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.

Product information

Guidelines

• Declaration of the quantitativecomposition/potency labelling of biological medicinal products that contain modified proteins as active substance
• Description of composition of pegylated (conjugated) proteins in the summary of product characteristics
• Quality aspects included in the product information for vaccines for human use
• Potency labelling for insulin analogue containing products with particular reference to the use of 'international units' or 'units'
• Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products

Points to consider for assessors

• Points to consider for assessors - New factor VIII and factor IX products: potency determination for labelling and assays for testing post-infusion samples

Concept papers

• Potency declaration/labelling for biological medicinal products which contain modified proteins as active substance

Pharmaceutical development

Guidelines

• Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics)
• 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

Adventitious agents safety evaluation

Guidelines

• ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
• Adventitious agent safety of urine-derived medicinal products
• Use of bovine serum in the manufacture of human biological medicinal products
• Use of porcine trypsin used in the manufacture of human biological medicinal products
• Virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses

Position papers and statements

• Testing for simian virus 40 (SV40) in polio virus vaccines
• Viral safety of oral poliovirus vaccine (OPV)

Transmissible spongiform encephalopathies (TSEs) (animal and human)

Guidelines

• Investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk
• Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products

Questions and answers

• Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines

Position papers, public statements and reports

• Creutzfeldt-Jakob disease and advanced therapy medicinal products
• Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products
• Evaluation of bovine spongiform encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines
• First cases of BSE in USA and Canada: risk assessment of ruminant materials originating from USA and Canada
• Polysorbate 80
• Production of tallow derivatives for use in pharmaceuticals
• Re-establishment of working seeds and working cell banks using TSE compliant materials
• Risk and regulatory assessment of lactose and other products prepared using calf rennet

Investigational medicinal products

Guidelines

• Requirements for quality documentation concerning biological investigational medicinal products in clinical trials
• Virus safety evaluation of biotechnological investigational medicinal products

Genetically modified organisms (GMOs)

Guidelines

• Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOs)
• Scientific requirements for the environmental risk assessment of gene-therapy medicinal products

Specifications

Guidelines

• ICH Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products

Lifecycle management

Guidelines

• ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management