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

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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.

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

Please submit your comments to the following email address: bpwpsecretariat@ema.europa.eu.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Human coagulation factor VIII & human coagulation factor IX 

Guidelines


Reflection papers

 
Other coagulation factors

Guidelines

 
Normal immunoglobulins

Guidelines

 
Specific immunoglobulins

Guidelines

 
Others

Guidelines

 
General

Guidelines

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