Regulation and response to drug shortages in China

Regulator for drug shortages 

According to the current distribution of drug regulations and functions, drug shortage management is scattered among different departments such as the Ministry of Industry and Information Technology, the National Health Commission and the National Medical Products Administration.

The National Medical Products Administration's responsibilities as published on the NMPA's official website state that:

(V) Is responsible for drugs, medical devices and cosmetics post-market risk management. Organize the monitoring, evaluation, and disposal of adverse reactions of drugs, adverse events of medical devices, and cosmetic adverse reactions. Undertake emergency management of drugs, medical devices and cosmetics safety in accordance with the law.

Relevant regulations

In June 2022, in response to the shortage of clobazam, the NMPA and the National Health Commission issued an emergency joint:

--- Temporary Importation of Clinically Necessary Drugs Work Program 

--- Clobazam Temporary Import Work Program 

--- In many documents involving MAHs, it is mentioned that MAHs should draft a shortage drug discontinuation reporting system. 

Action of the Ministry of Industry and Information Technology

Since 2016, the Ministry of Industry and Information Technology has launched batches of shortage drugs designated for production enterprises assessment. 

Actions of provinces 

As of May 2023, Guizhou, Shanxi, Anhui, and Hunan have released their own drug shortage catalogs or management documents.

Reference

NMPA's website