News from the EU on transparency of clinical data

  Written on 09.03.2016

The European Medicines Agency (EMA) publishes guidance on EMA policy on the publication of clinical data.

The guidelines outline if and how the pharmaceutical industry can anonymize information from clinical reports and how to identify and redact commercially confidential information in clinical reports that are submitted to EMA.

The new guidelines have been prepared by EMA as a supplement to the guidelines on the publication of data from clinical trials conducted in order to obtain a marketing authorization that came into force last year. The pharmaceutical industry has until 1 September 2016 to make data ready for publication, and these new guidelines shall assist the companies in achieving this.

The guidelines include EMA’s recommendations to applicants and holders of marketing authorizations on how best to achieve anonymization and the points to be taken into account in the preparation of redaction of commercially confidential information in clinical reports. Furthermore, the guidelines include an important section on what information EMA does not consider commercially confidential, e.g. information already in the public domain, information not bearing any innovative features and information of public interest.

In general, most data is not considered commercially confidential information and, in case information is commercially confidential, the pharmaceutical company must prepare a justification table in support of the proposed redaction. The guidelines provide detailed guidance on how to complete such a justification table.

Contact one of Delacour’s life sciences specialists, if you would like to know more about the new guidelines.

See the new guidelines here >