GAPP:

Supporting the approval process for blood, tissue, and cell products

 

Timely access to safe drug products is a key issue for clinical medicine. Here the risk-based evaluation of the quality, safety, and effectiveness of these drugs plays a major role. To date the quality, safety, and effectiveness are examined independently of each other since uniform processes for evaluation and approval have not been defined, and because there is no existing aggregation of data on production, approval, and clinical use (effectiveness/complications).

In the joint action project GAPP, 26 organizations in 17 member states of the European Union are working together with the goal of developing a common, optimal approach to the evaluation and approval of production processes for blood, cell, and tissue products according to Article 29 of Directive 2002/98/EC of the European Parliament and of the Council on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and Article 28 of Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

In the long term, GAPP also aims to develop a platform for the exchange of information on the approval of products and production processes between the European Union and the responsible authorities in the member states.



 

The challenge

The project addresses the following challenges:

  • Increasing standardization and improving efficiency in the approval of blood, cell, and tissue products through EU-wide harmonization of the approval and production processes.
  • Developing a concept for an EU-wide data exchange platform to assist approval authorities with the evaluation of new production processes for blood, cell, and tissue products.
  • Establishing an international network of experts to support approval authorities in the evaluation of production processes.
  • Identifying quality criteria, subject to European approval, for the production and inspection processes for blood, cells, and tissue as well as clinical parameters for describing the effectiveness of blood, cell, and tissue products with mapping in an integrated data model.  
     

Our contribution

Fraunhofer ISST as a subcontractor for the Paul Ehrlich Institute is developing the integrated data model incorporating data for production, approval, and clinical use. This is based on international standards. A concept is also being prepared for the data exchange platform, with technical evaluation in a proof of concept using the approval process for a pharmaceutical product made from blood as an example (for instance erythrocyte concentrate). The developed tool helps the manufacturer with filing applications and, through stored guidelines for the application parameters (such as the transport temperature), provides decision support for the approval authority. Linking to clinical use is also planned in order to enable a risk-based evaluation of a pharmaceutical product’s quality and effectiveness based on the aggregated data.

 

Results

The goal is a data exchange platform that makes approved quality criteria available and supports evaluation and decision-making processes on this basis within the framework of approval decisions for blood, cell, and tissue products. The manufacturer is assisted in the electronic application process and the reviewing authority is guided through the entire evaluation process. Supporting information on products and approval decisions collected across Europe is also included in the data exchange platform.

 

Partners

You will find the entire consortium here

The following companies among others are part of the projects:

  • Istituto Superiore di Sanità (ISS – CNT – CNS), Italy (coordinator)
  • Organización Catalana de Trasplantes (OCATT), Spain
  • Agence de la Biomédicine (ABM), France
  • Laakealan Turvallisuus-JA Kehittamiskeskuss (FIMEA), Finland
  • Paul Ehrlich Institute (PEI), Germany

 

Funding

  • Subsidized by: EU Commission (3rd Health Program (2014-2020)
  • Project number:
  • Term: May/2018-04/2021


 

Internet

https://www.gapp-ja.eu/