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EU and FDA Advance Reduction of Animal Testing in Drug Development

The challenge is no longer simply finding information. It is knowing where to look, how to navigate it, and how to use it.

The transition towards reducing and ultimately phasing out animal testing in chemical safety assessment is accompanied by a rapidly expanding body of scientific, regulatory and technical knowledge.

Across Europe, information on non-animal methods is available through a growing number of databases, repositories, regulatory websites, scientific publications, guidance documents, training resources, research projects and specialised networks.

Yet an important question remains:

Can people who need this information actually find it, understand it and use it efficiently?

A European Commission report, Analysis of how to facilitate access to information on non-animal methods (Task 4), takes a closer look at this question.

Rather than focusing on the development of new methods, the report examines the information ecosystem that surrounds non-animal methods — what resources already exist, how accessible they are, where important gaps remain, and how access to information could be improved.

The findings point towards a problem that is increasingly important for modern toxicology:

We may not have an information shortage. We may have an information integration problem.


A rich but fragmented information landscape

There is already a considerable amount of information available on non-animal methods.

Researchers, regulators, industry professionals, educators and policymakers can draw on a wide range of resources covering scientific methods, databases, regulatory information, training, funding, research projects, events, case studies and networks.

The European Commission’s analysis considered a broad range of existing resources, including databases and repositories, regulatory information, scientific publications, training and educational resources, funding opportunities, events and networks.

Examples include resources such as RE-Place, the JRC Tracking System for Alternative methods towards Regulatory acceptance (TSAR), the JRC Inventory of 3Rs knowledge sources, AOP-Wiki, the OECD QSAR Toolbox, national 3Rs centres and numerous specialised initiatives.

The issue, therefore, is not that these resources do not exist.

The issue is that they exist across a highly distributed landscape.

A person looking for information may need to move between several websites, databases and documents before being able to assemble a complete picture.

The report highlights this fragmentation and explores how access to existing resources could be made more coherent and user-friendly.


Information is not the same as knowledge

Consider a researcher trying to determine whether a particular non-animal method could be relevant to a specific scientific or regulatory question.

They may need to find out:

  • What does the method measure?
  • What biological process or endpoint does it address?
  • What evidence supports its use?
  • Has the method been developed or validated?
  • Where has it been applied?
  • What is its regulatory status?
  • Is there relevant regulatory guidance?
  • Are there limitations or applicability domains?
  • Are there relevant case studies?
  • Where can training or technical information be found?
  • Who is working with the method?

The answers may already exist.

But they may be distributed across completely different sources.

This creates a fundamental distinction:

Information tells us what exists. Knowledge helps us understand what it means, how the pieces relate to one another, and how the information can be used.

For modern toxicology and regulatory science, that distinction matters enormously.


From repositories to a connected information ecosystem

One of the interesting aspects of the European Commission’s report is that it does not simply point towards creating another database.

Instead, it considers the potential value of a meta-resource capable of connecting users with information that already exists elsewhere.

The concept can be understood as a potential “one-stop shop” for information on non-animal methods — not necessarily a replacement for existing resources, but a way of making the existing landscape easier to navigate.

Such an approach could potentially allow users to search across different types of information and quickly identify relevant resources.

For example, a user could potentially move from a method or topic to:

  • scientific evidence;
  • methodological information;
  • regulatory information;
  • relevant legislation and guidance;
  • development or validation information;
  • databases and software;
  • publications;
  • training opportunities;
  • funding opportunities;
  • case studies;
  • research projects;
  • relevant organisations and networks.

The value would not necessarily come from hosting all of this information in one place.

It could instead come from connecting the places where the information already exists.

That is an important distinction.

The objective would be less about building another silo and more about creating a better map of the existing landscape.


The regulatory dimension

Scientific information is only one part of the equation.

For non-animal methods to contribute meaningfully to chemical safety assessment, users also need to understand the regulatory context in which information and methods may be used.

A method can be scientifically well established but still have limitations regarding a particular regulatory purpose.

Conversely, relevant regulatory information may already exist but be difficult to identify when it is distributed across different regulatory frameworks, organisations and guidance documents.

The European Commission report identifies improved access to regulatory information as one of the areas where the current information landscape could be strengthened.

Resources from organisations such as ECHA and EFSA already provide substantial information, but navigating regulatory information across sectors and legislative frameworks can remain challenging.

This highlights an important interface between:

science → evidence → regulation → decision-making.

Better access to information can therefore support more than scientific discovery.

It can support the translation of scientific knowledge into regulatory practice.


Making information easier to find is only the first step

Searchability is important, but simply making information searchable does not automatically make it useful.

Users also need context.

A long list of methods, publications or databases does not necessarily answer the question that a researcher, regulator or industry professional actually has.

The more useful question may be:

“Which information is relevant to my question, and what should I do with it?”

This is why the report’s discussion of improved filtering, navigation, regulatory overviews, expert contributions, FAQs and other user-oriented features is particularly interesting.

A well-designed information ecosystem could help users move from a broad topic towards the specific evidence and resources that are relevant to their needs.

That is a very different proposition from simply creating a larger catalogue.


Why this matters for toxicology

Toxicology is becoming increasingly interdisciplinary.

Understanding chemical safety can require information from experimental toxicology, exposure science, toxicokinetics, computational modelling, mechanistic biology, molecular biology, epidemiology, environmental science and regulatory frameworks.

The same is true for non-animal methods.

A method cannot always be considered in isolation.

Its usefulness may depend on the biological question, the endpoint, the chemical domain, the available evidence, the regulatory context and how its results can be integrated with other information.

This makes knowledge integration increasingly important.

The challenge is not simply:

“Where is the information?”

It is:

“How do we connect the relevant information so that it becomes meaningful?”


From information access to evidence integration

This is where the discussion becomes particularly relevant to the broader future of toxicology.

The European Commission report provides an opportunity to think beyond individual databases and individual methods.

What if the real objective is not simply to make information available, but to make the information landscape understandable and navigable?

That could mean helping users connect:

methods → evidence → biological mechanisms → regulatory context → practical application

rather than treating each piece of information as an isolated resource.

This does not mean that every resource needs to be merged into a single platform.

In many cases, specialised databases and repositories are valuable precisely because they serve specific purposes.

The challenge is to make these resources more discoverable, more connected and easier to interpret.


A role for better knowledge infrastructure

At Toxicologist, we believe this is an important conversation for the toxicology community.

The future of toxicology will depend not only on generating new scientific evidence, but also on our ability to find, evaluate, connect and communicate the evidence that already exists.

For non-animal methods in particular, the information landscape is already extensive and continues to grow.

The opportunity now is to make that landscape easier to navigate.

That means reducing unnecessary fragmentation.

Improving discoverability.

Connecting scientific and regulatory information.

Making resources easier to compare and interpret.

And designing information systems around the questions that users actually need to answer.

Because ultimately, the value of information is not determined only by whether it exists.

It is determined by whether people can find it, understand it and use it.


Looking ahead

The European Commission’s Task 4 report provides a valuable starting point for thinking about how access to information on non-animal methods could evolve.

Its central message is particularly relevant in an increasingly complex scientific and regulatory environment:

We should make better use of the resources that already exist, improve their accessibility, and create stronger connections between them.

The transition towards reduced reliance on animal testing will require scientific innovation.

But scientific innovation alone is not enough.

It also requires an information infrastructure capable of connecting people with the evidence, methods, guidance and knowledge they need.

The next challenge may therefore not be simply to generate more information.

It may be to build better ways of connecting information into usable knowledge.

From information to evidence.
From evidence to understanding.
From understanding to better decisions.

That is an information ecosystem worth building.


Source

European Commission. Analysis of how to facilitate access to information on non-animal methods (Task 4). Technical assistance for the development of a roadmap towards phasing out animal testing for chemical safety assessments, 2025.

Read the full European Commission report

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