The EMA has decided to publish clinical reports that underpin the decision-making on medicines. Following extensive consultations held by the agency with patients, healthcare professionals, academia, industry and other European entities over the past 18 months, the EMA management board unanimously adopted the new policy Oct. 2. It will apply to clinical reports contained in all applications for centralized marketing authorizations submitted after that date. The reports will be released as soon as a decision on the application has been taken. The policy will enter into force in January 2015.
The policy will be implemented in phases. The first phase starts in January 2015. Once a medicine has received a marketing authorization, EMA will publish the clinical reports supporting applications for authorization of medicines submitted after the policy’s entry into force. For line extensions and extensions of indications of already approved medicines, the agency will give access to clinical reports for applications submitted as of July 2015 after a decision has been taken.
“The adoption of this policy sets a new standard for transparency in public health and pharmaceutical R&D,” said Guido Rasi, EMA executive director. “This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”
The new EMA policy will serve as a useful complementary tool ahead of the implementation of the new E.U. Clinical Trials Regulation that will come into force not before May 2016. EMA expects the new policy to increase trust in its regulatory work as it will allow the general public to better understand the agency’s decision-making. In addition, academics and researchers will be able to reassess data sets. The publication of clinical reports also will help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.
In future, EMA plans to also make available individual patient data. To address the various legal and technical issues linked with the access to patient data, the agency will first consult patients, healthcare professionals, academia and industry. It is critically important for EMA that the privacy of patients is adequately protected before their data are released.
The policy does not replace the existing EMA policy on access to documents. It will be reviewed in June 2016 at the latest.