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
Points to consider
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