English
Release Date: March 31, 2026
Source: European Medicines Agency (EMA)
The European Medicines Agency (EMA) has launched a public consultation on a new methodology that could significantly reduce animal use in preclinical research.
The proposal introduces virtual control groups, a novel approach that replaces traditional animal control groups in certain toxicity studies.
What Are Virtual Control Groups?
Virtual control groups are created using historical control data combined with statistical modeling and expert evaluation. Instead of using live animals as control subjects, researchers identify “virtual comparator animals” to assess treatment effects.
This method is part of a broader class of New Approach Methodologies (NAMs) designed to improve research efficiency and reduce reliance on animal testing.
A Step Toward Reducing Animal Use
The draft qualification opinion, issued by EMA’s Committee for Medicinal Products for Human Use (CHMP), represents an important step toward implementing the 3Rs principles:
Replace animal use where possible
Reduce the number of animals required
Refine experimental methods
While the impact will be gradual, this approach could significantly reduce the number of animals used in dose-range finding and toxicology studies over time.
Regulatory and Scientific Impact
If qualified, virtual control groups may be accepted as scientifically valid evidence in future medicine applications within a defined context of use.
Key potential benefits include:
Reduced reliance on animal testing
Improved efficiency in non-clinical studies
Enhanced consistency through standardized data models
However, EMA emphasizes that:
Study integrity must not be compromised
Human safety in later clinical trials must remain fully protected
Public Consultation Open
EMA is inviting feedback from stakeholders and the scientific community.
Consultation period: March 31 – May 12, 2026
Feedback can be submitted via EMA’s official channels
Advancing Ethical and Innovative Drug Development
The adoption of virtual control groups aligns with broader international efforts, including those supported by global regulatory collaborations, to promote alternative testing strategies.
By integrating NAMs, EMA aims to:
Encourage innovation in drug development
Improve predictive value of preclinical studies
Support more ethical research practices
Conclusion
EMA’s consultation on virtual control groups marks a significant step toward reducing animal testing in medicines development. As regulatory frameworks evolve, such innovative methodologies are expected to play an increasingly important role in shaping the future of preclinical research.
The FAI climbed 5.9 percent year-on-year in the first 11 months of 2018, quickening from the 5.7-percent growth in Jan-Oct, the National Bureau of Statistics (NBS) said Friday in an online statement.
The key indicator of investment, dubbed a major growth driver, hit the bottom in August and has since started to rebound steadily.
In the face of emerging economic challenges home and abroad, China has stepped up efforts to stabilize investment, in particular rolling out measures to motivate private investors and channel funds into infrastructure.
Friday's data showed private investment, accounting for more than 60 percent of the total FAI, expanded by a brisk 8.7 percent.
NBS spokesperson Mao Shengyong said funds into weak economic links registered rapid increases as investment in environmental protection and agriculture jumped 42 percent and 12.5 percent respectively, much faster than the average.
In breakdown, investment in high-tech and equipment manufacturing remained vigorous with 16.1-percent and 11.6-percent increases respectively in the first 11 months. Infrastructure investment gained 3.7 percent, staying flat. Investment in property development rose 9.7 percent, also unchanged.