Clinical data for two more medicines now available online

News 21/12/2016

EMA updates industry guidance on submission of clinical data for publication

The European Medicines Agency (EMA) has published today clinical data for two additional medicines on its clinical data website, which now totals six products. This further publication follows the launch of the website on 20 October 2016 and is in line with the Agency's policy on the publication of clinical data (Policy 0070).

Praxbind is a new medicine used to rapidly stop the anticlotting effect of dabigatran (the active substance of Pradaxa) before emergency surgery or in case of life-threatening bleeding.

The clinical data for Tarceva correspond to a variation to the marketing authorisation to modify the existing indication in non-small cell lung cancer (NSCLC) to limit maintenance treatment to patients whose tumours harbour an EGFR-activating mutation.

The Agency has updated the external guidance on the implementation of its policy on publication of clinical data based on experience gathered to date. The main changes are listed in a PDF icon separate document and were presented to industry associations at a webinar held on 9 December. The Agency will likely implement further updates in the external guidance as it gains more experience in the implementation of the policy. It will liaise with industry associations on a regular basis to clarify any future proposed changes in a timely manner.

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