ECHA has published new IUCLID (International Uniform Chemical Information Database) pharmaceutical datasets for 348 approved pharmaceuticals that support alternatives to animal testing. The new datasets provide sturdy information about the pharmaceuticals in a structured format for the industry as well as research. These datasets aim to reduce the testing on animals. This alternative method supports toxicity assessment of structurally similar chemicals intending to reduce the need for animal testing.

They can also be used to develop predictive models and to analyze correlations based on animal and human data. Users can assess the relevance of animal models to humans by comparing the results of animal tests with their effects on humans.

The datasets have been prepared by extracting animal and human data from files that was provided by the United States’ Food and Drug Administration. This also includes the studies about the carcinogenicity as well as repeat-dose, developmental and reproductive toxicity. They also have the information about the effect of medicines on human that was taken from the standard product labels of approved drugs.

In the later part of 2023, a total of 530 datasheets will be available. In addition, scientific paper will also be published to explain their development and architecture.


Reach out to our regulation experts on product regulatory compliances