Regulatory News

EMA Gearing up to Publish Clinical Data Ahead of New Clinical Trials Regulation

The European Medicines Agency (EMA) is moving forward with its plan to release the clinical data used in marketing authorization applications.

Background: Clinical Trials Regulation

In April 2014, the European Parliament overwhelmingly passed a new regulation governing clinical trials, Regulation (EU) No 536/2015, repealing Directive 2001/20/EC following a transition period lasting through 28 May 2016.

One of the major changes in the new Clinical Trials Regulation is increased transparency measures, which require clinical trials to be registered in a "publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP)."

The regulation also calls for the creation of a new, publicly accessible, clinical trials database and portal. The information submitted to the database will be made publicly available, except where certain exceptions apply:

• protection of personal data
• protection of commercially confidential information
• protection of confidential communication between Member States in the preparation of their assessment
• protection of the supervision of clinical trials by Member States

Companies are required to publish a summary of the results of all clinical trials within a year of a trial's completion. For trials used to support a product's marketing authorization, companies are required to publish the "clinical study report within 30 days after the day the marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed, or the applicant for marketing authorisation has withdrawn the application."

Publication of Clinical Data

Shortly after the passage of the Clinical Trials Regulation, EMA adopted a policy on the proactive publication of clinical data.

The policy requires EMA to publish the clinical reports used in all marketing authorization applications submitted after 1 January 2015 once the agency has made a decision on the application. Because of the lengthy nature of the marketing authorization process, EMA expects the first clinical reports released under the policy to be published in mid-2016.

Clarifying the Policy

To help clarify the new policy, EMA is holding a webinar on 24 June 2015 to inform stakeholders about the policy and the systems and principles that will be used in implementing the policy.

The agency says the webinar will also feature a discussion of "what is and is not considered commercially confidential information and on the anonymisation and redaction of personal data in clinical reports."

EMA also released a questions and answers document intended to inform stakeholders about the policy, its interpretation and implementation. The document also explains EMA's rationale for implementing the new policy less than two years before the Clinical Trials Regulation takes effect. The agency says that because new clinical trials will not have to follow the new regulation's requirements until May 2016, the Clinical Trials Regulation will likely not result in publicly available clinical reports in the next four to five years.

EMA Press Release, EMA Q&A Document