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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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 ,

EMAGuidelineVaccineToxicityAnimal ModelsNon-Clinical Testing

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). Guideline on the Need for Non-Clinical Testing in Juvenile Animals of Pharmaceuticals for Paediatric Indications. 2008 (EMEA/CHMP/SWP/169215/2005).

Published by European Medicines Agency (EMA)

Juvanile AnimalsPaediatric IndicationsEMAGuidelineAnimal ModelsNon-Clinical Testing

This document provides guidance on the need for, role and timing of studies in juvenile animals in the non-clinical safety evaluation of medicinal products for paediatric use. It is applicable to initial medicinal products applications and also to authorised medicinal products being further developed to include paediatric indications. It outlines potential safety concerns that cannot be adequately assessed in the adult population, in standard non-clinical studies, or in clinical trials. 

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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)

PaediatricsNon-Clinical TrialsPharmaceuticals Animal ModelsToxicityGuidelineEMA

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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