Monthly Recap: China Pharmaceutical Regulatory Updates | Dec 2021

by Grace Wang Jan 13, 2022

Editor's Notes: Monthly recap is a collection of recently-issued drug laws, regulations and policies in China.

1. China Approves Its First COVID-19 Therapy

On Dec. 8, 2021, Brii Biosciences' Amubarvimab/Romlusevimab Combination received National Medical Products Administration (NMPA)'s approval as the first COVID-19 neutralizing antibody combination therapy in China.

The therapy is approved for treating adults and pediatric patients (aged 12-17, weighing ≥ 40kg) with the mild or normal type of COVID-19 at high risk of progression to severe disease, including hospitalization and death. The indication of pediatric patients is under conditional approval.1

2. China to Decide Whether to Conduct Pre-Approval Inspections Based on Risk Levels

China's Center for Drug Evaluation (CDE) will decide whether to carry out pre-approval inspections based on the risk level of drug registration applications.2

High-risk applications, including new drug applications (NDAs) for innovative/improved new chemical drugs, will be subject to pre-approval inspections if submitted after Jan. 1, 2022. [Read More]

Grace Wang
ChemLinked Regulatory Analyst
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