China Adopts ICH E2C (R2): Periodic Benefit-Risk Evaluation Report (PBRER)

In order to strengthen the management of the life cycle of drugs and promote the international integration of drug regulatory technical standards, the National Medical Products Administration (NMPA) has announced on 21 July 2020 that:-

Permit holders submitting regular safety update reports may apply for the ICH “E2C (R2): Periodic Benefit-Risk Evaluation Report (PBRER)” three-level guidelines.

The drug marketing authorization holder can submit a PBRER, or in accordance with national regulations and guidelines.

The Drug Evaluation Center of the NMPA is responsible for related technical guidance, and published the Chinese translated and question-and-answer document of “E2C (R2): Periodic Benefit-Risk Evaluation Report (PBRER)” on the center’s website for the reference of  drug marketing license holders.

Further information to the circular could be accessed here:-


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