In November 2025, the Czech Republic, Sweden, and the United Kingdom submitted a Standard Project Submission Form (SPSF) to develop a new Reporting Guidance for Biotransformation Systems: Addition to GIVIMP. The project was added to the WNT work plan in April 2026.
First commenting round on the draft Reporting Guidance for Biotransformation Systems: Addition to the Guidance Document on Good In Vitro Method Practice
- Submission period
- 15 October - 24 November 2026
Background public consultation
Project description
The objective of this reporting guidance is to improve the reporting of the addition of biotransformation systems (BTS) to in vitro cell culture methods. A thorough literature review has been conducted by project leads and is now available in the peer-reviewed literature (Lungu-Mitea et al., 2025). Recommendations arising from this review, together with a reporting checklist, have been developed on the basis of the findings of the critical review. Project leads propose to incorporate this guidance into the Guidance Document on Good In Vitro Method Practice (GIVIMP) through additions and amendments to the existing text in Section 5.9, a new subsection under Section 9, “Reporting of results”, and two new annexes. These changes are intended to improve the quality and reproducibility of the use of BTS in both scientific and regulatory reporting of experimental data.
How to contribute
The draft Reporting Guidance for Biotransformation Systems: Addition to GIVIMP is currently under a commenting round by the Working Party of the National Coordinators of the Test Guidelines Programmes and open for comments from the public at the same time. Interested parties are invited to contact their National Coordinators at least a week before 24 November 2026.
