COPYRIGHT© Jilin Zixin Pharmaceutical Industrial Co.,Ltd.

COPYRIGHT© 2018  吉林紫鑫药业股份有限公司

2017's most influential seven major medical policies

Page view

Medical insurance network, centralized procurement, drug review and approval, development planning, clinical management, flight inspection, "two-vote system", grading diagnosis and treatment, drug and service price reform, and consistency evaluation are ten tasks that are more concentrated in the 2017 release documents. These jobs will continue in 2018. To this end, the author summarizes and interprets the seven policies that have the most far-reaching impact on the industry since 2017, in order to readers.


1. "Two Offices 36"

On October 1, the General Office of the CPC Central Committee and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices" and proposed 36 important reform measures (referred to as "two offices and 36 articles"). This is the document issued by the highest government agency.


The policy is clear: to promote new drug innovation, promote the development of generic drugs, and re-evaluate research on listed injections and devices. This policy is beneficial to the development of rare disease drugs, child-specific drugs, innovative therapeutic biological products, biosimilar drugs, and clinically valuable pharmaceutical and medical products. The approval of the drug number, injection and medical device re-evaluation policy will no longer cause the market change of the relevant listed products.

Key points


◎ Innovate clinical trial management, speed up the approval of listing review, promote the development of pharmaceutical innovation and generic drugs, strengthen the life cycle management of pharmaceutical medical devices, enhance technical support capabilities, and strengthen organizational implementation to encourage innovation in pharmaceutical medical devices.


◎ Special attention should be paid to the re-evaluation of injections, the prohibition of drug sales by pharmaceutical representatives, the strict control of oral preparations for injections, the publication of rare disease catalogues, the delay in listing due to clinical trials and review and approval, and the granting of appropriate patent period compensation and other heavyweight policies. 



Understanding the implementation rules and the right analysis of the impact on the pharmaceutical industry is key.


On the one hand, it simplifies the administrative examination and approval of new medical device products in clinical trials and registration management; on the other hand, it strengthens the verification of test data and the approval of injections and the responsibility of listed licensors.


On the one hand, it speeds up the approval of new drug devices, including special approvals for rare diseases and clinical development applications, strengthens clinical data protection and the use of foreign data to encourage new product development; on the other hand, through the Orange Book and patent links and compulsory licenses, Encourage the listing of generic drugs.


The policy is mainly based on R&D and innovation. It also mentions the circulation and promotion of drugs. The core content is consistent with the No. 13 document promulgated by the State Council.


The positive value of the medical representatives is recognized, and the filing and supervision are further strengthened. The medical representative filing system and the two-vote system will inevitably be implemented. It must be noted that the identification of a drug in the name of an individual is clearly defined as “the crime of illegal business”.


2. Drug Administration Law

On October 23, CFDA publicly solicited opinions on the "Amendment of the Drug Administration Law of the People's Republic of China (Draft for Soliciting Opinions)".


The drug management law is highly valued because it is the only big law in the pharmaceutical industry. It is a big law that needs to be voted through the NPC. Other pharmaceutical industry laws are only departmental laws.


This time it is only a partial modification. It mainly involves the full implementation of the system of listing license holders, the 60-day time limit for clinical application of new drugs, the filing management of clinical trial institutions, and the elimination of GMP and GSP certification.


3. Drug registration management measures

On October 23, the CFDA issued the "Regulations on the Administration of Drug Registration (Revised Draft)" and publicly solicited opinions from the public. The drug registration management method is the departmental law and is the supporting document of the drug management law. The two are the relationship between the “parent” and the “child”.


Key points

◎Implementation of the system for listing license holders: The “Listing License Holder System” is included in Article 6 of the revised General Regulations and becomes one of the key contents of the adjustment; the holders of drug marketing licenses are safe and effective for listed drugs. Sexuality and quality controllability are continuously investigated and studied, fulfilling the life cycle management of drugs and taking legal responsibility.


◎ The time limit for review and approval is more clear: for the listing application of drugs, the preliminary review will be completed within 20 working days from the date of acceptance, and the comprehensive review of the new drug marketing license will be completed within 100 working days, generic drugs, biosimilar drugs, traditional drugs. It takes 120 working days for the application for marketing approval. If additional information is required, the total length of the technical review time will not exceed 1/3 of the original time limit. In addition, for drugs that are first applied for listing in China, if the applicant uses overseas test data to declare the listing, it should provide clinical trial data on whether there are ethnic differences.


◎ Data protection: The data protection period starts from the date when the drug is approved for listing. During the data protection period, the drug evaluation agency no longer approves other applicants for the same type of marketing permission application, and the applicant has obtained the approval of the marketing approval or other application. Except for data obtained by people themselves


10 kinds of non-approved listings

◎ The preliminary review results of the application materials are not in compliance with laws and regulations or are not evaluable;


◎The comprehensive evaluation of innovative drugs does not have clear clinical value;


◎The improved new drug does not have obvious clinical advantages compared with the original variety;


◎ The quality and efficacy of the generic drug and the original drug or reference preparation are inconsistent; the biosimilar drug is not equivalent to the quality and efficacy of the original drug or reference drug; the traditional Chinese medicine compound preparation and traditional application from the classic prescription are in the prescription, production process, Inconsistent in terms of route of administration, indications for function, etc.;


◎ According to the on-site inspection and registration test results, it is determined that the application has serious defects in safety, effectiveness, quality controllability, etc.;


◎ In the process of registration management, it is found that the application materials or filing information are not true or the applicant is unable to make a reasonable explanation for the issue of authenticity;


◎ The design and implementation of the research project cannot support the evaluation of the safety, effectiveness and quality controllability of the applied drugs;


◎ Chinese medicine prescriptions contain endangered herbs, which cannot guarantee the sustainable use of resources;


◎ The drug approval certificate shall be revoked in accordance with the provisions of the Drug Administration Law of the People's Republic of China;


◎ Other risks are greater than the benefit and obviously do not have the listing value.


4. Generic drug consistency evaluation

For the evaluation of generic drug consistency, we should focus on the four “government support” of priority procurement, medical insurance support, production support, and extensive publicity.


In the case of “priority procurement”, if the number of production enterprises that have passed the consistency evaluation of the same variety of drugs reaches 3 or more, the products that fail the consistency evaluation may be excluded from the scope of the catalogue when the local medicines are purchased intensively.


Regarding “medical insurance support”, the relevant departments are speeding up the formulation of medical insurance drug payment standards according to the common name, and appropriately supporting the medical insurance payment through the consistency evaluation, and encouraging clinical priority use.


In terms of “production support”, pharmaceutical manufacturers are expected to apply for financial support from central infrastructure investment and industrial funds if they are technically reformed through a consistent drug evaluation line.


In terms of “widespread publicity”, the CFDA intends to publish a type of announcement for the drug that passed the consistency evaluation, and incorporate it into the catalogue of alternative medicines with the original research drug, and form the Chinese Orange Book. For the varieties that pass the consistency evaluation, the “pass consistency evaluation” is used.


Among them, the “Certificate of Consistency Evaluation” and the China Orange Book are particularly worth mentioning. The “consistent evaluation mark” is printed on the outer packaging, which is convenient for the old white name to be seen; while the Chinese orange book indicates that China is becoming more and more standardized.


For the deadline for consistency evaluation of related products, the end of 2018 is the deadline for the first batch of products, and there will be a new batch in 2019. It was originally planned to fully complete the conformity evaluation of generic drugs by 2020, and it seems that it may be until 2025.


In addition, the main body of the conformity assessment review has been adjusted to the drug trial center. The specific problems encountered by enterprises in the research can be consulted with the drug review, and the drug review center will study the problems raised by the enterprise.


5. Special inspection of Chinese herbal extracts

For the CFDA to issue the Notice of the General Office of the Food and Drug Administration on the Special Inspection of Chinese Medicine Extracts on August 1 (Food and Drug Administration Drug Control [2017] No. 109), it is necessary to pay attention to the following four aspects. :


◎ Chinese medicine extract production enterprises focus on inspection: the production of the extracts; the organization of production according to the requirements of the drug GMP; whether there is the purchase of Chinese medicine extracts for OEM production.


◎ Key inspections of Chinese medicine manufacturers: the use of extracts for filing; the quality assessment of extracts and supplier audits; whether materials are balanced during production; whether there are illegal extracts.


◎ Key inspections of pharmaceutical production enterprises that share and relocate workshops in the group: the inspection and approval of the provincial food and drug supervision bureau; the production and quality management of extracts; whether the quality control measures in the storage, packaging and transportation of extracts are sufficient .


◎ Implementation of the filing of Chinese medicine extracts by the provincial food and drug supervision bureau: the overall situation of the implementation of the filing of extracts; whether the enterprises and varieties that have been filed meet the requirements of Document No. 135, and whether the filings that do not meet the requirements have been processed; Daily supervision and extension inspection of the variety.


The author believes that for Chinese medicine, the state is supportive. However, if you want to be cautious about the production of Chinese herbal extracts, due to many problems, the relevant government departments attach great importance to it and are working on it. It is reported that in the future, Chinese medicine should also be evaluated clinically.


In addition, the traditional Chinese medicine formula granules, which are eye-catching in the industry, are not satisfactory. How should Chinese medicine formula granules set industry standards? At present, there are 34 pilot enterprises for Chinese medicine formula granules. Hubei “Draft for Comment” is the seventh province to release formula pellets after six provinces including Zhejiang, Jiangxi, Heilongjiang, Henan, Anhui and Guangdong. Together with the previously approved national and provincial pilots, there are now 34 The pharmaceutical company obtained the pilot qualification of Chinese medicine formula granules, involving 12 provinces and cities and 15 listed companies. Among them, the national pilots include Sichuan New Green, China Resources Sanjiu, Beijing Kangrentang (Hongri Pharmaceutical), Guangxi Peili Pharmaceutical, and Chinese Traditional Medicine (Jiangyin Tianjiang, Guangdong).


6. Centralized procurement of drugs

Figure 1 Characteristics and development trends of centralized drug procurement

The characteristics and development trends of centralized drug procurement are shown in Figure 1. Many of the links in the figure are the key words for success after the drug is marketed. In other words, drugs do not enter the medical insurance directory, everything is fine. Admission (winning bid) is the first step, the second step is hospital procurement, and the third step is the enterprise sales marketing strategy, the most important of which is “access”.


It should be noted that under the big policy, it is possible to do some fine-tuning to adapt to local conditions in every place. For example, the drug distribution party in Guangdong Province is a circulation enterprise, and the drug distribution party in Shanghai is a production enterprise.


More cities explore GPO, medical insurance intervention, provincial finalists, city-level confirmation, the rise of medical association procurement, and encourage cross-regional joint procurement, which is the five major trends in drug recruitment in the first half of 2017.


In addition, the trend of volume and price declines needs to be closely watched. The reason is that all provinces and cities generally reduce the catalogue of drug purchases, a large number of drugs lose the opportunity to enter the market because they cannot enter the catalogue; the second is the three-in-one trend of “access + purchase + sales”, market access and bidding for drugs The three links that were originally disconnected from the sale were almost integrated under the new drug procurement method.


7. "Two-vote system"

The latest local developments in the implementation of the “two-vote system” are as follows:


Eleven provinces and cities including Fujian, Anhui, Chongqing, Qinghai, Shaanxi, Shanxi, Ningxia, Liaoning, Tianjin, Heilongjiang, Sichuan, and Guangxi (pilot cities) have entered the formal implementation stage.


In October, four provinces including Jilin, Hunan, Gansu (three-level hospitals), Yunnan (provincial hospitals and pilot city tertiary hospitals) entered the implementation phase. Among them, Hunan has experienced a six-month transition period since April, and some remote counties and townships can add one vote to the grassroots of two votes.


The five provinces of Hainan, Hebei, Zhejiang, Inner Mongolia and Shandong will officially implement the two-vote system from November. Among them, Hainan is the province with the most relaxed definition of production enterprises. The definition of Zhejiang is the most elaborate; the implementation scope of Hebei, Inner Mongolia and Shandong has gradually expanded from small to large.


The four provinces and cities of Shanghai, Beijing, Henan, and Jiangxi are expected to be implemented years ago, but the implementation rules are not specified. The implementation rhythm of Jiangsu and Guizhou is consistent with the procurement of drug bidding, which is in line with the market reality and is convenient for manufacturers and medical institutions to purchase and supply.


On October 16th, Tibet introduced the “two-vote system” implementation method, which clearly states that the “two-vote system” will be implemented before January 1, 2018. The conditions permitting implementation can be implemented in advance; the pilot cities for public hospital reforms should be implemented before the end of 2017. Two-vote system."


Regarding the "two-vote system", it is still necessary to pay attention to the local fine-tuning under the big policy. At present, Shaanxi, Qinghai and Fujian are also included in the "two-vote system" for consumables. The total domestic representation of the same as the original production enterprises in Chongqing, Guangxi, Yunnan. On October 26th, Chongqing’s “two-vote system” implementation plan (for trial implementation) reduced one word “inside” on the basis of the original document. The listed licensors are regarded as producing enterprises in Tianjin, Shanxi, Jilin, Jiangsu, Anhui, Hunan, Chongqing, Gansu, Zhejiang, Guangxi, Hubei, and Inner Mongolia. Gansu, Tianjin, Inner Mongolia, Jiangsu, and Zhejiang are clearly defined in property transfer enterprises.


According to the author's understanding, the "two-vote" rules being developed include: supporting the establishment of different places, depending on the situation, "three votes"; low-cost drugs, shortage of medicines, national reserve drugs and special drugs prescribed by the state may not be implemented. Two-vote system." It is clearly stated that three conditions are allowed to open “three votes”: the national general agent that transfers all the domestic or domestic original research products distribution rights (including operation and sales rights, distribution rights) can be regarded as the same as the production enterprise, and the national general agent filing system is established. The filing conditions must be met at the same time: the overall transfer of the distribution rights; the contract period is more than 3 years and there is specific compliance; there is only one general agent in the country. In addition, the State Council Medical Reform Office and the State Administration of Taxation will jointly check the votes.