Biologicals: active substance
The European Medicines Agency's scientific guidelines on biological drug substances help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- ICH Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products - Scientific guideline
- ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products - Scientific guideline
- ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - Scientific guideline
- ICH Considerations: oncolytic viruses - Scientific guideline
- Allergen products: production and quality issues - Scientific guideline
- Development and manufacture of lentiviral vectors - Scientific guideline
- Development, production, characterisation and specifications for monoclonal antibodies and related products - Scientific guideline
- Gene therapy product quality aspects in the production of vectors and genetically modified somatic cells - Scientific guideline
- Human cell-based medicinal products - Scientific guideline
- Potency testing of cell-based immunotherapy medicinal products for the treatment of cancer - Scientific guideline
- Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission - Scientific guideline
- Production and quality control of animal immunoglobins and immunosera for human use - Scientific guideline
- Production and quality control of medicinal products derived by recombinant DNA technology - Scientific guideline
- Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Scientific guideline
- Quality of biological active substances produced by stable transgene expression in higher plants - Scientific guideline
- Quality of biological active substances produced by transgene expression in animals - Scientific guideline
- Quality, preclinical and clinical aspects of gene therapy medicinal products - Scientific guideline
- Use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products - Scientific guideline
- Xenogeneic cell-based medicinal products - Scientific guideline
- Design modifications of gene therapy medicinal products during development - Scientific guideline
- In-vitro cultured chondrocyte containing products for cartilage repair of the knee - Scientific guideline
- Quality, non-clinical and clinical issues relating specifically to recombinant adeno-associated viral vectors - Scientific guideline
- Stem cell-based medicinal products - Scientific guideline
Public statements
- DNA and host cell protein impurities, routine testing versus validation studies - Scientific guideline
- Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products - Scientific guideline
Questions and answers
- ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products - Scientific guideline
- Similar biological medicinal products - Scientific guideline
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues - Scientific guideline
- Investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk - Scientific guideline
- Plasma-derived medicinal products - Scientific guideline
- Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products - Scientific guideline
Position statements
- Requirements for plasma master file certification - Scientific guideline
- Scientific data requirements for plasma master file - Scientific guideline
- Epidemiological data on blood transmissible infections - Scientific guideline
- Validation of immunoassay for the detection of antibody to human immunodeficiency virus in plasma pools - Scientific guideline
- Validation of immunoassay for the detection of hepatitis B virus surface antigen in plasma pools - Scientific guideline
Position statements
- Quality and safety assessment for the plasma master file (PMF) certification with regard to donor deferral criteria for sexual risk behaviour - Scientific guideline
- Non-remunerated and remunerated donors: safety and supply of plasma-derived medicinal products - Scientific guideline
Questions and answers
- Adjuvants in vaccines for human use - Scientific guideline
- Development of vaccinia virus-based vaccines against smallpox - Scientific guideline
- Influenza vaccines - quality module - Scientific guideline
- Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines - Scientific guideline
- Requirements for vaccine antigen master file certification - Scientific guideline
- Scientific data requirements for a vaccine antigen master file - Scientific guideline
Points to consider
Public and position statements
- Evaluation of bovine spongiform encephalopathy risk via the use of materials of bovine origin in or during the manufacture of vaccines - Scientific guideline
- Quality of water used in the production of vaccines for parenteral use - Scientific guideline
- Testing for simian virus 40 (SV40) in polio virus vaccines - Scientific guideline
- Viral safety of oral poliovirus vaccine (OPV) - Scientific guideline