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Advancing 3Rs in Regulatory Toxicology Project

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Project aim

The aim is to identify opportunities for improving the science behind the regulatory testing of medicines and chemicals through the application of the 3Rs. Among the seven sectors that EPAA is gathering, the ones involved primarily in this project are those concerned with the development of human medicines, veterinary medicines, and crop protection products.

The overriding principle behind the project has been to look at how each sector approaches the issue of regulatory toxicology and to identify opportunities for cross-sector alignment on best practice and on the introduction of new methodologies advancing the 3Rs. Alignment has two aspects: industry alignment on testing methodologies, and regulatory harmonization both across sectors and across global regions. Thus the project aims not only at identifying possibilities but also how these might be translated into regulatory practice

Sectors involved

Pharmaceuticals, Animal Health, Crop Protection

Development and priorities

The Project Team initially conducted a survey of regulatory requirements in the various sectors and then sent a questionnaire to the relevant EPAA member associations (EFPIA, IFAH-Europe and ECPA). This asked for more detailed information on the scope for variation in study design within the existing guidelines, on regional variations in regulatory requirements, on individual company practice, and on the development of alternatives that could advance the 3Rs. The questionnaire was distributed to the member companies of these three organizations and the results collated and analyzed by the Project Team. It was clear that there is considerable divergence in practice within sectors, between sectors and between geographical areas, despite the existence of international harmonization bodies such as ICH and VICH. Moreover, differing practice was as likely to be a result of tradition as a result of the application of science.

Following these discussions, the Project Team selected the area of carcinogenicity testing as one that offered great potential for the project: all sectors need to consider the carcinogenic potential of their products, sector practice is quite divergent, the scientific value of some study designs is currently being questioned and the introduction of in vitro methods offers the possibility of a more targeted and progressive approach to animal testing.

Milestones

28 February 2013 EPAA workshop on carcinogenicity testing: scope for harmonisation and advancing the 3rs (FlashReportpdf)

Next Steps

Ongoing discussions on MTD and Human effects database