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Focus on Regulation

EMA publishes external guidance for clinical data publication

On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use.

Policy 0070 was developed by the EMA on 2014. EMA believes that there is a need to provide with further guidance to the pharmaceutical industry in relation to this policy.

Policy 0070 is composed of two phases. Phase 1 concerns only the publication of clinical reports and Phase 2, which will be implemented at a later stage, concerns the publication of individual patient data. The external guidance document concerns only Phase 1 of Policy 0070 andĀ governs the publication of clinical trial data.

Policy 0070 provides that publication of clinical reports can take place within the frame of a marketing authorisation application (“MAA”) or within a procedure under Article 58 of Regulation 726/2004 through which the EMA may provide a scientific opinion within the context of cooperation with the World Health Organisation for the evaluation of certain medicinal products for human use intended exclusively for markets outside the EU. Clinical reports can also be published under Policy 0070 for the extension of an indication or after a request by EMA or if they have been submitted by a third party in the context of a MAA.

The external guidance document provides that all clinical reports submitted as part of a regulatory application should be published. However, regulatory applications can contain cross-references to clinical study reports submitted in regulatory procedures that do not fall within the scope of Policy 0070. Under these procedures, publication will be only clinical study reports cross referred to:

  • Extension of indication concerning the paediatric population or modification of a paediatric indication
  • Extension or modification of indication and line extension applications other than paediatric

Furthermore, to provide clarity on the application of Policy 0070 the external guidance document provides a number of definitions. These include the definition of aggregated data, clinical reports, clinical data etc..

Policy 0070 will apply to post-authorisation procedures on a later date.