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

• Clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia - Scientific guideline

Points to consider

• Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells - Scientific guideline

Concept paper

• Need for a guideline on the clinical development of thrombopoetin receptor agonists for the treatment of chronic immune (idiopathic) thrombocytopenic purpura - Scientific guideline