Biologicals: finished product
The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Declaration of the quantitative composition/potency labelling of biological medicinalproducts that contain modified proteins as active substance - Scientific guideline
- Description of composition of pegylated (conjugated) proteins in the summary of product characteristics - Scientific guideline
- Quality aspects included in the product information for vaccines for human use - Scientific guideline
- Potency labelling for insulin analogue containing products with particular reference to the use of "international units" or "units" - Scientific guideline
- Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline
- Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline
Points to consider for assessors
Concept papers
Guidelines
- Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics) - Scientific guideline
- Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need - Scientific guideline
Guidelines
- ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline
- Adventitious agent safety of urine-derived medicinal products - Scientific guideline
- Use of bovine serum in the manufacture of human biological medicinal products - Scientific guideline
- Use of porcine trypsin used in the manufacture of human biological medicinal products - Scientific guideline
- Virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses - Scientific guideline
Position papers and statements
Guidelines
- Investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk - Scientific guideline
- Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products - Scientific guideline
Questions and answers
Position papers, public statements and reports
- Creutzfeldt-Jakob disease and advanced therapy medicinal products - Scientific guideline
- Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Scientific guideline
- Evaluation of bovine spongiform encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines - Scientific guideline
- First cases of BSE in USA and Canada: risk assessment of ruminant materials originating from USA and Canada - Scientific guideline
- Polysorbate 80 - Scientific guideline
- Production of tallow derivatives for use in pharmaceuticals - Scientific guideline
- Re-establishment of working seeds and working cell banks using TSE compliant materials - Scientific guideline
- Risk and regulatory assessment of lactose and other products prepared using calf rennet - Scientific guideline