Biologicals: active substance
The European Medicines Agency's scientific guidelines on biological drug substances help medicine developers prepare marketing authorisation applications for human medicines.
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- Manufacture, characterisation and control of the active substance
- Specifications
- Comparability and biosimilarity
- Plasma-derived medicinal products
- Plasma master file
- Vaccines
- Stability
Manufacture, characterisation and control of the active substance
Public statements
Questions and answers
Specifications
Comparability and biosimilarity
Plasma-derived medicinal products
Position statements
Plasma master file
Position statements
Vaccines
Points to consider
Public and position statements