Seven of 2017's most far-reaching medical policies

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


1. "two offices 36"


On October 1, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices", and proposed 36 important reform measures (referred to as "36 Articles of the Two Offices"). This is a document issued by the highest government agency.

The policy is clear: to promote new drug innovation, promote the development of generic drugs, has been listed injections and devices to carry out re-evaluation research. This policy is good for the development of rare disease drugs, children's special drugs, innovative therapeutic biological products, biological similar drugs, and drug combination products with clinical value. API no longer issue approval number, injection and medical device re-evaluation policy, will certainly cause the relevant listed products market changes.

Eg. Key points

◎ Reform clinical trial management, speed up the listing review and approval, promote drug innovation and generic drug development, strengthen the life cycle management of drugs and medical devices, improve technical support capabilities, and strengthen the organization and implementation of six aspects to encourage drug and medical device innovation.

◎ Special attention should be paid to such important policies as reevaluation of injections, prohibition of drug sales by medical representatives, strict control of oral preparations into injections, publication of rare disease catalogues, and appropriate patent term compensation for delays in listing due to clinical trials and review and approval.


Understanding the implementation rules and correctly analyzing the impact on the pharmaceutical industry is key.

On the one hand, it simplifies the administrative 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 the listing licensor.

On the one hand, speed up the approval of new drug devices, including special approval for rare diseases and clinical expansion applications, strengthen the protection of clinical data and the use of foreign data to encourage new product development.

The policy focuses on research and development innovation, and also mentions the circulation and promotion of drugs. The core content is consistent with the No. 13 document issued by the State Council.

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


2. Drug Administration Law


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

The reason why the drug administration law is highly valued is that it is the only law in the pharmaceutical industry, which needs to be voted by the National people's Congress, while other pharmaceutical industry laws are only departmental laws.

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


Measures for the Administration of 3. Drug Registration


On October 23, CFDA issued the "Measures for the Administration of Drug Registration (Revised Draft)" to solicit public opinions. The drug registration management method is the departmental law and the supporting document of the drug management law. The two are the relationship between "parent" and "child.

Eg. Key points

◎Implementation of the listing permit holder system: The "listing permit holder system" is included in Article 6 of the General Provisions of this revised draft and has become one of the key contents of the adjustment; the drug listing permit holder is safe and effective on the listed drugs Carry out continuous investigation and research on the effectiveness and quality controllability, perform the full life cycle management of drugs, and bear legal responsibilities.

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

◎ Data protection: The data protection period starts from the date when the drug is approved for listing. During the data protection period, the drug review agency will no longer approve other applicants' applications for the same variety of marketing license, with the consent of the applicant who has obtained the marketing license or other applicants. Except for the data obtained by themselves

910 10 Cases of Not Approved Listing

◎ The preliminary examination results of the declaration materials do not meet the requirements of laws and regulations or do not have evaluability;

◎ Innovative drugs that do not have clear clinical value after comprehensive evaluation;

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

◎ Inconsistent with the quality and efficacy of the generic drug and the original drug or reference preparation; inconsistent with the quality and efficacy of the biosimilar drug and the original drug or reference drug; inconsistent with the prescription, production process, route of administration, function and treatment of the traditional Chinese medicine compound preparation derived from the classic prescription;

◎ According to the results of on-site inspection and/or registration inspection, 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 cannot make a reasonable explanation for the authenticity problems;

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

◎ Chinese medicine prescription drugs containing endangered medicinal materials, can not guarantee the sustainable use of resources;

◎In accordance with the provisions of the "the People's Republic of China and Drug Administration Law", the drug approval certificate should be revoked;

◎ Other situations where the risks outweigh the possibility of benefit and are clearly not of listing value.


Consistency Evaluation of 4. Generic Drugs


For the consistency evaluation of generic drugs, we should focus on the four "government supports" of priority procurement, medical insurance support, production support and extensive publicity ".

In terms of "priority procurement", there are 3 or more manufacturers of the same variety of drugs that have passed the consistency evaluation. When centralized procurement of drugs in various regions, products that have not passed the consistency evaluation may be excluded from the scope of the purchase catalog.

In terms of "medical insurance support", the relevant departments are speeding up the formulation of medical insurance drug payment standards according to generic names, giving appropriate support to medical insurance payment for drug varieties that have passed the consistency evaluation, and encouraging clinical priority use.

In terms of "production support", pharmaceutical manufacturers are expected to apply for financial support such as central infrastructure investment and industrial funds if they carry out technological transformation of pharmaceutical production lines that have passed the consistency evaluation.

In terms of "wide publicity", the CFDA intends to issue a special class of announcements for drugs that have passed the consistency evaluation, including them in the list of drugs that can be replaced with the original drug, and form a Chinese orange book. Varieties that pass the consistency evaluation will be identified by "pass the consistency evaluation.

Among them, "through the consistency evaluation logo" and the Chinese orange peel book are particularly worth mentioning. The "consistency evaluation mark" is printed on the outer package, which is convenient for Lao Bai to see. However, the Chinese orange peel book indicates that our country is becoming more and more standardized.

For the deadline for consistency evaluation related products, the end of 2018 is the deadline for the first batch of products, and there will be a new batch in 2019. The original plan was to complete the generic drug consistency evaluation by 2020, and now it seems that it may be 2025.

In addition, the main department of consistency evaluation review has been adjusted to the drug review center. The specific problems encountered by the enterprise in the research can be consulted by the drug examination center, and the drug examination center will study the problems raised by the enterprise.


Special Inspection of 5. Traditional Chinese Medicine Extracts


For the CFDA issued on August 1, the General Office of the Food and Drug Administration on the development of traditional Chinese medicine extract special inspection notice (food and drug administration office drug supervision [2017] 109), need to focus on the following four aspects of the relevant details:

◎ Key inspection of traditional Chinese medicine extract production enterprises: record of extract production; Organize production according to GMP requirements; Whether there is any outsourcing of traditional Chinese medicine extract for OEM production.

◎ Key inspections of Chinese medicine manufacturers: record use of extracts; Quality assessment of extracts and audits of suppliers; Whether there is material balance in the production process; Whether there is any use of illegal extracts.

◎ The key inspection of drug manufacturers that share and set up extraction workshops in different places within the group: the examination and approval of the provincial food and drug administration; the production and quality management of extracts; whether the quality control measures in the storage, packaging and transportation of extracts are adequate.

◎ Implementation of the filing of traditional Chinese medicine extracts by the provincial food and drug administration: overall situation of the filing of extracts; Whether the enterprises and varieties that have been filed meet the requirements of document No. 135 and whether the filing that does not meet the requirements has been handled; Daily supervision and extended inspection of filing enterprises and varieties.

The author believes that the state is supportive of traditional Chinese medicine. However, if you want to invest in the production of traditional Chinese medicine extracts, you need to be cautious. Due to many problems, the relevant government departments attach great importance to it and are starting to deal with it. It is reported that in the future, traditional Chinese medicine should also be evaluated clinically.

In addition, the traditional Chinese medicine formula granules, which are popular in the industry, are not satisfactory. How to formulate industry standards for Chinese medicine formula granules? At present, there are 34 pilot enterprises of Chinese medicine formula granules. Hubei's "Draft for Solicitation of Comments" is the seventh province to release pilot formula granules after 6 provinces including Zhejiang, Jiangxi, Heilongjiang, Henan, Anhui, and Guangdong. Together with the previously approved national and provincial pilots, there are now 34 Pharmaceutical companies have obtained the qualification for the pilot of Chinese medicine formula granules, involving 12 provinces and cities and 15 listed companies. Among them, the national pilot includes Sichuan New Green, China Resources Sanjiu, Beijing Kangrentang (Red Sun Pharmaceutical), Guangxi Peili Pharmaceutical, Chinese Medicine (Jiangyin Tianjiang, Guangdong side).


Centralized procurement of 6. drugs


Figure 1Characteristics and development trend of centralized drug procurement 

The characteristics and development trend of centralized drug procurement are shown in Figure 1. Many links in the figure are key words for the success of drugs after they are on the market. In other words, drugs do not enter the medical insurance catalog and everything will be fine. Access (winning the bid) is the first step, the second step is hospital procurement, and the third step is the company's sales and marketing strategy. The most important thing is "access".

It should be noted that under the general policy, it is possible for each place to make some fine-tuning to adapt to local conditions. For example, the drug distributor in Guangdong Province is a distribution enterprise, while the drug distributor in Shanghai is a production enterprise.

More cities are exploring GPO, medical insurance is involved in recruitment, provincial shortlisted, municipal standard confirmation, the rise of medical alliance procurement, and the encouragement of cross-regional joint procurement, which are the five major trends in drug recruitment in the first half of 2017.

In addition, the trend of falling volume and price needs to be closely watched. The first reason is that all provinces and cities generally reduce the drug procurement catalog, and a large number of drugs lose the opportunity to enter the market because they cannot enter the catalog; the second is the three-in-one trend of "access, procurement and sales", market access and bidding for drugs The three originally disconnected links of sales are 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, municipalities, including Fujian, Anhui, Chongqing, Qinghai, Shaanxi, Shanxi, Ningxia, Liaoning, Tianjin, Heilongjiang, Sichuan, and Guangxi (pilot cities) have entered the formal implementation stage.

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

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

Shanghai, Beijing, Henan and Jiangxi provinces and cities are expected to be implemented by the end of the year, but there are no specific implementation rules. The pace of implementation in Jiangsu and Guizhou is consistent with drug bidding and procurement, which is in line with market reality and facilitates the procurement and supply of manufacturers and medical institutions.

On October 16, Tibet issued the implementation measures of the "two vote system", which made it clear that the "two vote system" would be implemented before January 1, 2018, and could be implemented in advance if conditions permit; the pilot cities of public hospital reform should implement the "two vote system" before the end of 2017 ".

For the "two-vote system", we should still pay attention to the local fine-tuning situation under the big policy. At present, consumables are also included in the "two-vote system" of Shaanxi, Qinghai, Fujian. The total generation in the territory is regarded as the original Chongqing, Guangxi and Yunnan of the production enterprises. On October 26, Chongqing issued the "two-vote system" implementation plan (for trial implementation), which reduced the word "within" on the basis of the original document ". The listed licensors regard Tianjin, Shanxi, Jilin, Jiangsu, Anhui, Hunan, Chongqing, Gansu, Zhejiang, Guangxi, Hubei and Inner Mongolia as production enterprises. There are clear provisions on the transfer of property rights enterprises in Gansu, Tianjin, Inner Mongolia, Jiangsu, Zhejiang.

According to the author's understanding, the detailed rules of the "two-vote system" being formulated include: supporting the establishment of warehouses in different places, and "three votes" can be issued according to the situation; low-priced drugs, drugs in short supply, national reserve drugs and special drugs prescribed by the state can temporarily not implement the "two-vote system". It is clearly stated that "three votes" are allowed under three circumstances: the national general agent who transfers all the distribution rights (including operation, sales rights and distribution rights) of imported to domestic or domestic original research products can be regarded as the production enterprise, and a national general agent filing system must be established. The filing conditions must be met at the same time: the distribution rights are transferred as a whole; The contract period exceeds 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 tickets.