinical trials - adopted). The quest for granting access to this data has been long-lasting and had many obstacles on its path, but the pharma industry finally decided to co-operate with the academics and consumer advocates and allow them to re-evaluate the data of clinical trials. The individual patient data will not be revealed and any information that could be perceived as commercially confidential will be redacted. BEUC welcomed the news, however, it finds it 'deplorable' that pharma companies may still use the guise of commercially confidential information to avoid revealing all their data (Clinical trials transparency partially boosted by EMA).

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