Update of Guideline on Epidemiological Data

The European Medicines Agency (EMA) has published a concept paper on the revision of the guideline on epidemiological data on blood transmissible infections for comment. The guideline describes the scientific data requirements for the collection, compilation, use and interpretation of epidemiological data for applications for certification, recertification or variation of the Plasma Master File (PMF) to the EMA.

Among other things, the revision of the guideline is intended to provide additional guidance for PMF holders, e.g. on the calculation of residual risk including adjustment factors for hepatitis B virus incidence, adjustments for first-time donors and viraemic window periods. In addition, it is proposed to extend the observation period to more than three years, as longer-term data are now available in the required format.

Further objectives of the revision are the use of control charts or other graphical tools to identify trends in the rates of viral markers in blood establishments or countries and approaches to identify trends at the level of individual collection centres. In addition, the epidemiological data requirements for the accreditation of blood/plasma collection facilities and blood establishments are clarified to facilitate the assessment of epidemiological data of new PMF blood establishments and the appropriate selection of the donor population.

Comments on the concept paper can be submitted until 28 June 2024 via an EU survey form, which can be accessed via the concept paper. Further information and the scientific background of the "Guideline on epidemiological data on blood transmissible infections" are available on the EMA website.