Clinical efficacy and safety: haematology and blood products (including biotech alternatives) guidelines
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
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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
- Clinical investigation of recombinant and human plasma-derived factor IX products
- Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products
- Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products
Reflection papers
Non replacement therapies
Other coagulation factors
- 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
Haematopoietic growth factors
Specific immunoglobulins
- 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
- Core summary of product characteristics for human plasma-derived hepatitis B immunoglobulin for intravenous use
- 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
- Core summary of product characteristics for human varicella immunoglobulin for intramuscular use
Normal immunoglobulins
- Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
- Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)
- Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg)
- Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use
Other
- 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