Epidemiological data on blood transmissible infections - Scientific guideline

This revised guideline uses the terms blood establishment and centres, i.e. the term 'organisation' has been replaced with 'blood establishments' to be consistent with the Guideline on the scientific data requirements for a plasma master file (PMF) - Revision 1

Keywords: PMF, epidemiology, first time tested donors, repeat tested donors, prevalence, incidence, residual risk, risk estimate, control charts, trends

Current effective version (under revision, see document history)

Guideline on epidemiological data on blood transmissible infections - Revision 1

Adopted Reference Number: EMA/CHMP/BWP/548524/2008 Rev.1 Legal effective date: 30/08/2016

Appendices to guideline on epidemiological data on blood transmissible infections - Revision 1

Reference Number: EMA/735037/2015 Rev.1

Document history - Revision 2

Guideline on epidemiological data on blood transmissible infections - Revision 2

Adopted Reference Number: EMA/CHMP/BWP/548524/2008 Rev.2 Legal effective date: 30/07/2026

Appendices to guideline on epidemiological data on blood transmissible infections - Revision 2

Reference Number: EMA/735037/2015 Rev. 2

Overview of comments received on chapter 9 of guideline on epidemiological data on blood transmissible infections

Reference Number: EMA/CHMP/BWP/548524/2008 Rev.2

Draft chapter 9 of guideline on epidemiological data on blood transmissible infections

Draft: consultation closed Consultation dates: 18/06/2025 to 31/08/2025 Reference Number: EMA/CHMP/BWP/548524/2008 rev 2 Summary:

This revision is only revising chapter 9 of the full guideline: Guideline for epidemiological data on blood transmissible infections. Upon finalisation the chapter 9 will be merged in the full guideline.

Concept paper on the revision of the 'Guideline on epidemiological data on blood transmissible infections' - Revision 2

Draft: consultation closed Consultation dates: 30/04/2024 to 28/06/2024 Reference Number: EMA/CHMP/BWP/4/2024 Summary:

The guideline on epidemiological data on blood transmissible infections (EMA/CHMP/BWP/548524/2008 rev 1) outlines the scientific data requirements for epidemiological data on blood transmissible infections to be included in applications for Plasma Master File (PMF) certification or annual recertification submitted to the EMA.

The guideline requires that a system of alert limits for epidemiological data should be in place to identify individual blood/plasma collection centres with viral infections rates outside the normal range for the given donor population in the PMF (outliers) and to be able to take appropriate corrective actions, if needed. This is an essential part of the measures taken to ensure that donations do not come from donors with a high risk of being infected with blood transmissible agents.

In 2022, as part of a Q&A for PMF holders (PMF-Hs) (EMA/CHMP/BWP/721411/2022) additional guidance encouraged the usage of parametric models for establishing alert limits although clarified that non parametric models might be acceptable, if sufficiently justified.

In 2023, in view of the experience gathered during the review of the alert limits information in recent PMF annual updates (AU) and the requests from the plasma fractionation industry for further guidance, the need to expand the information for PMF holders on the approach and the statistical method for the appropriate calculation of alert limits was identified. The revision and expansion on the alert limit calculations of the epidemiological guideline is proposed as part of the 3-year BWP workplan 2024-2026.

Document history - Revision 1

Guideline on epidemiological data on blood transmissible infections - Revision 1

Adopted Reference Number: EMA/CHMP/BWP/548524/2008 Rev.1 Legal effective date: 30/08/2016

Appendices to guideline on epidemiological data on blood transmissible infections - Revision 1

Reference Number: EMA/735037/2015 Rev.1

Overview of comments received on Draft Revision of the Guideline on epidemiological data on blood transmissible infections (EMA/CHMP/BWP/548524/2008)

Reference Number: EMA/651460/2015

Draft guideline on epidemiological data on blood transmissible infections

Draft: consultation closed Consultation dates: 01/06/2015 to 31/08/2015 Reference Number: EMA/CHMP/BWP/548524/2008 Summary:

This guideline outlines the scientific data requirements for epidemiological data on blood transmissible infections to be included in applications for Plasma Master File certification submitted to the European Medicines Agency (EMA). It is a new revision of the CHMP/EMA Plasma Master File epidemiology guideline (EMEA/CPMP/BWP/125/04) which came into operation in July 2005.

Concept paper on revision of guideline on epidemiological data on blood-transmissible infections

Draft: consultation closed Consultation dates: 01/08/2014 to 31/12/2014 Reference Number: EMA/CHMP/BWP/295676/2014 Summary:

The guideline on epidemiological data on blood-transmissible infections (EMA/CHMP/BWP/548524/2008) outlines the scientific data requirements for epidemiological data on blood-transmissible infections to be included in applications for plasma-master-file certification submitted to the European Medicines Agency. The first revision of this guideline came into effect in 2011, and it was recognised at that time that a further revision may be needed based on the experience of data submission and evaluation.

Document history - Second version

Guideline on epidemiological data on blood transmissible infections

Adopted Reference Number: EMA/CHMP/BWP/548524/2008 Legal effective date: 01/03/2011 Summary:

This guideline outlines the scientific data requirements for epidemiological data on blood transmissible infections to be included in applications for Plasma Master File certification submitted to the EMA. It represents a revision of the CHMP/EMA Plasma Master File epidemiology guideline which came into operation in July 2005.

Appendices to guideline on epidemiological data on blood transmissible infections

Reference Number: EMA/CHMP/BWP/174129/2009

Overview of comments received on draft guideline on epidemiological data on blood transmissible infections

Reference Number: EMA/CHMP/BWP/711072/2009 Legal effective date: 01/03/2011

Draft revision on the guideline on epidemiological data on blood transmissible infections (EMEA/CPMP/BWP/125/04. rev 1)

Draft: consultation closed Reference Number: EMEA/CPMP/BWP/125/04. Rev 1

Concept paper on the revision of the guideline on epidemiological data on blood transmissible infections (EMEA/CPMP/BWP/125/04)

Reference Number: EMEA/CHMP/BWP/505885/2008

Document history - First version

Guideline on epidemiological data on blood transmissible infections - For inclusion in the Guideline on the Scientific data requirements for a Plasma Master File (EMEA/CPMP/BWP/3794/03)

Adopted Reference Number: EMEA/CPMP/BWP/125/04 Legal effective date: 31/07/2005