The NMPA issued 14 relevant responses

At present, there are few large-scale and long-term drug shortages in China, which are mainly manifested as temporary and local shortages
.
From the perspective of the preliminary work, the shortage of some drugs is mainly related
to the small market demand and the unsmooth supply and demand information.
We strongly agree with your suggestions
on broadening the monitoring channels for drug shortages and improving the strategic reserve of drug shortages.

On broadening the monitoring channels
for drug shortages.
First, the National Health Commission has established a direct reporting system for drug shortage information in public medical institutions nationwide, formed a response and disposal mechanism at the national, provincial, municipal and county levels, established a monthly national drug shortage monitoring system, and notified
the members of the national linkage mechanism and local governments of the monitoring situation.

Second, the Ministry of Industry and Information Technology organized the construction of a monitoring and early warning platform, and continued to dynamically monitor and analyze and warn
the production, sales, inventory quantity and supply of raw and auxiliary materials in real time in 57 countries of key monitoring list varieties of clinically necessary drugs prone to shortage, centralized procurement of drugs in 366 countries, and 90 key class I and class II vaccine specifications.

Third, the National Medical Insurance Bureau focuses on monitoring the prices and supply of the listed varieties on a monthly basis, and comprehensively uses measures such as monitoring and early warning, cost investigation, letter inquiry and interview, credit evaluation, and information disclosure for drugs with abnormal prices or distribution, to strengthen normalized supervision
.

Fourth, the State Food and Drug Administration has developed and constructed an information collection module for the production, supply and suspension of production reports of shortage drugs, and collected the drug production and supply information and the discontinuation report
of shortage drugs in the national shortage drug list and the key monitoring list of drugs that are subject to clinical necessity on a quarterly basis.

On improving the strategic reserve and procurement mechanism
for drugs in short supply.
The Ministry of Industry and Information Technology, together with relevant departments, has successively identified 6 supply guarantee consortiums and built centralized production bases for small-variety drugs, and has now achieved centralized production and stable supply
of 110 small-variety drugs.

In response to the shortage of drugs, organize and guide the establishment of provincial shortage drug reserves
.
The National Medical Insurance Administration allows enterprises to independently quote, directly hang on the network, and independently purchase by medical institutions on the provincial centralized drug procurement platform for the varieties in the national and provincial drug shortage lists; For drugs in the key monitoring list of clinically necessary drugs prone to shortage and the list of shortage drugs, if there are no enterprises on the provincial drug procurement platform or are not included in the centralized procurement directory of the province, medical institutions may put forward procurement needs, search for drug manufacturers offline, negotiate directly with drug supply enterprises, negotiate and determine the purchase price in accordance with the principle of fairness, and independently file on the provincial drug procurement platform to achieve openness and transparency
.

On strengthening anti-monopoly and price supervision
in the field of pharmaceuticals.
The State Administration for Market Regulation (SAMR) continues to strengthen anti-monopoly and price supervision in the pharmaceutical sector and severely cracks down on illegal acts
.

The first is to study and formulate the Anti-monopoly Guidelines in the Field of APIs and improve the rules
of the anti-monopoly system in the field of pharmaceuticals.

The second is to unblock the channels for complaints and reports on the national 12315 platform, pay close attention to relevant price public opinion in the pharmaceutical field, continuously increase the supervision of drug prices for drugs in short supply and drugs with obvious price increases, and regulate and guide the price behavior
of operators in accordance with the law.

Third, in 2021, 2 monopoly cases in the pharmaceutical field will be directly investigated and dealt with, with a fine and confiscation amount of 865 million yuan, which will effectively deter monopolistic behavior
in the pharmaceutical field.

The fourth is to continue to carry out centralized anti-monopoly law enforcement in the pharmaceutical field nationwide in 2021, and guide the market supervision departments of some provinces to successively punish the monopoly behavior of the production and distribution enterprises of four APIs such as fluocinolone acetate, camphor, phenol, and chlorphosphosidine, to ensure the stable supply of relevant APIs at reasonable prices and ensure the production of
downstream preparations.

02 Priority review of medication for children