API will not be issued with approval number separately and will be put on the agenda again

[policies and regulations of pharmaceutical Station] without API, chemical medicine becomes the water without source It is understood that API is the core effective component of chemical products and the core link in the industrial chain, which can be called the "chip" of chemical products Improving the quality of API is very important for the development of pharmaceutical industry API (picture source: pharmaceutical Station) the author learned that on April 4, the State Food and Drug Administration once again publicly solicited opinions on the announcement on further improving matters related to the review, approval and supervision of Drug Association (Draft for comments), further clarifying matters related to the review, approval and supervision of API, pharmaceutical excipients, drug packaging materials and drugs Association This means that APIs will no longer be issued with approval numbers alone According to the opinion draft, for the original auxiliary package that has obtained the approval documents and is continuously used in the preparation before the implementation of the related review and approval policy, the State Drug Administration shall transfer the approval information to the registration platform and give the registration number, with the registration status marked as "a"; The generic API that has been listed in China may not be associated with the drug preparation at the time of registration, i.e it shall be registered separately and reviewed independently After passing the review, the registration status shall be marked with "a" and those failing the review shall be marked with "I" If the API is marked as "a", it means that the API has passed the review and approval, but the approval number of the drug is no longer issued The drug administration of each province (district or city) shall strengthen the supervision and inspection of the pharmaceutical enterprises in its own administrative region, and urge the pharmaceutical enterprises to fulfill the audit responsibility of the suppliers of pharmaceutical excipients and drug packaging materials Administrative license has been cancelled for pharmaceutical auxiliary materials and drug packaging materials, and no fee will be charged for platform registration Insiders generally believe that the API with the original registration number may be directly transferred to DMF for filing when it is renewed, so the pattern of API industry will not change greatly, but the threshold for entering API industry will increase with the improvement of quality requirements In addition, some industry insiders said that although the official documents of DMF have not yet been published, the promotion of the draft for comments believed that the system affecting the change method of key raw materials in the pharmaceutical industry would not let people wait too long With the implementation of the policy, it is urgent to break the monopoly of API It is understood that since 2017, with the country's increasing inspection of environmental protection, vitamin and other API factories have taken the lead, resulting in the forced withdrawal of some small and medium-sized companies from the market and the impact on drug supply According to the price supervision and inspection of the national development and Reform Commission and the information of the Anti-monopoly Bureau, there are 1500 kinds of APIs in China, of which only one enterprise has the approval qualification to produce 50 kinds of APIs, only two enterprises can produce 44 kinds of APIs, and only three enterprises can produce 40 kinds of APIs This will easily lead to the contraction of the supply of APIs and the monopoly of leading enterprises, and the domestic price of vitamin A will gradually strengthen The monopoly of APIs and the joint price rise of enterprises hurt the interests of downstream pharmaceutical manufacturers and patients According to the industry, the combination of the state's strict punishment of monopoly and the liberalization of approval of APIs will truly solve the problem of API monopoly It is understood that in order to curb the monopoly of APIs, the state has been focusing on anti-monopoly investigation in recent years and severely punishing the monopoly price increase For example, at the end of 2018, the State Administration of market supervision and Administration issued a news report showing that three manufacturers of glacial acetic acid API had monopolized and were punished with 12.83 million yuan according to law In recent years, the topic of soaring API prices has emerged in endlessly In 2018, the market price of chlorpheniramine increased 58 times in one month, from 400 yuan / kg to 23300 yuan / kg Phenol, an important raw material of aspirin and other drugs, soared from 230 yuan / kg to 23000 yuan / kg, a 100 fold increase In addition, the prices of inosine, isoniazid, allopurinol tablets and other APIs have been raised to varying degrees As for the monopolized price increase of API, the industry said that to fundamentally solve the problem of API monopoly, we need to change the API audit system We will promote the reform of the approval system for APIs as soon as possible If large pharmaceutical enterprises can produce APIs themselves and the number of API enterprises becomes larger, there will be no monopoly In addition, whether the current punishment has enough deterrent effect on monopoly behavior has also become the focus of discussion in the industry Proposals such as increasing fines and pursuing criminal responsibility for monopoly behavior have been frequently raised.