The European Medicines Agency's scientific guidelines on the clinical evaluation of blood products help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Haemophilia
Human coagulation factor VIII & human coagulation factor IX
Guidelines
- Clinical investigation of recombinant and human plasma-derived factor VIII products-Scientific guideline
- Clinical investigation of recombinant and human plasma-derived factor IX products- Scientific guideline
- Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products - Scientific guideline
- Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Scientific guideline
Reflection papers
Non replacement therapies
Other coagulation factors
Guidelines
- Clinical investigation of human plasma-derived von Willebrand factor products
- Core summary of product characteristics for human fibrinogen products
- Core summary of product characteristics for human plasma coagulation factor VII products
- Core summary of product characteristics for human plasma derived von Willebrand factor
- Core summary of product characteristics for human prothrombin complex products
Chronic primary immune thrombocytopenia
Guidelines
Reflection papers
Haematopoietic growth factors
Specific immunoglobulins
Guidelines
- Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use
- Clinical investigation of hepatitis B immunoglobulins
- Core summary of products characteristics for human anti-D immunoglobulin for intramuscular use
- Core summary of product characteristics for human anti-D immunoglobulin for intravenous use
- Core summary of product characteristics for human plasma-derived hepatitis B immunoglobulin for intramuscular use - Scientific guideline
- Core summary of product characteristics for human plasma-derived hepatitis B immunoglobulin for intravenous use - Scientific guideline
- Core summary for product characteristics for human rabies immunoglobulin for intramuscular use
- Core summary of product characteristics for human tetanus immunoglobulin for intramuscular use
- Core summary of product characteristics for human tick-borne encephalitis immunoglobulin for intramuscular use - Scientific guideline
- Core summary of product characteristics for human varicella immunoglobulin for intramuscular use
Normal immunoglobulins
Guidelines
- Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
- Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline
- Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) - Scientific guideline
- Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use - Scientific guideline
Other
Guidelines
- Clinical investigation of plasma-derived antithrombin products
- Clinical investigation of plasma-derived fibrin sealant/haemostatic products
- Core summary for product characteristics for human albumin solution
- Core summary of product characteristics for human plasma derived antithrombin
- Core summary of product characteristics for plasma-derived fibrin sealant/haemostatic products
Clinical efficacy and safety: blood and blood-forming organs
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the blood and blood-forming organs help medicine developers prepare marketing authorisation applications.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
Points to consider
Concept paper