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.

If you have comments on a document which is open for consultation, use the Microsoft Office document iconform 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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