Biologicals: active substance

The European Medicines Agency's scientific guidelines on biological drug substances 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 .

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

Manufacture, characterisation and control of the active substance

Guidelines


Reflection papers


Public statements


Questions and answers

Vaccines

How useful was this page?

Add your rating
Average
1 rating
6 ratings
4 ratings
2 ratings