Small and medium-sized pharmaceutical enterprises are embarrassed by the new GMP: unwilling to quit and have no money to reform

2014-01-16 source: rule of law weekend "in order to pass the new GMP certification, we started to prepare from 2011, and did not pass the certification until the first two months." Wang Yu (pseudonym) is a staff member of a pharmaceutical enterprise in Northeast China His main work in the past two years is to be responsible for the certification of the new version of GMP "I come to Beijing almost every month The GMP certification center has gone there more than 10 times Fortunately, I passed the certification before the GMP deadline." Recalling the process of certification, Wang Yu was still haunted With the coming of the new GMP "big test", every pharmaceutical company is nervous GMP is a set of mandatory standards applicable to pharmaceutical, food and other industries, which requires enterprises to meet the requirements of health quality in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control and other aspects in accordance with relevant national laws and regulations In other words, GMP certification is the entry threshold for pharmaceutical enterprises According to the announcement of the State Food and drug administration, as of December 31, 2013, 796 of the 1319 aseptic drug manufacturing enterprises in China have passed the certification in all or part of their workshops, accounting for 60.3% According to the announcement, since January 1, 2014, all sterile drug manufacturers or workshops that failed to pass the GMP certification of the new version of drugs will stop production After the enterprise stops production, if it completes the GMP transformation of the new version, it can continue to apply for certification; the enterprises that give up certification can exit in an orderly manner through independent selection of variety technology transfer, enterprise merger and reorganization, etc "Most of the enterprises that have passed the new GMP certification are large enterprises, but not many small enterprises, because the cost of transformation is not a small number for enterprises," Wang Yu, a high upgrade cost, told reporters Statistics show that in the last round of GMP certification, a total of 3959 production enterprises passed the certification, with a total cost of more than 150 billion yuan, and about 1400 enterprises failed to pass the GMP certification were eliminated The head of the Department of drug safety supervision of the State Food and Drug Administration once said publicly that it is expected that enterprises will meet the new regulations, and only the total hardware investment will need 200 billion to 300 billion yuan Yu Mingde, President of China Pharmaceutical Enterprise Management Association, told reporters: "the new GMP certification requires higher hardware requirements, and sets stricter air purification standards and cleanliness standards for sterile drugs This time, the standard is relatively high, which has reached the level of the European Union, so enterprises need to invest a lot in the transformation of equipment " Guo Fanli, research director of CIC, analyzed: "in view of the newly revised GMP requirements, the enterprise will invest heavily in the new plant, or the transformation of the original drug production plant and air conditioning system If we want to meet the requirements of the new GMP, we need to invest a minimum of 10 million yuan and a high of 100 million yuan " In addition to the high hardware requirements, the new GMP also increases the requirements of risk management system, design confirmation system, post training system, change control system, deviation handling, etc "All of these systems are feasible, but their implementation is quite complicated and requires a relatively long cycle." "This is going to be a relatively concentrated survival of the fittest, and the big companies that are ahead and leading in technology will ultimately benefit," Yu said Yu predicted that 20% to 30% of enterprises would withdraw from the market, especially those small enterprises that could not stand the severe test "The last round of GMP certification was in 2004 It was relatively strict in the early stage, but in the later stage, there was a phenomenon of" draining water " Even so, 25% of pharmaceutical companies are still out of the market The new GMP standard has been greatly improved, and it is more strict in the inspection " Even though Wang Yu's pharmaceutical company has strong financial strength, it still feels more difficult to pass Zhang Wensheng, a lawyer in the pharmaceutical industry, told reporters: "small and medium-sized pharmaceutical enterprises are in a very awkward situation They are neither willing to withdraw from the market nor pay for transformation GMP certification is the entry threshold, and enterprises will try their best to pass the certification Small enterprises want to spend the least money to pass the certification, and the local government will not watch these enterprises die, often make some modifications " Yu Mingde also said that the standards for GMP certification in the last round were indeed tight before and loose after, and there were regional differences: "at present, it seems that the control is relatively strict Now the GMP certification is grasped by Beijing to the end, and the power has not been delegated to the local government, but it is difficult to say whether it will eventually" release water " Small enterprises may take risks to solve the problem of overcapacity, which has been perplexing the pharmaceutical industry for a long time Due to the low access threshold of the old GMP certification, pharmaceutical enterprises are small, disordered and scattered The phenomenon of overcapacity in the sterile drug market is also serious Many pharmaceutical products of the same kind compete fiercely, and the process and technology are not qualified frequently He Quanying, director of the respiratory department of Peking University People's Hospital, once said publicly that in recent years, the incidence of adverse reactions of sterile drugs is very high in clinical practice, which is generally manifested as anaphylaxis In severe cases, shock or even death may occur These adverse events, in addition to the physical factors of individual patients, are closely related to drug quality According to the announcement of the State Food and drug administration, although only 60.3% of sterile drug manufacturers have passed GMP certification, the overall production capacity has reached more than 160% of the actual market demand in 2012, which can meet the market supply The problem of overcapacity is obvious Yu Mingde said that even without the requirements of the new GMP, there are still a number of sterile preparation enterprises facing elimination "In terms of production capacity and utilization rate of Chinese drugs, the powder injection in sterile preparations is the lowest," he said The utilization rate is 27% and the excess rate is 73% It is the dosage form with the largest capacity, the highest excess rate and the lowest utilization rate of production capacity among many types of preparations " Foreign enterprises are committed to independent research and development, and there are not so many manufacturers of the same product, while in China, they are basically generic drugs, and there is no gap in technology, so enterprises can only compete for costs Zhang Wensheng, who has been in the pharmaceutical industry for many years, said: "some small enterprises are desperate under the pressure of competition Some enterprises only have part of their production lines passed the GMP certification and put them into production, and even several enterprises share a drug batch number." "Some small enterprises have become an unstable factor in the drug market, and the vicious competition is serious The new GMP certification makes the enterprises that do not meet the standards withdraw from the market, alleviates the situation of overcapacity, and is conducive to the realization of fair competition," Zhang Wensheng told reporters From 1998 to 2004, the market demand of pharmaceutical equipment in China has been growing rapidly With the end of the last round of GMP certification, the growth rate of the industry has slowed down since 2005 The new version of GMP puts forward higher requirements for hardware and brings red profits to the pharmaceutical equipment industry Truking technology is one of the largest biomedical equipment R & D and manufacturing enterprises in China According to its prospectus, in 2012, it achieved sales revenue including tax of 688 million yuan, sales revenue excluding tax of 588.7 million yuan, a year-on-year increase of 45.52%; operating net profit of 92.74 million yuan, a year-on-year increase of 55.99% In 2012, dongfulong achieved an operating revenue of 820 million yuan, a year-on-year increase of 26.66%, and a net profit of 230 million yuan, a year-on-year increase of 7.33%; Qianshan pharmaceutical realized an operating revenue of 360 million yuan, a year-on-year increase of 38.25%, and a net profit of 71.2134 million yuan, a year-on-year increase of 38.14% Zhao Lin, Deputy Secretary General of China Pharmaceutical Equipment Association, told the reporter at the weekend of rule of law: "the first step for a pharmaceutical factory to carry out GMP certification is to carry out transformation The transformation is multifaceted, and the software and hardware must be transformed Hardware includes the transformation of plant and equipment During the transformation period, the sales momentum of equipment enterprises will be very good, and the sales volume of enterprises will be greatly increased " Zhao Lin recalled: "the last round of GMP certification was in 2004, which was also the peak year of sales in our pharmaceutical equipment industry But after 2004, the whole industry entered a low point After passing the certification, it is very difficult for enterprises to carry out large investment transformation in three to five years." "The new GMP certification is more strict Many enterprises can't fool, but actually buy good equipment." Zhao Lin thinks that for the pharmaceutical equipment industry, this is good on the whole "The increase of market demand also attracts the inflow of capital, technology and personnel Some edge enterprises transfer to the pharmaceutical equipment during the GMP certification period, such as chemical enterprises, health products enterprises, etc." President Yu Mingde thinks that the pharmaceutical equipment industry may not usher in the spring: "compared with foreign countries, there is still a big gap in the pharmaceutical equipment industry in China For example, the equipment technology in foreign countries is relatively mature, and the whole production line is provided Many pharmaceutical companies will choose to buy foreign equipment, which is a challenge to the domestic pharmaceutical equipment industry."