Page 2 - NewsletterVol2
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GAPP Join Action
Background
Since the directives 2002/98/EC, 2004/23/
EC, 2005/61/EC, 2006/86/EC were adopted in
Europe, significant technical developments have
taken place and the complexity of preparation
processes of blood, tissues and cells, has greatly
increased. Goals
A variety of process steps has been modified or
introduced into routine use and new resulting GAPP Joint Action is an ongoing 36 month EU
products are being used in the patients. project which addresses the authorisation of
preparation processes in blood and tissues
Increasing complexity of processing can and cells aiming at:
bring significant quality and functionality
improvements of the products for patients’ Increasing consistency and efficacy of
treatment, and/or more efficient use of Competent Authority (CA) regulatory 01
donations, but it may also bring increased risk, activities through harmonisation of EU-
particularly as the level of complexity brings level tools for authorisation procedures for
the final product towards the borderline with preparation processes at Blood and Tissues
medicinal products. Establishments,
Developing a concept model for a European
The assessment and control of risks should knowledge-sharing platform that can support 02
be ensured via the preparation process CAs in the assessment and evaluation of
authorisation procedures in place in each novel preparation processes of products,
Member State. and
Establishing an international network of
specifically trained assessors / inspectors 03
that can support CAs in the assessment
and evaluation of preparation processes of
products.
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