Overview:
China’s CDE issued on March 21st, 2022 the guidelines for the listing Adverse reaction in package inserts.
INTRODUCTION
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.
NEED HELP WITH NMPA IN CHINA? TALK TO OUR TEAM WE ARE READY TO HELP YOU!
contact china
GRP Whitepaper: Clinical Trial Application in China
In China, a Clinical Trial Application (CTA) should be submitted to the National Medical Products Administration (NMPA), to request the authorization to administer an Investigational Drug to humans
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.