From 3 fixed-point production pilots to 57 information monitoring: the history of changes in drug shortage intervention management

In November 2021, the Comprehensive Department of the State Food and Drug Administration issued a notice stating that the State Food and Drug Administration has developed a module for collecting information on the production, supply and discontinuation reports of drugs in the drug information collection platform, and requires the relevant drug marketing authorization holders to be responsible for reporting the shortage of drugs.

2012 to present: a pilot project for fixed-point production

In 2012, the "Notice of the Ministry of Industry and Information Technology, the Ministry of Health, the National Development and Reform Commission, and the Food and Drug Administration on the Pilot Production of Small-Dosage and Clinically Necessary Essential Drugs" was released

In 2013, the Health and Family Planning Commission, the Ministry of Industry and Information Technology, the National Development and Reform Commission and the Food and Drug Administration formulated the list of the first batch of pilot varieties for the designated production of essential drugs (draft for comments).

However, in 2014, only four varieties were invited for bidding, namely desacetyl lanolin injection (2ml: 0.

The tender result announced in 2015 was desacetyl lanolin injection (2ml: 0.

In 2017, the four departments' notice on the continuation of the pilot program for the first batch of selected varieties of essential medicines for the pilot production of essential drugs mentioned that in the first batch of four designated production pilot varieties, in view of the fact that the number of manufacturers of dobutamine hydrochloride injection has changed.

In 2016, the four ministries and commissions added three new varieties for the pilot production of drugs that are clinically necessary, small in dosage, and short in market supply.

Since 2018, the designated production has been changed from a product pilot to a consortium pilot.

In 2018, the state issued the "Notice on Organizing the Construction of Centralized Production Bases for Small Varieties of Medicines (Drugs in Shortage)" to organize the construction of centralized production bases for small varieties of medicines

In 2019, there are 3 companies in the second batch of centralized production bases for small varieties of drugs (shortage drugs).

2017: Pilot market matching

In 2017, in accordance with the requirements of the "Implementation Opinions on Reforming and Improving the Supply Guarantee Mechanism for Shortage Drugs" (Guowei Yaozhengfa [2017] No.

Among them, Shandong's matchmaking results are as follows:

In 2018, Shandong Province issued the "Shandong Province Short Drug Market Matching Work Plan (Trial)", which was the first to establish a standardized shortage drug market matching mechanism at the provincial level, and a standardized shortage drug market matching mechanism

The first batch in Shandong is bromideamine tablets.

There are 3 products in the second batch, the catalog is as follows:

There are 5 products in the third batch, the catalog is as follows:

Starting in 2019: The drug information sharing mechanism is gradually established

Market matching is one of the main measures to solve the problem of drug shortages, and it is a brand-new method and mechanism

In April 2020, in accordance with the "Notice on Printing and Issuing the National Shortage Drug List Management Measures (Trial)", the provincial linkage mechanism through direct online connection, independent filing and drug storage, etc.

At the end of December of the same year, the Department of Drug Policy and Essential Drug Systems issued the "National List of Shortage Drugs", including the list of shortages (6) and the national key monitoring list of clinically necessary and short-cut drugs (57)

There are 6 national shortage medicine lists, as shown in the following table:

The list of the key monitoring list of national clinically essential and easy-to-shortage drugs is as follows, which includes the 6 products mentioned above on the national shortage drug list, as well as the first batch of fixed-point production of Lobeline, and bromipiz in the catalogue matched by the Shandong market.
Ming and atropine, neostigmine, which was successfully matched across the country, and anti-monopoly penalties for raw materials such as calcium gluconate and allopurinol
.

According to the "Notice of the Comprehensive Department of the State Drug Administration on the Activation of the Information Collection Module for the Production and Supply of Shortage Drugs and Production Suspension Reports", for all products included in the "National List of Shortage Drugs", the holder of the drug marketing authorization is responsible for reporting the production and supply of shortages of drugs.
The production suspension report information shall be submitted online to the provincial drug supervision and administration department where the holder is located; for the products included in the "National Clinical Essential and Easily Shortage Drugs Key Monitoring List", the drug marketing authorization holder is responsible for filling in the production and supply of the easily shortage drugs Information and submit it online to the provincial drug supervision and administration department where the holder is located
.
If the holder is an overseas enterprise, the enterprise legal person designated by the legal person in China shall fill in the report on its behalf, and submit it online to the provincial drug regulatory authority where the enterprise legal person is located
.

summary

The 57 products in the national key monitoring list of clinically necessary and easily shortage drugs basically cover the current shortage of drugs in China
.
There is a policy of speeding up the review and approval of shortage drugs, but there are not many domestically marketed start-up consistency and generic drugs that are declared under the new registration classification
.
If the price of the shortage medicine is reasonable, there should be companies willing to invest in the research and development of the shortage medicine, and companies that have not produced it for a long time are expected to be willing to resume production
.