Drug approval reform clear timetable to meet the industry reshuffle

　　Caixin.com (apprentice reporter Liu Jiaying) the much-watched reform of the drug approval system, finally has a timetable On August 18, the State Council officially issued the Opinions on Reforming the Review and Approval System for Pharmaceutical Medical Devices (the "Opinions"), proposing to complete the quality consistency evaluation of oral and reference preparations for essential drugs by the end of 2016 by the end of 2016.　　On the day of the publication of the Opinion, Wu Wei, deputy director of the State Food and Drug Administration, said publicly at a press conference that the current backlog of drug reviews is relatively serious, the number of drugs to be reviewed reached 21,000, although the state has improved the standard of drugs and quality certification level, but "drug standards are not high enough, relatively backward management, review and approval system is not smooth, the mechanism is unreasonable" and other issues are still outstanding.　　Therefore, this round of drug approval system reform will focus on "improve the quality of review and approval, solve the backlog of registration applications, improve the quality of generic drugs, encourage research and the creation of new drugs, improve the transparency of review and approval" five objectives.　　In order to achieve these five objectives, the Opinion proposes to continue to implement the "conformity evaluation of the quality of generic drugs", and generic drugs that have been listed will be evaluated in phases according to the principle of consistency with the quality and efficacy of the original drug.　　In addition, the Opinion also clearly "to carry out a drug market licensing licensing system pilot", the implementation of "drugs and pharmaceutical packaging materials, pharmaceutical accessories related approval" system, the concept of "new drugs" from "drugs not sold in China" to "drugs not listed for sale in China or abroad."　　In response to the long-suffering problem of the small number of drug evaluation center personnel, Wu said that the drug review center will use social resources, including scientific research institutions, institutions of higher learning, etc., through the purchase of services, to deal with a huge backlog of drug registration applications.　　Wu further pointed out that the above measures "if the comprehensive policy", the General Administration of Food and Drug Administration is confident that by 2017 to achieve the annual entry and exit balance of drug registration applications and review selling, 2018 to achieve the prescribed time limit approval In addition, the "Opinion" will improve the quality of listed drugs, promote innovation and transformation and upgrading of the pharmaceutical industry.　　However, the "Opinion" issued by the State Council is only a comprehensive program, the specific implementation of a series of supporting rules Beijing University International Research Center for Medical Management, Dr Guan Xiaodong told Caixin reporters that the drug backlog and the quality of generic drugs, "not today a civilized year can be resolved", before the end of 2016 to digest the long-term backlog of drug applications I am afraid "cannot do."　　Chen Zhen, a professor at Zhengzhou University's School of Pharmacy who has worked in the drug evaluation center for 14 years, told Caixin that drug approval is an integral part of the country's entire drug regulatory system, but at present the positioning of the national drug regulatory objectives is not clear, industrial development plans are not clear, "no purpose and objectives, policy has no direction, the whole industry does not know which direction to go."　　Improve the quality of generic drugs "Now we have the 21,000 varieties in the trial, 90% is the generic drug", of which "eight varieties, there are more than 100 enterprises in the declaration, there are 23 varieties, there are 50-99 declarations." Referring to the current situation of the drug review backlog, Wu reported a series of figures He said that the review backlog is largely due to China's generic drug standards are not high, enterprises repeat the phenomenon of serious, raise the standard, this phenomenon will be alleviated.　　For a long time, due to China's weak ability to independently research and develop drugs, domestic pharmaceutical companies can only imitate other countries have passed the patent protection period of patent drugs, the production of alternative drugs However, according to China's long-established quality standards for generic drugs, generic drugs only need to be consistent with the active ingredients, appearance and shape of the original drug, for the route of administration, dosage, use conditions and clinical effects of the requirements are not clear If the original research drug can not be found, pharmaceutical companies can have domestic listing of other generic drugs as imitation objects.　　"Low standards" directly lead to poor quality of drugs, low entry threshold for pharmaceutical enterprises and other issues Wang Chenguang, a scholar who specializes in the Drug Administration Law And dean of Tsinghua University Law School, told Caixin, "Our country has a large number of generic drugs, I imitated others and imitated me, each imitation allowed to have a certain quality error, these errors added to the end is very large", the quality of generic drugs can not be guaranteed.　　The situation has changed since 2007 In 2007, the General Administration of Food and Drug Administration announced a new version of the Measures for the Administration of Drug Registration, which requires that "generic drugs have the same active ingredient, route of administration, dosage form, specification and same therapeutic effect as generic drugs" The top of the pair raised the standard of imitation of generic drugs.　　However, the new version of the Drug Registration Management Measures still have limitations, it does not specify whether the generic object of generic drugs must be the original drug, and still provides that "the listed drugs to change the dosage form, change the route of administration, increase the registration of new indications in accordance with the procedures for the application of new drugs."　　"The approval time is slow, mainly because our country is relatively wide, the approval volume is relatively large." Wang Chenguang said that changing the route of administration, change the dosage form is not a new drug, but in accordance with the procedures of new drugs, take up a large number of drug evaluation center human and material resources.　　Although the Opinion issued by the State Council, it is clear that new drugs can only be "drugs not listed and sold in China or abroad", the generic object of generic drugs must be "original research drugs", but it and the existing "Drug Registration Management Measures" provisions conflict.　　In addition, for the 2007 "Drug Registration Management Measures" before the implementation of generic drugs, although the General Administration of Food and Drug Administration in 2012 launched the generic drug "quality consistency evaluation", and the State Council in the "Opinion" again mentioned that the "consistency" controversy has been there.　　Chen Zhen told Caixin reporter, quality consistency evaluation started up to now, an important reason for slow progress is that many generic drugs simply "cannot find the original research drugs", these drugs before the generic object may be other generic drugs, the country does not have a statutory original research drugs or reference drug catalog, "drug companies do not know who is the original research drugs."　　On the other hand, the pharmaceutical industry for "what is consistency" has different views, some people think that tablets, capsules, as long as the in vitro dissolved curve is consistent, you can think of consistent quality, and some people think that in vitro dissolving curve consistent can not guarantee the same clinical efficacy of drugs.　　For the above-mentioned problems, Wu Pointed in the press conference, can not find the original research drugs, on the internationally recognized advanced products as a benchmark, "consistency" evaluation to in vitro solubility test as the basis, at the same time must do bioequivalence test.　　But Chen Zhen said that the lack of a legal reference drug catalog has caused many problems for generic drug research and development and registration review, and for the consistency evaluation of generic drugs Based on the long-term development of generic drugs, the state should learn from the experience of the United States and other regulatory agencies, the introduction of the statutory original drug catalog Only when a catalogue is introduced can the reference to generic consistency have a solid basis.　　The pilot listing licensor system The low threshold for market access for generic drugs is only one factor that has led to a serious drug backlog As Wu said, the drug review backlog is "a complex process", "both historical and practical", "both institutional factors and institutional situations".　　The so-called "institutional situation" includes "always binding the approval number of the drug to the enterprise", "the developer can only sell the product to the enterprise", or run its own pharmaceutical factory Wu said that the approval number and product production is not separated, increasing overcapacity and duplication of construction.　　The "listing licensor system" proposed in the Opinion is to solve the problem of duplication of construction, while encouraging innovation Wang Lifeng, director of the Pharmaceutical Registration Department of the State Administration of Food and Drug Administration, said that "in the past, the law stipulated that the drug approval number must be approved to the enterprise", "a batch of drugs must be built an enterprise", and now the reform proposal has expanded the scope, scientific research units can also have the drug approval number.　　The significance of the listing licensor system also lies in the restructuring of industry resources Wang Chenguang told Caixin reporter, "batch a drug issued a drug code", so that "the industry is small, scattered, disorderly, 'small' is a factory in the county to make a production line said I want to produce can build a product line, 'scatter' is everywhere flowering, where are pharmaceutical companies, 'chaos' is a variety of irregularities."　　After the implementation of the listing licensing system, research and development institutions to obtain a listing license, do not need to set up their own pharmaceutical plants, can give production to another enterprise, so that, the research and development capacity of pharmaceutical enterprises focus on research and development, production capacity of pharmaceutical companies to do processing, industry unions more and more professional, the intensity of the entire industry will also be increased.　　In the event of a problem with a drug, the licensed unit shall be solely responsible for the quality of the drug, and the enterprise assisting in the processing of the drug shall be held responsible in accordance with the contract between the two parties This creates a clear system of responsibility and facilitates drug regulation.　　"The listing licensor system is a very important system, if established, the status quo will have a more obvious change." Chen Zhen said that if this system is only on the pilot of innovative drugs, because "the number of innovative drugs approved for production and marketing is very limited each year, according to the compound, approved to market the chemical innovative drugs in the past few years are few, and most of them are declared by the production enterprises", by the research and development agencies simply put forward a new drug certificate application number is very small, this situation in the next few years will not have a big change, "so the pilot significance of innovative drugs is very limited."　　Mr Chen explained that the listing licensor system, which had been under discussion for many years, had only recently been formally accepted by the government because of concerns that China's research and development institutions and companies would not be able to shoulder so much responsibility However, Chen Zhen believes that each system has potential risks, as long as the regulation is in place, you can control the risk.　　Change the regulatory thinking Although the Opinion swayed a number of policy positive signals, such as the "new drug" limited to "drugs not listed for sale in China or abroad", but this is different from the current "Drug Registration Management Measures" "New drug applications, refers to the registration application for drugs not sold in China" this provision is obviously different.　　The above-mentioned differences are related to the lag in the thinking of the existing drug regulation laws and regulations Chen Zhen said that the drug approval system reflects the national drug regulation, and China's drug regulatory laws and regulations have always stressed the "protection of the public's drug safety", "this goal is too low", "as long as nothing happens is the bottom line", but the United States and other countries, the purpose of drug regulation is generally "to protect and promote public health", which means not only to protect the public drug safety, but also to encourage innovation, so that patients benefit.　　In Chen Zhen's view, the positioning of the purpose of drug supervision is not clear, drug registration laws and regulations are not perfect, the distribution of regulatory resources is unreasonable, and drug-related policies can not be well connected between the various reasons caused by the backlog of drug review and approval is periodic The backlog of review approvals is not a phenomenon in the last two years, and there have been many instances in China in the past, such as the backlog of 27,000 registration applications for drug evaluation centres prior to the centralized review in 2008.　　China has always been a big country of generic drugs, but with the trend of globalization becoming more and more obvious, many international students choose to return home to develop new drugs, coupled with the establishment of the country's innovative drug research and development of major special projects, "local new drugs" are rising However, the change of thinking in drug regulation has clearly not kept pace with market changes.　　Su Ling, a former chairman of the Global Council of the Drug Information Association, told Caixin that the potential thinking of China's drug regulatory laws and regulations has been influenced by "generic drugs" and did not take into account the characteristics of innovative drugs.　　Su Ling further pointed out that the current drug approval system for clinical trialrequirements are very strict, applicable to generic drugs, "because a focus of generic drug regulation is not chemically a thing", there are certain goals, but "innovative drugs in the research and development process, quality control, production process is constantly improved", in the clinical trial stage of new drugs can not determine that the drug must be effective.　　Another idea that affects government drug regulation is the "planned economy" Su Ling explained that China's drug regulatory system was established, the resources and experience is insufficient, so the approval of drugs often take a "one-size-fits-all" approach, such as the number of clinical trials "China's approval is largely administrative approval rather than scientific approval", "in the past when there was no experience to do so, but now to enter the stage of scientific supervision rather than administrative ticking".　　The "plan" mentality also manifests itself in the government's attemptto stake in all the responsibilities of the quality of medicines Wang Chenguang said that under the current drug approval system, the drug evaluation center is more like a drug company's laboratory, whether the drug is effective, how the quality of the drug evaluation center first by the drug evaluation center, the responsibility of the enterprise has become secondary.　　"Regulation is not an overtake", "the government should not be in charge of all, old worry about no matter what the mess can do", but "the government always has the last time to back up." Wang Chenguang pointed out that in this round of drug approval system reform, the government has begun to adjust its role, "the responsibility of drug-in-the-non-conforming room enterprises, the government's responsibility is to urge enterprises to assume."　　Chen Zhen also told Caixin reporter, who is the first responsible person for the quality of drugs has been controversial for a long time, but at least the drug regulatory department has understood that the enterprise is the first responsible person Before the State Council issued the Opinion on the Reform of the Drug Approval System, the General Administration of Food and Drug Administration had made some attempts in the areas of new drug approval and drug regulatory responsibility, but suffered from a lack of legal support.　　The Opinion, in the last part of the document, specifically lists the task of "accelerating the revision of laws and regulations", saying that it is necessary to "promote the accelerated revision of the Drug Administration Law of the People's Republic of China, in conjunction with the reform of the administrative examination and approval system, to urgently revise the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Measures for the Administration of Drug Registration in accordance with the procedures, or to bring about a more radical change in the drug approval system." 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