Clinical investigation of plasma-derived fibrin sealant/haemostatic products - Scientific guideline

This document summarises the clinical trials required for authorisation of new and modified plasma-derived fibrin sealant/haemostatic products.

Keywords: Human fibrinogen, human thrombin, fibrin sealant

Current effective version

Guideline on the clinical investigation of plasma derived fibrin sealant/haemostatic products (CPMP/BPWG/1089/00)

Adopted Reference Number: CPMP/BPWG/1089/00 Legal effective date: 01/01/2005

Document history

Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products and the related core summary of product characteristics

Draft: consultation closed Consultation dates: 01/06/2014 to 31/08/2014 Reference Number: EMA/CHMP/BPWP/572810/2013 Summary:

The currently approved ‘guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products’ came into operation in January 2005. Since then, new fibrin sealant products have been authorised, new methods of application have established and applicants have sought scientific advice on the clinical development of further fibrin sealant / haemostatic products or new indications for approved fibrin sealant products. A revision of the guideline seems appropriate to reflect recent gains in clinical experience.