Clinical efficacy and safety: blood products (including biotech alternatives)

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.

Guidelines

• Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use - Scientific guideline
• Clinical investigation of hepatitis B immunoglobulins - Scientific guideline
• Core summary of products characteristics for human anti-D immunoglobulin for intramuscular use - Scientific guideline
• Core summary of product characteristics for human anti-D immunoglobulin for intravenous use - Scientific guideline
• 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 - Scientific guideline
• Core summary of product characteristics for human tetanus immunoglobulin for intramuscular use - Scientific guideline
• 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 - Scientific guideline

Guidelines

• Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Scientific guideline
• 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

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

• Immune tolerance induction in haemophilia A patients with inhibitors - Scientific guideline

Guidelines

• Clinical investigation of human plasma-derived von Willebrand factor products - Scientific guideline
• Core summary of product characteristics for human fibrinogen products - Scientific guideline
• Core summary of product characteristics for human plasma coagulation factor VII products - Scientific guideline
• Core summary of product characteristics for human plasma derived von Willebrand factor - Scientific guideline
• Core summary of product characteristics for human prothrombin complex products - Scientific guideline

Guidelines

• Clinical investigation of plasma-derived antithrombin products - Scientific guideline
• Clinical investigation of plasma-derived fibrin sealant/haemostatic products - Scientific guideline
• Core summary for product characteristics for human albumin solution - Scientific guideline
• Core summary of product characteristics for human plasma derived antithrombin - Scientific guideline
• Core summary of product characteristics for plasma-derived fibrin sealant/haemostatic products - Scientific guideline

Guidelines

• Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline