What is the collection of raw material drug production and supply information?

On November 3, the Comprehensive Department of the State Drug Administration successively issued the "Notice on Activating the Information Collection Module for Production and Supply of Shortage Drugs and Discontinuation Reports" and the "Notice on Activating the Production and Supply Information Collection Module for APIs", which aroused industry attention
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Both notices will strengthen the supervision of shortage drugs, grasp the production and supply of shortage drugs, and ensure the supply of shortage drugs as the main work goals, and at the same time leave room for future expansion of applications
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For example, the "Notice Regarding the Activation of the Production and Supply Information Collection Module for APIs" mentioned that “in accordance with the needs of drug supervision work, the State Drug Administration will expand the range of APIs collected by this module as appropriate
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At this stage, other varieties Companies can voluntarily fill in and submit information on the production and supply of APIs
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" In the author's opinion, the promulgation of the aforementioned notices and requirements has four major meanings: preventing the risk of drug shortages, strengthening the supervision of raw materials, speeding up the construction of drug supervision informatization, and responding to future changes in the international situation
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Preventing the risk of drug shortages At the end of 2020, 12 departments including the National Health Commission, the National Development and Reform Commission, the National Medical Insurance Administration, and the State Food and Drug Administration jointly issued the "National List of Shortage Drugs" and "The National Key Monitoring List of Clinically Necessary and Easily Shortage Drugs", which were included in total 57 kinds of medicines
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In addition to the national drug shortage list, various provinces (autonomous regions and municipalities) have also issued various shortage drug lists
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As a major drug production country, why is there a shortage of drugs in my country? Insufficient supply of raw materials or excessively high prices of raw materials due to monopoly control of sales, preparation companies have nowhere to purchase or cannot afford high prices, I am afraid it is one of the main reasons
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China is the world's largest producer and exporter of APIs, capable of producing almost all types of APIs.
There are also numerous CRO (Contract Research and Development Organization) and CDMO (Customized R&D and Production) companies that can produce many small batches of APIs
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The shortage of API supply only occurred in the past few years when the stricter environmental protection supervision caused some companies to suspend production and relocate; as the corresponding relocations have been completed one after another, coupled with the implementation of the API registration system in my country and the encouragement of API imports, in recent years The problem of insufficient supply of raw materials has been alleviated
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However, the stubborn disease of the monopoly of APIs has not been completely eliminated
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Since 2017, China has successively investigated and dealt with more than 10 APIs involving methyl salicylate, isoniazid, glacial acetic acid, chlorpheniramine, calcium gluconate, bromhexine hydrochloride, batroxobin, fluocinolone acetate, phenol, etc.
The frequency of investigations and punishments for monopoly cases of various varieties has been accelerated, and the penalties have been increased; and the "Guidelines for the Price Behavior of Short Drugs and Raw Material Drug Operators", "Opinions on Further Doing a Good Job in Maintaining Supply and Stabilizing Prices of Short Drugs", and "Building a High-standard Market System" The Action Plan and the Anti-Monopoly Guidelines of the Anti-Monopoly Committee of the State Council on the Field of APIs and other documents include intensifying the enforcement of violations of API monopoly
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The above-mentioned measures have effectively curbed the development momentum of monopoly of APIs and maintained the order of competition in the API market
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This time, the State Food and Drug Administration issued a notice to collect information on the production and supply of APIs.
On the one hand, it can grasp the production of shortages of APIs from the source, and coordinate with other ministries and commissions to adjust production and supply if necessary; on the other hand, it can also understand the production of APIs.
The number and output of enterprises can provide early warning of the products that may be monopolized, and can also provide evidence for other departments to investigate and deal with the monopoly of APIs
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By regulating production and restraining monopoly, the safety and stability of China's drug supply chain is guaranteed, and the risk of drug shortages is prevented
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Strengthening the supervision and management of APIs According to the "Annual Report on Statistics of Drug Administration (2020)" issued by the State Food and Drug Administration, as of the end of 2020, there are 4460 API and preparation manufacturers in China.
This figure refers to the supervision of the drug supervision system.
The number of pharmaceutical companies that comply with GMP regulations
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In fact, China still has a considerable number of chemical plants that produce APIs and export them in the name of crude products, intermediates or chemicals, squeezing the survival and profit margins of formal GMP enterprises and disrupting the order of China's API export market
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This situation is more obvious during the 2020 new crown pneumonia epidemic.
Some chemical plants export raw materials such as indomethacin and phenolphthalein, and the export prices are about 30% and 60% lower than those of regular raw material drug manufacturers.
The export of medicines caused adverse effects
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However, the production and export activities of chemical companies are not within the scope of daily supervision of the drug regulatory department, and there are certain quality risks.

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Currently, China's API registration and filing system has been implemented for four years, with a total of more than 14,200 records of information and more than 10,800 activated information, with an activation rate of 76%
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Although the registration of APIs has been liberalized, the supervision of APIs is actually more stringent
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The activated API means that it has been used in domestic marketed preparations, and it also means that the production of the API must be subject to GMP inspection at any time
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However, activation does not mean that the company will definitely produce.
The company may also be uneconomical due to rising factor costs.
The weak demand for downstream preparations has reduced the demand for APIs.
The market competition has changed.
Environmental protection, safety, and maintenance have caused production shutdowns.
Adjust the production plan
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How to organically integrate the supervision of APIs with actual production and improve the efficiency of supervision is a focus of scientific supervision and smart supervision in the future
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This time, the State Food and Drug Administration issued a notice to collect information on the production and supply of raw materials, preparing the way for the future to dynamically adjust the GMP inspection and supervision plan according to the production situation of the enterprise
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If the scope of use of the information collection module is expanded to all APIs, the drug regulatory department can conduct appropriate supervision and credit supervision according to the production situation of the enterprise on the one hand, for example, for enterprises with a high GMP inspection pass rate and good credit, the frequency of inspections should be appropriately reduced; on the other hand; It is possible to understand to a certain extent the production of raw materials in chemical plants under non-GMP conditions, and to explore whether to conduct supervision and to what extent
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Accelerating the pace of informatization of drug supervision In recent years, the construction of informatization of drug supervision in China has been continuously deepened and the speed has been accelerating
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The construction of information technology for the supervision of APIs is an important part of it.
The registration system for APIs and the information management system for the export of APIs to the European Union have been online for several years, providing convenience for the government's legal supervision, enterprise application processing, and industry verification and supervision.
, Won wide acclaim
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However, the API industry chain has multiple links such as development, production, sales, use, trade, supervision and management, and the corresponding management authority is scattered in different government departments.

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When different departments exercise management or formulate corresponding policies, there may be inconsistencies and inconsistencies.
For example, customs and inspection and quarantine departments have inconsistent tax classification and identification of the same API, etc.
This is likely to cause conflicts in management.
Enterprises are also at a loss as to what to do
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The Chinese government is accelerating and standardizing the construction of the information system
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In January 2020, the General Office of the State Council issued the "Administrative Measures for the Construction of National Government Information Projects", which stipulated the planning, approval, construction, sharing and supervision of the national government information system, emphasizing the need to adhere to overall planning, co-construction and sharing, and business coordination , The principle of safety and reliability
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This lays the foundation for strengthening data exchange and collaborative management among various government departments
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This time the State Food and Drug Administration issued a notice to collect information on the production and supply of APIs.
If it is expanded to all API products in the future, on the one hand, it can improve the database of the drug supervision system and provide more support for the information construction of API supervision.
On the other hand, it will also help In the next step, the data and information of various ministries and commissions will be networked, and all aspects of the API industry will be managed in an all-round, more direct, precise and effective manner, providing more possibilities
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Responding to future changes in the international situation.
From 2016 to 2017, environmental protection supervision is “one size fits all”, to 2019 Xiangshui explosion case safety supervision is “one size fits all”.
Under the pressure of restriction, there have also been irrational remarks in the industry that the API industry should be transferred overseas
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In this context, the production capacity of some of China's advantageous APIs and intermediates has decreased, and competitiveness has declined, and some have even switched from exports to imports, such as GCLE (cephalosporin intermediates) and prazol intermediates
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The pharmaceutical industry is a strategic safety industry.
The shortage of medical supplies and medicines caused by the new crown pneumonia epidemic sweeping the world has caused a certain degree of tension and anxiety in the international community, and has also aroused the attention of countries to establish an independent and complete medical supply system
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In particular, APIs, like "chips" in the pharmaceutical field, have become an important link related to the safety of the pharmaceutical supply chain
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At present, the international situation is complicated.
To understand the production and operation of important industries and prevent potential market risks is a major issue related to national security
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Since the outbreak of the epidemic, the Chinese government has also begun to pay more attention to the API industry.
The status of APIs in the country has improved, and management policies have gradually shifted from restrictions to support
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However, with the intensive launch of new and expansion projects for domestic APIs, the production capacity of international APIs is facing a new round of expansion, and the industry's overcapacity concerns have reappeared
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This time, the State Food and Drug Administration issued a notice to collect information on the production and supply of APIs.
If it is expanded to all API products in the future, the drug regulatory authorities can understand the production and operation of China's API industry.
On the one hand, it can cooperate with other government departments to produce APIs.
Carry out policy guidance, strengthen policy synergy, prevent overcapacity, reduce the negative impact of low-price auctions, and enhance overall competitiveness; on the other hand, it can analyze the advantages and disadvantages of China's API industry and face the complex international competition situation Under the circumstance, actively make up for the disadvantages, consolidate the advantages, and strive to occupy a favorable position in the future international competition
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(Author's unit: China Chamber of Commerce for Import and Export of Medicines and Health Products)