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

About the Author:

zhulikou431

Zhulikou431, as a senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, has deep knowledge in aseptic process development and verification, drug development and registration, CTD document writing and review, regulatory audit, international certification, international registration , quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields. In recent years, he has focused on the analysis of trends in the macro pharmaceutical field and the risk management of pharmaceutical enterprise mergers and acquisitions projects.