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40 years of reform and opening-up: changes in China's drug r&d environment

2018年12月31日

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40 years of reform and opening-up: changes in China's drug r&d environment

Source: yaozhiwang

2018-11-22


Author: yao xiaohui



During the 40 years of reform and opening up, how has China's drug r&d environment changed? What reforms have been made to the policy on drug transfer of technology? See below.


Reform and opening up 40 years drug research and development environment changes


I. basic research


In the past five years, China's innovative drug research and development has been greatly improved. Especially in 2017, there has been a significant increase in the application of domestic and biological innovative drugs, and the application of biological innovative drugs in 2017 has increased by 126.7% compared with that in 2016.




Figure 1-2-1 application of innovative drugs in 2013-2017 (varieties)


However, based on the analysis of the innovative drugs that have been listed and declared in China in the past five years, it is not difficult to find that it is basically the tracking innovation on the known targets. The basic research and transformation research in China are relatively weak, and the deep-seated innovation ability still needs to be strengthened.


In contrast, European and American pharmaceutical powers are mainly engaged in new drug research and development in three main categories [1] :


1. Universities and non-profit research institutions


Research on the mechanism of disease -- discovery of new drug targets and creation of new clinical treatments; Establishment of novel drug molecules (platform technologies) (such as humanized and fully humanized therapeutic antibodies). The research funds mainly come from national and professional fund institutions. The successful way out of the research results is to license or transfer the technology to big pharmaceutical companies. Researchers get venture capital or government funding to set up small businesses in university science parks.


2. Technology-innovative small and medium-sized companies


Based on the independent innovation technology of the company's entrepreneurial personnel, the company is committed to the early research and development of new drugs. Funding comes mainly from early-stage venture capital. The way out is to be absorbed into a whole or part by a giant pharmaceutical company. Occasionally a small company will grow into a large company with excellent platform technology, such as Genetech in the United States, but it will be merged by Roche of Switzerland for nearly 50 billion dollars.


3. Super large pharmaceutical companies


A large number of first-class scientists and engineers are gathered together to conduct innovative drug molecular research and development for new targets based on mature platform technologies or innovative drug research and development for new and old targets based on new technology platforms with extremely fine technical division of labor and cooperation similar to factory assembly lines. Huge r & d funds come from the profits of enterprises and capital market funds, the outcome of the way out is product listing.


From the perspective of the new drug research and development in foreign pharmaceutical developed countries, the main body of new drug research and development is enterprises, and universities and research institutions mainly focus on basic research. Similarly, China's basic research strength is also mainly concentrated in scientific research institutes, such as Peking University school of pharmacy, China pharmaceutical university, shenyang pharmaceutical university, Shanghai institute of materia medica, Chinese academy of sciences state key laboratory of new drug research and so on. At present, there are also quite a number of innovative enterprises that cooperate with domestic research institutes or foreign research institutions to develop new drugs, or enterprises independently carry out research and development. The ways and methods of new drug research and development in China are gradually diversified, but they cannot leave basic research.


Which areas of disease are more difficult to develop new drugs? Alzheimer's disease comes to mind first. Although we have a certain understanding of the characteristics of alzheimer's disease, its pathogenesis has been in the "hypothesis" stage. It is not surprising, then, that new drugs for alzheimer's have failed repeatedly.


Drug supervision and regulation


The United States can become the world's top pharmaceutical empire, behind its powerful drug regulatory agency, the food and drug administration (FDA) has a close relationship. The reasonable and advanced guidance of FDA's policies and regulations in drug r&d, registration, supervision, circulation and other fields has great reference significance for drug supervision in China.


There are many historical problems and reforms in drug regulation in China. Reviewing every reform, most of them end up with the backlog of old problems and the emergence of new ones. The reform is not thorough and thorough. Therefore, since the state council issued the "opinions on the reform of the examination and approval system of pharmaceutical and medical devices" on August 18, 2015, China has once again carried out a radical reform of the examination and approval system of pharmaceutical and medical devices.


(I) reform of new drug regulatory regulations


1. Redefinition of new drugs


Definition of "drugs" in our country has experienced many times change, the definition of "drugs" from "not production of drugs in China" in 1985, to 2002 "did not go on sale in the territory of China medicine", and finally in 2015 identified as "not publicly listed company in China selling drugs", new drugs from China's "new" to the change of the world "new", groping for 30 years. Through continuous reform, China has the clearest understanding of innovative drugs, improved new drugs and generic drugs.


2. Carry out trials of the drug marketing permit holder system (MAH)


The establishment of the drug market permit holder system is a major reform of drug supervision in China. Before the introduction of MAH, China implemented the management mode of unified binding of listing license and production license. Only manufacturers could apply for drug registration and obtain the final drug approval document number. After the implementation of MAH, drug research and development was separated from drug production. Drug research and development institutions and researchers also had the approval number of drugs, which changed the pattern of drug research and development in China and was good for new drug research and development. At the same time, stricter requirements were put forward for the safety and effectiveness of drugs in the whole life cycle. The implementation of this system is conducive to promoting the rapid development of new drug research and development in China.


3. Reform of clinical trial management of new drugs


The qualification of clinical trial institutions shall be put on record. Institutions that meet the requirements for clinical trials may accept the entrustment of applicants for drug and medical device registration to conduct clinical trials after registration and filing on the websites designated by the food and drug regulatory authorities. The elimination of the GCP accreditation system for clinical trial institutions does not mean that the threshold for admission has been lowered. On the contrary, by increasing clinical research resources, the regulatory efficiency of clinical trial institutions can be enhanced, and the quality of clinical trials can be further guaranteed.


Optimize clinical trial approval procedures and apply for implied licensing system for clinical trials. Establish and improve the communication and exchange mechanism between the registered applicant and the appraisal institution. Before accepting the application for clinical trials of drugs and clinical trials of medical devices that need to be approved, the review and evaluation institution shall hold a meeting with the registered applicant to communicate and put forward opinions and Suggestions. Within a certain period of time after accepting the application for clinical trial, if the food and drug regulatory authority fails to give a negative or questioning opinion, it shall be deemed as an agreement. The registered applicant may carry out clinical trial according to the submitted scheme. The setting of the time limit puts pressure on the drug evaluation part, and the technical evaluation must be completed within the specified time. For enterprises, it reduces the risk that the review backlog leads to the excessively long review cycle and effectively adjusts the resources to be used reasonably.


To receive overseas clinical trial data. If the clinical trial data obtained from overseas multi-centers meet the relevant requirements for the registration of drugs and medical devices in China, they may be applied for registration in China. Positive steps have been taken to realize the simultaneous listing of domestic and foreign drugs.


(ii) reform of regulations and regulations related to generic drugs


"Generic drugs" are alternative drugs with the same active ingredients, dosage forms, drug delivery channels and therapeutic effects as the generic drugs. They have important economic and social benefits such as reducing medical expenses, improving drug accessibility and improving medical service level. The international community generally adopts the policy orientation of encouraging both innovation and imitation, and actively explores ways to promote innovation, supply guarantee and clinical use of generic drugs. India mainly promotes the development of generic drugs by setting strict standards for drug patent granting, strictly restricting "evergreen patents", emphasizing the deterrent effect of compulsory licensing and encouraging competent enterprises to actively apply for compulsory licensing. America by simplifying generics review approval process, promote the generics alternative use, set up the system of "Orange Book" (the United States will all the FDA approval, after the safety and efficacy evaluation and non-prescription medicines list), and publish them in the appendix part approved drug related patent information, published on a regular basis. Due to the orange color of the book cover, commonly known as "Orange Book"), the appropriate implementation of drug compulsory licensing policies, to promote the development of generic drug industry.


Since the reform and opening up, China's generic drug industry has achieved rapid development. The scale of the industry has been expanding and the number and variety of generic drugs have been constantly enriched. More than 95% of the nearly 170,000 drug approvals are generic drugs, making great contributions to the health of the general public. But also want to see, because of various reasons, generics industry in our country big but not strong, the situation of "more poor small scattered" still exists, the differences in drug quality, high quality pharmaceuticals market mainly occupied by foreign original drugs, drug prices artificially high part of the original, the people with the current demand for high quality generic drugs, compared to accessibility and affordability, we still have some gap, is an urgent need to reform and perfect.


1. Implementation of consistency evaluation


As early as 2013, the state food and drug administration proposed to carry out the quality and efficacy consistency evaluation of generic drugs. In 2015, the former state food and drug administration issued the "notice on the implementation of archival filing administration for bioequivalence tests of chemical drugs", and the BE test was changed from the approval of the state administration of food and drug administration to the archival filing by enterprises independently. It was not until March 2016 that the state council issued the "opinions of the general office of the state council on the consistent evaluation of the quality and efficacy of generic drugs" that the consistent evaluation was implemented. Various provinces and cities have also issued very powerful policies to support enterprises to carry out consistent work, including financial support, and give preferential treatment to bidding and procurement through consistent evaluation of varieties. The smooth development of drug consistency evaluation is of great significance to the standardization of generic drug market in China.


2. Establish the catalogue of listed companies in China


China listed catalogue, it has a more familiar name in the industry: China Orange Book. Similar to the Orange Book published by the FDA of the United States, the Orange Book of China has the same significance for drug research and development in China. It includes drugs with safety, effectiveness and quality control in China, and determines reference preparations and standard preparations for real-time update.


Develop a list of medicines that encourage imitation


From 2012 to 2016, a total of 631 patents of the original developed drugs expired globally. Due to information asymmetry, technical difficulties and the small market size of some drugs for rare diseases, the pace of imitation in China is still very slow. Many patents expired and no enterprises have applied for the registration of imitation. In establishing China listed directory is set on the basis of the formulated to encourage generic drugs directory, through to the registration priority review for examination and approval of the pharmaceuticals listed in the directory, in order to encourage guiding the development of pharmaceutical enterprises and research institutes, registration and production, make more research and development of pharmaceutical enterprises by way of open competition for generic rights, promote more clinical curative effect is necessary, and shortage of generic drugs listed as soon as possible, on the one hand can solve the problem of drugs part of the original price is too high, on the one hand can solve the problem of shortage of some medicines in our short, vigorously improve the accessibility of medicine and to ensure adequate supply.


In 2017, the former state food and drug administration officially became a member of the international human drug registration technical coordination committee (ICH), which means that China has taken a historic step on the road to internationalization of drug r&d and registration. After CFDA joins ICH, the pace of drug review and approval reform in China will accelerate.


4. Related approval of packaging materials for raw and auxiliary materials


Released in November 2017, the CFDA on the adjustment of API, pharmaceutical excipients and medicine packaging material review of examination and approval matters in the announcement, with direct contact with drugs for medicinal materials packaging materials and containers (hereinafter referred to as the medicine packaging material) for examination and approval, active pharmaceutical ingredients, pharmaceutical excipients and medicine packaging materials in pharmaceutical preparation for examination and approval of registration for examination and approval of the review. The examination and approval of drugs and pharmaceutical raw and auxiliary materials and packaging materials shall be carried out, and the quality requirements of raw and auxiliary materials shall be determined according to the production and quality requirements of preparations, so as to improve the scientificity and pertinence of the technical requirements of raw and auxiliary materials examination and evaluation and improve the quality of pharmaceutical raw and auxiliary materials and packaging materials. The implementation of the related review system of API terminated the approval document number system of API, which was also regarded as the transitional policy of DMF system.


(3) drug protection policies


1. New drug monitoring period


In the new drug examination and approval measures implemented in 1999, a new drug protection system is implemented, and the registration applications of other domestic enterprises are not accepted during the new drug protection period. At that time, China defined new drugs as "drugs not produced in China", that is, as long as a Chinese enterprise can copy the first foreign varieties, it can obtain the new drug protection period. For the varieties that have been approved for import, it is obviously unreasonable for the domestic enterprises that are the first imitators to still get the protection period of new drugs.


Therefore, the concept of "new drug monitoring period" was put forward in the drug registration administration measures (trial) promulgated in 2002. The state drug administration does not approve other enterprises to produce and import new drugs during the monitoring period.


The new drug monitoring period only targets at domestic drugs and does not monitor imported drugs. New indications have been added. No monitoring period has been set up for either 1.6 or 3.4 categories of chemical drugs in the 2007 drug registration administration measures.


In 2016, the registration and classification reform of chemical drugs divided domestic new drugs into innovative drugs and improved new drugs. Monitoring periods of different years can be set up (including the addition of new indications) to encourage the development of new drugs.


Table 1-2-5 term table of new drug monitoring period (note: no monitoring period shall be established except for the new drug under the following circumstances)




2. Drug intellectual property protection system


China's first patent law was promulgated on March 21, 1984 and came into force on April 1, 1984. At the beginning of its implementation, the patent law stipulates that no patent right shall be granted for drugs or substances obtained by chemical methods. The patent law, which came into force in 1993, removed drugs and substances obtained by chemical methods from the list of patents never granted, meaning that the protection of a compound patent could be applied from 1 January 1993.


The patent system plays a very important role in drug research and development. In October 2017, the general office of the state council issued the opinions on deepening the reform of the review and approval system to encourage drug and medical device innovation, which also put forward corresponding requirements for the protection of drug intellectual property rights.


Explore the establishment of drug patent link system. In order to protect the legitimate rights and interests of the patentee, reduce the risk of patent infringement of generic drugs, encourage the development of generic drugs, and explore the establishment of drug review and approval and drug patent link system.


We will carry out trials of a system for compensating drug patent deadlines. Some new drugs will be selected for pilot trials, and appropriate patent term compensation will be given for the delay in listing due to clinical trials and review and approval.


We will establish a system of priority examination and approval for drugs under compulsory patent licenses. In the case of a major threat to public health, priority shall be given to the examination and approval of applications for drug registration for which a compulsory license is granted.


We will improve and implement the drug test data protection system. When submitting the application for registration, the applicant for drug registration may submit the application for protection of test data at the same time. A certain period of data protection shall be given to the independently obtained and undisclosed test data and other data submitted by the applicant for registration of innovative drugs, drugs for the treatment of rare diseases, special drugs for children, biological products for innovative treatment and drugs that have successfully challenged the patent.


3. TCM protection system


The Chinese government attaches great importance to the protection of traditional Chinese medicine varieties and implements the protection system of traditional Chinese medicine varieties. In 1991, the state council included laws and regulations on the protection of traditional Chinese medicine varieties in the state legislative plan, which was led by the legislative bureau of the state council