Four departments jointly issued a document requiring the strengthening of production and reserve monitoring for essential medicines in short supply and drugs selected in national centralized procurement. Among them, there are 109 essential medicine preparations in short supply, 60 essential medicine active pharmaceutical ingredients (APIs) in short supply, 240 drugs selected in national centralized procurement, and 10 enterprises for essential medicine reserve. The monitoring information submission deadline is the 10th of each month. Enterprises that fail to comply with the requirements will be interviewed and required to make rectifications within a specified timeframe, depending on the circumstances.

On August 9, the Ministry of Industry and Information Technology (MIIT), the National Health Commission (NHC), the National Healthcare Security Administration (NHSA), and the National Medical Products Administration (NMPA) jointly issued the "Notice on Strengthening the Monitoring of Production and Reserves for Essential Medicines in Short Supply and Drugs Selected in National Centralized Procurement." In order to promptly assess the shortage risks of essential medicines in short supply and drugs selected in national centralized procurement, and to enhance the production and supply guarantee capabilities of related drugs, the production and reserve status of the involved enterprises will be included in key monitoring. These enterprises are also required to submit relevant monitoring information online before the 10th of each month.

The monitoring varieties covered include national essential medicines in short supply, nationally monitored essential medicines prone to shortages that are clinically necessary, and varieties selected in national centralized procurement. Both the monitoring variety list and the enterprise list are subject to dynamic adjustment.

As national centralized procurement becomes normalized, for enterprises, stable supply is increasingly valued alongside price requirements. The previous supply interruption incident of Ibuprofen Sustained-Release Capsules by North China Pharmaceutical had a significant impact on the industry and also served as a wake-up call for the formulation of subsequent national centralized procurement rules.

In the recently concluded seventh round of national centralized procurement, an innovative rule involving alternative supply regions appeared for the first time. It is not difficult to see that the purpose is to mitigate the risk of "supply interruptions" that occurred in previous rounds. This document, which includes monitoring the production and reserves of enterprises selected in national centralized procurement, further ensures the smooth progress of the national centralized procurement process.

Regarding ensuring supply and stabilizing prices for essential medicines in short supply, national and local authorities are continuously improving the multi-department collaborative information monitoring mechanism for drugs, enhancing drug supply levels from multiple dimensions, and strengthening the supply and monitoring of key drugs.

On May 27, 2022, the "Recent Work on Ensuring Supply and Stabilizing Prices for Essential Medicines in Short Supply" published on the official website of the National Health Commission stated that tailored and effective solutions would be implemented for drug shortage issues caused by different reasons to ensure basic clinical medication needs. Additionally, it emphasized strengthening regular supervision of drug prices and information feedback, fully mobilizing various resources to address drug shortages and public opinion, and increasing penalties for violations of laws and regulations.

It is believed that with the continuous improvement of the regulatory mechanism, the supply of both national essential medicines in short supply and drugs selected in national centralized procurement will be further guaranteed.

Monitoring Varieties: 109 essential medicine preparations in short supply, 60 essential medicine APIs in short supply, 240 drugs selected in national centralized procurement.

The monitored varieties are those listed in the National Essential Medicines in Short Supply List and the National Key Monitoring List of Essential Medicines Prone to Shortages (clinically necessary) published by the National Health Commission, as well as the drugs selected in national centralized procurement published by the National Healthcare Security Administration. The monitoring variety list is subject to dynamic adjustment.

Monitored Enterprises: 10 Essential Medicine Reserve Enterprises

Monitored enterprises include manufacturers of essential medicines in short supply, enterprises whose drugs are selected in national centralized procurement, and key enterprises for essential medicine reserves (see appendix at the end of the document for details). The monitored enterprise list is subject to dynamic adjustment.

Monitoring Work Mode:

Local industry and information technology authorities, together with health, medical insurance, and drug regulatory authorities, will supervise and guide enterprises within their regions to submit production and reserve information online, and coordinate the organization of production and supply. The MIIT, together with relevant departments, will analyze the production and reserve information, conduct inspections and evaluations as appropriate, publish relevant information, and coordinate the resolution of major issues.

Information Submission Time and Method:

Before the 10th of each month, manufacturers of essential medicines in short supply and manufacturers of drugs selected in centralized procurement must submit the "Pharmaceutical Industry Enterprise Production and Supply Monitoring Report for Essential Medicines in Short Supply" and the "Production and Supply Monitoring Report for National Centralized Procurement Drugs," respectively, through the "Essential Medicine Shortage Production and Supply Monitoring and Early Warning Platform" (website URL). Key enterprises for essential medicine reserves must submit the "Statistical Table of Essential Medicine Inventory Quantities" through the "National Pharmaceutical Reserve Management Information System."

Establish and improve the monitoring information submission work system; no delayed or refused reporting is permitted.

Manufacturers of essential medicines in short supply and drugs selected in centralized procurement are the primary responsible parties for submitting monitoring information on production and reserves. They must establish and improve the monitoring information submission work system; designate specific personnel to submit production and reserve data truthfully, accurately, completely, and promptly; they must not delay or refuse submission; cooperate with relevant departments in investigating drug shortage incidents, providing necessary data for the investigation; set safety stock levels for production supply inventory and prepare contingency plans.

Enterprises that fail to comply with the requirements will be interviewed and required to make rectifications within a specified timeframe, depending on the circumstances.

Strengthen supervision and management. Local industry and information technology authorities, together with relevant departments, are responsible for the production and reserve monitoring of essential medicines in short supply and drugs selected in centralized procurement within their regions. They will organize enterprises to submit relevant data, review the completeness and accuracy of the data, strengthen drug quality supervision and inspection, and urge manufacturers to fulfill their obligations of supplying sufficient quantities according to procurement agreements and reporting production suspensions. Enterprises that fail to comply with the requirements will be interviewed and required to make rectifications within a specified timeframe, depending on the circumstances.