Published: 15.10.2025 · Notice

Reducing animal testing: a phased, three-year approach proposed

For the 7 general chapters withdrawn from the European Pharmacopoeia on 1 January 2026, a phased, three-year discontinuation in the State Pharmacopoeia is proposed, taking local conditions into account.

The Department for the Development of the State Pharmacopoeia of the "Center for Safety of Pharmaceutical Products" state institution is steadily advancing its work to reduce animal testing, discontinue outdated test methods, and replace them with alternative approaches. This direction is consistent with the internationally recognized "Three Rs" concept and aims to progressively reduce the use of live animals in medicines quality control.

A total of 7 general pharmacopoeial chapters are being withdrawn from the European Pharmacopoeia (Ph. Eur.) as of 1 January 2026. The Department held detailed discussions on these chapters and the test methods they set out.

Following these discussions, it was proposed to discontinue the affected test methods in the State Pharmacopoeia not all at once, but gradually — over a period of three years — taking local conditions into account. This approach gives laboratories and manufacturers time to transition to alternative methods and ensures the continuity of the quality-control system.

The "Three Rs" concept

  • Replacement — replacing animal tests with alternative, animal-free methods;
  • Reduction — reducing the number of animals used to obtain the necessary scientific result;
  • Refinement — minimizing the impact on animals by improving test procedures.

The initiative marks an important step toward harmonizing the State Pharmacopoeia with the world's leading pharmacopoeias, modernizing test methods, and aligning them with ethical standards.

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