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Appropriate and reliable laboratory testing of each donation and/or donor, control of reagents,
WP7 pathogen reduction, as well as, where appropriate, post-processing microbiological testing of BTCs,
can substantially reduce the risk of transmission, and improve the overall safety of BTCs. In drafting
the guidance, WP7 leaders have worked with 63 experts from GAPP associated and collaborating
partners, representatives of Competent Authorities, European organizations, Blood and Tissue
Establishments and clinicians.

TECHNICAL ANNEX 3 TO OVERALL GUIDANCE: ASSESSING CLINICAL DATA AS PART OF PPA
WP8 AUTHORISATION
WP Leader: Finnish Medicines Agency (Fimea; Finland), Barcelona Tissue Bank (Spain)

The WP8 group, supported by the valuable collaborations of 46 experts from of 28 organisations,
amongst Associative and collaborative Partners, representatives of Competent Authorities (CA),
clinicians/surgeons, embryologists and tissue bankers, has concluded and submitted to CHAFEA its 3rd
deliverable: “Annex 3. Guidance on how to evaluate plans to collect BTC recipients’ clinical outcome
data upon introduction of innovation to the current BTC processing protocols”.
This guideline establishes a methodological framework required to perform a standardised assessment
of clinical data as part of Preparation Process Authorisation (PPA), and provide CAs with key principles
as to:
- which factors should be considered by CAs when assessing the clinical component of a
Preparation Process Dossier (PPD) for completeness and suitability;
- when a Clinical Follow-up Plan (CFUpP) or a Clinical Investigation Plan (CIP) should be requested
in order to support the authorisation of a new BTC preparation process and/or therapeutic application;
- what elements should be included in the CFUpP or CIP;
- what type of clinical data would be required to determine the safety and efficacy of human
Blood, Tissues, and Cells (BTC) applications for therapeutic use in recipients.
Moreover, WP8 proposes a standard plan for collecting clinical data, proportional to the risk level
(Figure).

The extent of plan for collecting clinical data included in the clinical component of the PPD is based on the risk level.

This brochure is part of the joint action ‘785269/GAPP’ which has received funding from the European Union’s 15
Health Programme (2014-2020) GAPP - Newsletter3