ANIMPACT – An Ethical, Legal and Practical Perspective on the Impact of a New Regulatory Framework for the Scientific Use of Animals on Research and Innovation. Final Publishable Summary Report. 1.OCT.2013 – 31.Dec.2016

Published by CORDIS EU Research Results

Ethical Use of AnimalsDirectiveProtection of AnimalsRegulations

The project ANIMPACT – An ethical, legal and practical perspective on the impact of a new regulatory framework for the scientific use of animals on research and innovation have addressed external and internal regulation mechanisms regulating animal research in Europe. 

View this resource Bookmark this resource

DIRECTIVE 2004/9/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on the Inspection and Verification of Good Laboratory Practice (GLP).

Published by Official Journal of the European Union

Ethical Use of AnimalsDirectiveGood Laboratory Practice (GLP)Chemical UseChemical Substances

This Directive is to verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals in order to assess the effect of such products on man, animals and the environment. 

View this resource Bookmark this resource

DIRECTIVE 2004/10/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004  on the Harmonisation of Laws, Regulations and Administrative Provisions Relating to the Application of the Principles of Good Laboratory Practice and the Verification of Their Applications for Tests on Chemical Substances (Codified Version) 

Published by Official Journal of the European Union

Ethical Use of AnimalsDirectiveGood Laboratory Practice (GLP)Chemical UseChemical Substances

This directive indicates harmonisation of laws, regulations and administrative provisions relating to the application of principles of good laboratory practice and the verification of their applications for tests on chemical substances. 

View this resource Bookmark this resource

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. 

View this resource Bookmark this resource

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. 

View this resource Bookmark this resource

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. 

View this resource Bookmark this resource

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)

ToxicityAnimal ModelsPharmaceuticals EMAGuidelineVaccineClinical Trials

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. 

View this resource Bookmark this resource

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)

ToxicityAnimal ModelsPharmaceuticals Non-Clinical TrialsPaediatricsEMAGuideline

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 

View this resource Bookmark this resource