EU CPMP Note On Expert Reports

The European Commission Committee for Proprietary Medicinal Products has this month published an explanatory note on the Expert Report, noting that many applications, particularly for new active substances, have been including a written summary as well as the tabulations to the Expert Reports.

Each Expert Report should contain a critical discussion of the product's properties. This means three Reports, covering quality (normally less than 10 pages), safety and efficacy (normally less than 25 pages each). The expert should take and defend a clear position on the product in the light of current scientific knowledge. Each expert report should be followed by tabular formats, as set out in the Notice to Applicants of January 1989, which provided a standardized approach to presentation of the documentation in tabular form.

The written summary should be factual, complete and concise, containing cross-references to the documentation in the relevant part of the dossier as well as tables, graphs, etc. The CPMP stresses the need to avoid duplication and repetition between the Expert Report and the written summary, but adds that equally, a good tabular presentation with a short written summary is effective. Therefore, where tabular formats suffice, it is not necessary to duplicate the message in writing.