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

Reflection papers

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

Points to consider

• Reduction, elimination or substitution of thiomersal in vaccines

Concept papers

• Stability and traceability requirements for vaccine intermediates
• DNA vaccines
• Concept paper on the revision of the COVID-19 vaccines guidance documents

Questions and answers

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

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
• Thiomersal in vaccines for human use - recent evidence supports safety of thiomersal-containing vaccines
• Thiomersal: implementation of the warning statement relating to sensitisation