Multidisciplinary: vaccines

The European Medicines Agency's scientific guidelines on vaccines 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

• Adjuvants in vaccines for human use - Scientific guideline
• Clinical evaluation of new vaccines - Scientific guideline
• Development of vaccinia virus-based vaccines against smallpox - Scientific guideline
• Dossier structure and content for pandemic-influenza-vaccine marketing-authorisation application - Scientific guideline
• EMA considerations on COVID-19 vaccine approval - Scientific guideline
• Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines - Scientific guideline
• Influenza vaccines - non-clinical and clinical module - Scientific guideline
• Influenza vaccines - quality module - Scientific guideline
• Influenza vaccines – submission and procedural requirements - Scientific guideline
• Influenza vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context - Scientific guideline
• Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU - Scientific guideline
• Quality aspects included in the product information for vaccines for human use - Scientific guideline
• Preclinical pharmacological and toxicological testing of vaccines - Scientific guideline
• Quality aspects on the isolation of candidate influenza vaccine viruses in cell culture - Scientific guideline
• Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines - Scientific guideline
• Scientific data requirements for a vaccine antigen master file - Scientific guideline
• Testing for simian virus 40 (SV40) in polio virus vaccines - Scientific guideline
• Treatment and prophylaxis of respiratory syncytial virus (RSV) disease - Scientific guideline
• Viral safety of oral poliovirus vaccine (OPV) - Scientific guideline

Reflection papers

• Regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 - Scientific guideline

Points to consider

• Reduction, elimination or substitution of thiomersal in vaccines - Scientific guideline

Concept papers

• Stability and traceability requirements for vaccine intermediates - Scientific guideline
• DNA vaccines

Questions and answers

• Questions and answers on the Haemagglutination Inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations - Scientific guideline
• Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - Scientific guideline

Public statements and position papers

• Evaluation of bovine spongiform encephalopathies (BSE) - risk via the use of materials of bovine origin in or during the manufacture of vaccines - Scientific guideline
• Thiomersal in vaccines for human use - recent evidence supports safety of thiomersal-containing vaccines - Scientific guideline
• Thiomersal: implementation of the warning statement relating to sensitisation - Scientific guideline