China’s CDE issued on March 21st, 2022 the guidelines for the listing Adverse reaction in package inserts.


The Adverse Drug Reaction item in the package insert mainly includes the occurrence type, frequency, severity and characteristics and outcome of important Adverse reactions. It is an important source of information to guide the safe and rational use of drugs. This guideline focuses on general considerations for the summary presentation of adverse drug reaction data for anti-tumor compounds and antibodies.

Important principles for adverse reactions in the preparation of the package insert of Antineoplastic Drugs:

  • Ensure comprehensive and accurate collection of safety data.
  • Maintain the relative stability of the presented form.
  • Merger Strategy of Applied Sciences.
  • Timely Update of Cumulative Safety Data.

Important actions described in the Guidelines for Adverse Reactions to Antineoplastic Drugs

  • Guideline describes how to select the most representative number in the frequency calculation of ADRs.
  • How to assess whether to combine or list separately in combination with the characteristics of adverse drug reactions in different situations.
  • How to present adverse reaction data in combination, and considerations for special populations.
  • Important safety guidance significance for clinicians, pharmacists, nurses, and patients.

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