The Dilemma of Drug Approval: From "Great Leap Forward" to "Great Traffic Congestion"

In the practical context, drug evaluation is a highly professional work, but it is intertwined between the local economy, enterprise development and the vast number of patients and various gray interests Now, the drug administration is trying to reform It will take 16 years to get the approval number "At the current review speed, Chinese patients have to take the drugs that have been developed, and they have to wait 16 years to get the approval number alone," Cheng Zengjiang told the Southern Weekend reporter, "it's too slow!" Cheng is the head of a drug research and development organization Similar to dissatisfaction with the efficiency of evaluation, it is an open topic in the pharmaceutical industry At the two sessions of the National People's Congress at the beginning of the year, a number of pharmaceutical enterprise representatives with the status of deputy to the National People's Congress or member of the CPPCC put pressure on the drug regulatory department to ask the drug review department to improve the review efficiency The opinions and suggestions received the attention of the National People's Congress, were regarded as 18 key suggestions, and the food and drug administration was obliged to coordinate with the relevant departments Some enterprises even use more intense "real name report" method to report to the State Council In July 2014, Ma Wenfang, a rural doctor in Henan Province, and Zhang Yi, chairman of Henan Yisheng Pharmaceutical Co., Ltd., reported malfeasance of the General Administration of food and drug under their real names, saying that they had delayed the approval of a product of Yisheng pharmaceutical for a long time without giving a clear approval conclusion "China's pharmaceutical market is suffering from regulatory problems and inefficient approval," John C Lechleiter, chief executive of Lilly pharmaceutical, said on the afternoon of November 11 at the Asia Pacific Economic Cooperation (APEC) business leaders summit The food and drug administration is clearly under pressure Since October, two public proposals have been made to reform the current drug approval system On October 24, the Party group of the General Administration of food and drug learned to communicate the Fourth Plenary Session of the 18th CPC Central Committee, and proposed to speed up the reform of the current review and approval system The earlier one was on October 9, when the Symposium on handling key suggestions of the second session of the 12th National People's Congress was held in the State Food and drug administration Wu Zhen, the deputy director in charge, and Wang Lifeng, the director of the registration department, appeared to respond to the query of the deputies to the National People's Congress and published relevant information on the official website This is a rare public response to this issue by the General Administration of food and drug South China learned from the participants over the weekend that the meeting lasted for more than two hours and was attended by government agencies such as the editorial office of the CPC Central Committee, the national development and Reform Commission and the Ministry of finance "Talked about the next step of reform ideas," a representative of the National People's Congress of the pharmaceutical industry told Southern Weekend reporters, "but it seems that people are still the difficulty." The responsibility for the approval of drugs entering the market in China lies with the General Administration of food and drug administration, and the specific responsibility lies with the drug review center The number of people working out the plan for this department directly under the State Food and drug administration is 120 The responsibility for the approval of drugs entering the market in China lies with the General Administration of food and drug administration, and the specific responsibility lies with the drug review center The number of people working out the plan for this department directly under the State Food and drug administration is 120 "As a matter of fact, only 50 have been approved for a long time Recently, the Chinese editorial office has filled in another 70." Person in charge of the pharmaceutical enterprises participating in the meeting Among 120 people, there are also a number of administrative posts, "only about 70 business personnel actually conduct the review" Not only is it difficult to increase the number of personnel limited by the establishment, but also the drug evaluation center is facing the dilemma of personnel loss due to the high pressure of work and the less attractive salary than the industry According to the Southern Weekend reporter, since this year, many reviewers have left the center In the post of drug evaluation, which relies heavily on the ability and quality of reviewers, the contrast between the number of reviewers and nearly 10000 queuing applications is the difficulty recognized by all parties The "fast March" suddenly slowed down for other reasons besides too few people and slow drug review A person in charge of a pharmaceutical enterprise disclosed to the Southern Weekend reporter that two days ago, a leader of the General Administration of food and drug went to his company, and the person in charge specifically asked about the review speed, "from the reply, I think the food and drug administration has felt the pressure, but is willing to be scolded slowly, and is unwilling to make mistakes." "There are many reasons for procrastination, but there may be risks," Miao Baoying, deputy director of Nantong Drug Administration of Jiangsu Province, also told Southern Weekend reporters One of the reasons for the slow approval is the cautious response of some drug registrants under the anti-corruption situation, who believe that "it is safer not to approve or slow approval, but to make mistakes if approved" The State Food and drug administration is responsible for the pre market evaluation of drugs, which has been in China for more than ten years The "Guoyao Zhuzi" drug listing pass was officially issued after the establishment of the drug administration in 2001 At the beginning of its establishment, in order to solve the problem of insufficient supply in the drug market and encourage the development of the industry, the drug evaluation department, with the word "fast" at the head, approved more than 100000 batches in a few years The drug approval rush ended in 2006, when Zheng Xiaoyu, the first director of the State Drug Administration, was investigated Since then, Zheng was sentenced to death for bribery of 6.49 million yuan and dereliction of duty The great leap forward era of drug approval in China ended On the same day that Zheng Xiaoyu was executed, the government issued a new version of the measures for the administration of drug registration, and drug approval entered the "slow lane" Although Zheng case has been in the past eight years, its impact on the atmosphere and psychology of drug review institutions can not be ignored "The internal atmosphere is strict." The government affairs director of a Chinese foreign joint venture pharmaceutical company told Southern Weekend reporters According to the report issued by the drug review center of the State Food and drug administration, only 416 drugs were approved for marketing by the drug review center in 2013 In this report, the center for drug review acknowledged that in the past three years, the waiting time for the review of chemical drugs, whether new drugs or generic drugs, has been gradually extended and there is a "backlog" phenomenon However, in the context of the current hot investment in pharmaceutical research and development, nearly 5000 pharmaceutical enterprises are in deep trouble For example, Benxi is the pharmaceutical capital of China and Taizhou is the pharmaceutical city of China Many enterprises have been introduced, but the batch number has not been taken down As a result, many pharmaceutical factories are difficult to survive, land is wasted, and local GDP is also affected Miao Baoying, deputy director of Nantong drug administration, told the Southern Weekend reporter that low efficiency also indirectly increased the economic burden of patients' drug use After the expiration of some foreign patent drugs, there could have been imitated varieties on the market immediately in China, but due to the delay in the review cycle, few of them could be seamlessly connected The slow evaluation also made the drugs developed under the new quality standards unable to be put on the market in time Most of the drugs in circulation were approved in the era of "great leap forward" before 2006 According to Cheng Zengjiang's statistics, 2007-2009 is the recovery period, and there is basically no new drug approval; from 2009-2013, the number of chemical drugs (including new drugs and generic drugs) approved declined in a straight line, with 2663 domestic drug numbers approved in five years, accounting for less than 2% of the total market number of 167000 "Better quality drugs cannot be brought into the market in time, and patients are affected," Cheng said Another reason why urea is crazy behind the sluggish drug approval is the repeated application and the logic of "card quantity" brought by it According to the data in the 2013 annual drug review report published by the drug review center of the State Food and drug administration, taking chemicals (which account for the "big head") as an example, of the more than 2000 new applications in 2013, 1039 drugs have more than 20 approval numbers, accounting for 42.8%, and 38.4% have more than 10 approval numbers Since September this year, its official website has published the catalogue of the first batch of over repeated drug varieties, which for the first time reminds social investors and relevant enterprises to pay attention to the assessment of R & D risks and make prudent investment and operation decisions One of the reasons for the slow review is that a large number of enterprises repeatedly declare and occupy review resources "Too many batches of the same variety, disorderly competition, and market confusion" is also a common industry malady mentioned by officials of drug review departments in their public speeches In this context, the pharmaceutical industry, a DC legend approval department "card number", a variety only approved three or five However, this statement has not been publicly confirmed by the drug administration In Cheng Zengjiang's view, this kind of potential rule is both planned economy and monopoly protection "How many families do we need, we can't take the drug to the general public has the final say, and we must give it to the market for testing." Miao BAOYING tells the story of a crazy urea: the raw material urea is actually refined by using agricultural urea (fertilizer), which has no technological content, only a few steps of technology and limited cost However, due to the slow approval in the past few years, many pharmaceutical companies are still queuing up to apply for the production of urea API The medical urea with API number has actually sold to more than 400000 yuan per ton, which is more than ten times the original market price Some preparations using urea as raw materials, such as urea cream, urea vitamin E cream, etc., have to stop production because they cannot afford the high price raw materials The urea craze continued until the food and Drug Administration approved several new codes However, "the money earned in those years by that unique medical urea plant is only an astronomical figure!" There are a lot of APIs with fewer numbers similar to urea In recent years, some manufacturers even specially purchase these rare documents, and then substantially raise the price of raw materials Miao BAOYING believes that the delayed approval of the drug regulatory authorities has objectively contributed to the chaos of the drug market Drug regulatory departments are determined to adjust the industrial structure through the review baton, but enterprises and markets have their own survival logic Under the realistic background that China is still a big country of generic drugs, the continuous development of new varieties is an important source of profit for pharmaceutical enterprises Ren Wuxian, chairman of Yabao Pharmaceutical Group, told Nanfang Weekend that after the new GMP certification in 2010, the company has increased its investment of 1 billion yuan to transform its production line In addition to the rising costs, it has to constantly report for approval of new varieties to survive, because the gross profit of new products is large Zhu Xun, President of tongjuyi new medicine talent club and member of China drug review expert committee, describes the path that a drug must go through from registration to final arrival at the hands of consumers: Drug Registration - medical insurance directory - Bidding Procurement - hospital procurement - doctor's prescription After layers of control, there is a strange situation in the competition of the drug market: because every link must account for the profits of drugs, people rush to set high prices Unreasonable pricing and bidding mechanism also enable pharmaceutical companies to maintain profits by constantly changing dosage forms and submitting new drugs for approval In this context, the drug evaluation department, whose fundamental responsibility is to ensure the safety and effectiveness of drugs entering the market, is embarrassed Another drawback of the troubles under the gray curtain is the opacity of the evaluation criteria Miao BAOYING told Southern Weekend reporters that at present, drug registration and evaluation departments often revise the rules with red headed documents The non transparency of the evaluation criteria is actually one of the reasons why the enterprises repeat the declaration - because they do not know the criteria, some declaration materials with obvious defects are also queuing up Miao BAOYING said, "many applications should be filtered out as early as the early stage of the audit." "The FDA has a special orange book, which is one