Companion Diagnostic Definition: EMA

What is a Companion Diagnostic?

A companion diagnostic is a medical device that provides information that is essential for the safe and effective use of a corresponding therapeutic product.

Companion diagnostics are used to identify patients who are most likely to benefit from a particular treatment, and to monitor the effectiveness of treatment.

EMA's Role in Companion Diagnostics

The European Medicines Agency (EMA) is responsible for the regulation of companion diagnostics in the European Union.

EMA's role includes:

• Evaluating the safety and efficacy of companion diagnostics
• Authorizing the marketing of companion diagnostics
• Monitoring the safety of companion diagnostics after they have been marketed

EMA's Guidance on Companion Diagnostics

EMA has published a number of guidance documents on companion diagnostics.

These documents provide guidance on the following topics:

• The development of companion diagnostics
• The evaluation of companion diagnostics
• The authorization of companion diagnostics
• The monitoring of companion diagnostics after they have been marketed

EMA's Role in the Future of Companion Diagnostics

EMA is committed to supporting the development and use of companion diagnostics.

EMA believes that companion diagnostics have the potential to improve the safety and efficacy of medical treatments.

EMA will continue to work with stakeholders to ensure that companion diagnostics are developed, evaluated, authorized, and monitored in a way that protects the health of patients.

Conclusion

Companion diagnostics are an important part of the development and use of medical treatments.

EMA is committed to supporting the development and use of companion diagnostics in a way that protects the health of patients.