Clinical data publication

Clinical data publication

New Clinical Data Publication Policy

The European Agency proactively publishes the clinical reports submitted under the centralized marketing authorization procedure for human medicines.
The policy entered into force on 1 January 2015 and is currently being implemented.

The philosophy of this new Clinical data publication policy is in contradiction with global WW initiatives like TAFTA or with other regions regulations, especially about intellectual property or data privacy. Those contradictions will set up requirements for EU pharmaceutical companies that will not apply worldwide, and will make competition unfair.

In parallel, pharmaceutical companies are worrying about implementation of this regulation. It will lead to risks increase for them about agreements between different companies and about liability of published results.

 

New Clinical Data Publication Policy

New Eu Clinical Regulation impacts