Biologicals: active substance

  • Email
  • Help

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 form 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


Specifications

Guidelines


Comparability and biosimilarity

Guidelines


Concept papers


Plasma-derived medicinal products

Guidelines


Reflection papers


Position statements


Plasma master file

Guidelines


Position statements


Vaccines

Guidelines


Points to consider


Public and position statements


Concept papers


Questions and answers


Stability

Guidelines

How useful is this page?

Average rating:

 Based on 5 ratings

Add your rating:

See all ratings
1 ratings
0 ratings
0 ratings
1 ratings
3 ratings

Related content