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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)

Animal Models Clinical Trials EMA Guideline Pharmaceuticals Toxicity Vaccine

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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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

Chemical Substances Chemical Use Directive Ethical Use of Animals Good Laboratory Practice (GLP)

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.

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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

Animal Models EMA Guideline Preclinical Testing Toxicity Vaccine

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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WHO Guidelines on Non-Clinical Evaluation of Vaccines (2005)

Published by WHO Technical Report Series

Guideline Nonclinical Studies Toxicity Vaccine

This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the nonclinical evaluation of vaccines by outlining the international regulatory expectations in this area.

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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

Chemical Substances Chemical Use Directive Ethical Use of Animals Good Laboratory Practice (GLP)

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.

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COMMISSION RECOMMENDATION of 18 June 2007 on Guidelines for the Accommodation and Care of Animals Used for Experimental and Other Scientific Purposes

Published by Official Journal of the European Union

Animal Care Animal Facilities Ethical Use of Animals Guidelines Protection of Animals Recommendation

This directive is to protect animals used for experimental and other scientific purposes to ensure that any possible pain, suffering, distress or lasting harm inflicted as a consequence of procedures being conducted upon them, shall be kept at a minimum. It provides guidelines for the accommodation and care of animals.

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DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the Protection of Animals Used for Scientific Purposes?

Published by Official Journal of the European Union

Directive Ethical Use of Animals Protection of Animals

It is a directive for acknowledged the importance of the protection and welfare of animals used for scientific purposes at international level.

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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)

Animal Models Drug EMA Guideline Toxicity

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 Models EMA Guideline Non-Clinical Testing Toxicity Vaccine

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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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

Directive Ethical Use of Animals Protection of Animals Regulations

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.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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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

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).

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

WHO Guidelines on Non-Clinical Evaluation of Vaccines (2005)

COMMISSION RECOMMENDATION of 18 June 2007 on Guidelines for the Accommodation and Care of Animals Used for Experimental and Other Scientific Purposes

DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the Protection of Animals Used for Scientific Purposes?

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

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).

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