UK FSA COT Paving the way for a UK Roadmap-Development, Validation and Acceptance of New Approach Methodologies Workshop summary (2021)

Day 1

Last updated: 14 February 2024

Sessions Summary

14.             Professor John Colbourne started the session with “The NAMs Space: Where are we at?” and presented on why this is the right time for NAMs and to look carefully at some opportunities in this space.

15.             Following this presentation the discussion included the European Union (EU) Chemical Strategy (2020), highlighting the priorities and maximising the use of NAMs as well as consideration of the registration, evaluation, authorisation and restriction of chemicals (REACH) by 2022.

16.             It was mentioned that the Environment Protection Agency (EPA) (USA) have made a commitment to ban animal testing by 2035 (EPA, 2019) and awarding $4.25 million to advance the research and development of alternative test methods for evaluating the safety of chemicals that will minimize, and hopefully eliminate, the need for animal testing.

17.             EFSA also support the 3Rs principles (EFSA Alternatives to animal testing) as do the European Medical Agency (EMA) who recently implemented new measures to minimise animal testing during medicines development (EMA, 2019).

18.             Since 2016, there has been an international regulatory government initiative,  Accelerating the Pace of Chemical Risk Assessment (APCRA), whose aim is to promote collaboration and dialogue on the scientific and regulatory needs for the application and acceptance of NAMs in regulatory decision making. Case studies had been initiated following this first workshop; these as well as new case study proposals which are introduced on an ongoing basis.

19.             The other initiatives are:

20.             It was discussed that it would be necessary to read between the lines and gain a clear sense of the time needed to look carefully at how the UK can progress in this space, especially since leaving the EU. The UK can learn from international agencies. The UK Innovation Strategy: leading the future by creating was used to emphasise how this field champions this.

21.              Finally, it was agreed that this workshop is also testimony that change is happening.