EMA publishes Reflection Paper on Off-Label Use for Comment

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The European Medicines Agency (EMA) has published a "Reflection paper on collecting and reporting information on off-label use in pharmacovigilance" for public consultation.

The document contains suggestions about the collection and reporting of information concerning off-label use of medicinal products. In particular, it deals with the collection and reporting of information on off-label use not associated with suspected adverse reactions on the medicinal product.

The following two scenarios can be distinguished:

A. Off-label use of a medicinal product, which results in harm to a patient i.e. the occurrence of one or more suspected adverse reactions

with the obligations of:

• Reporting of individual cases of off-label use associated with suspected adverse reactions (ICSR),
• Periodic reporting of the clinical importance of risks related to the off-label use of a medicinal product (PSUR),
• Risk management planning based on the quantification of off-label use in the context of particular risks and concerns (RMP).

B. Off-label use of a medicinal product, which does not result in harm to a patient i.e. without the occurrence of one or more suspected adverse reactions

with the obligation of:

• Collection and reporting of Information on off-label use, which is brought to the MAH attention and which does not meet the criteria as set out under point A (planned in and based on the RMP)

Comments can be submitted to the EMA until July 29, 2016.

Further information can be found in the draft of the "Reflection paper on collecting and reporting information on off-label use in pharmacovigilance".