EU Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines (CPMP/SWP/465/95).

Published by The European Agency for the Evaluation of Medicinal Products, EMA

EMAGuidelineVaccineToxicityAnimal ModelsPreclinical Testing

This is a note for guidance  on the preclinical evaluation of new vaccine products including combined vaccines, vaccines are those containing antigens not yet described in European Pharmacopoeia monographs or in WHO requirements and vaccines containing live organisms. It indicated the suitable animal models and ethics issues for vaccine preclinical testing. 

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ICH S8 Guideline 2006. Note For Guidance on Immunotoxicity Studies for Human Pharmaceuticals (Chmp/167235/2004).

Published by European Medicines Agency (EMA)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

EMAGuidelineToxicityAnimal ModelsDrug

This guidance is prepared to provide recommendations on nonclinical testing approaches to identify compounds which have the potential to be immunotoxic, and guidance on a weight-of-evidence decision making approach for immunotoxicity testing. 

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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on Adjuvants in Vaccines for Human Use. 2005 (EMEA/CHMP/VEG/134716/2004).

Published by The European Medicines Agency Evaluation of Medicines for Human Use ,

Animal ModelsNon-Clinical TestingEMAGuidelineVaccineToxicity

This Guideline addresses the quality, non-clinical and clinical issues arising from the use of new or established adjuvants in vaccines. The applicability of this guideline to established adjuvants will vary on a case-by-case basis. 

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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). ICH S5 (R3) Guideline on Reproductive Toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals. Step 5. 17 February 2020. EMA/CHMP/ICH/544278/1998

Published by European Medicines Agency (EMA)

Pharmaceuticals Animal ModelsToxicityClinical TrialsVaccineGuidelineEMA

This guideline applies to all pharmaceuticals, including biopharmaceuticals, vaccines (and their novel constitutive ingredients) for infectious diseases, and novel excipients that are part of the final pharmaceutical product. 

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European Medicines Agency. Committee for Medicinal Products for Human Use. ICH Guideline S11 on Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals. Step 5. 31 March 2020. EMA/CHMP/ICH/616110/2018.

Published by European Medicines Agency (EMA)

Non-Clinical TrialsPharmaceuticals Animal ModelsToxicityGuidelineEMAPaediatrics

This guideline recommends an approach for the nonclinical safety evaluation of pharmaceuticals intended for development in paediatric populations. This can include products with prior adult use, as well as products being considered for initial human use in paediatrics 

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