December 31, 2013 is the deadline for the "Good Manufacturing Practice for Pharmaceuticals" (hereinafter referred to as the "new version of GMP") for sterile drugs such as blood products, vaccines, and injections in my country. According to data on December 23, 2013, 597 sterile drug manufacturers have passed the new GMP certification, accounting for only 45.3 of the total number of sterile drug manufacturers. However, nearly 60% of sterile drug manufacturers have fallen outside the door of the new version of GMP certification, which implies that "customs clearance" enterprises are expected to make great efforts to expand the market in 2014. Even, as the new version of GMP certification continues to advance, the pattern of China's pharmaceutical industry will further change in 2014.
Only 40% of them won the "No Death Card 』
According to the new version of GMP certification schedule, the "certification" door of sterile drug manufacturers such as blood products, vaccines and injections has been quietly closed. According to the data at the end of June 2013, only 329 of the 1319 sterile drug manufacturers in the country have partially or fully passed the new GMP certification, accounting for 24.9 percent of the total. However, by the end of September 2013, the national pass rate of sterile drug manufacturers was only 29.7. As of December 23, 2013, 597 sterile drug manufacturers had passed the new GMP certification, accounting for only 45.3 of the total number of sterile drug manufacturers. Judging from the published data, the new GMP certification in 2013 is not only unsatisfactory, but also slow.
In fact, the former State Food and Drug Administration has already organized a large-scale investigation of drug manufacturers, and it is expected that 96 sterile drug manufacturers will abandon the reform. According to Li Guoqing, director of the Safety Supervision Department of the State Food and Drug Administration at that time, among different dosage forms of pharmaceutical companies, the proportion of sterile drug companies withdrawing from the market will be the highest. And now it seems that the actual number of phase-outs may be as high as 50%.
At the same time, there are many listed companies in the nearly half of the pharmaceutical companies that have not passed the new GMP certification.
On December 18, 2013, the first listed pharmaceutical company Ziguangguhan Group Co., Ltd. issued an announcement stating that its wholly-owned subsidiary Hengyang Pharmaceutical Co., Ltd. began to stop at the end of December 2013 due to the expiration of the GMP certificate for the injection production line. The production of injection products is expected to resume production after obtaining certification in 2015.
Coincidentally, Shanghai Laishi's plan to purchase all shares of Banghe Biopharmaceutical at a price of 1.8 billion yuan was rejected by the CSRC on the grounds that "there is uncertainty in Banghe Pharmaceutical's obtaining the new GMP certification by the end of 2013. Watson Biology acquired Hebei Da 'an Pharmaceutical in 2013. Its Da 'an production workshop is currently suspended and is undergoing transformation according to the requirements of the new GMP. Watson Biology has not announced whether Da 'an Pharmaceutical has passed the new GMP certification.
In response, yang Tao, a special observer of this newspaper and a pharmaceutical enterprise management consultant of lito management consulting co., ltd., said that the new GMP certification deadline for sterile drug manufacturers has passed, and the overall situation is not ideal. the number of pharmaceutical enterprises that have passed the certification is less than half of the total number of pharmaceutical enterprises in the industry, and the 45.3 percent passing rate also includes those pharmaceutical enterprises that have passed the certification in a single workshop in order to seize the time.
Although the pass rate is asymmetrical with the expectations of relevant national departments, the production capacity of most sterile drug manufacturers that have passed the new version of GMP has been greatly improved. Even if the deadline has passed, all companies that have not passed the certification will stop production. The production capacity of certified enterprises can still meet market needs.
Certification but no bidding
When analyzing the reasons for the low pass rate, Yang Tao said that it was mainly caused by the company's abandonment of its own operating conditions and future market expectations.
When the new version of GMP was first introduced, it was demonized by many "authoritative experts" and misled many pharmaceutical companies. But in fact, as long as enterprises carefully understand the new version of GMP, they will find that the software requirements of the new version of GMP far exceed the hardware requirements. However, for enterprises with poor management and poor market expectations, it is really stressful to concentrate a large amount of funds on the transformation of the new version of GMP.
In addition to the above reasons, the enthusiasm of enterprises for the new version of GMP certification is also one of the reasons for its low pass rate. Although it is imperative for the country to promote the new version of GMP certification, enterprises are limited by their own development and weak strength, which makes each enterprise have different attitudes towards the new version of GMP certification. According to the existing certification situation, it can be seen that the enterprises that are actively reforming the new version of GMP are often concentrated in several types. One is the enterprises that are currently operating well and have good expectations in the future; the other is that the current strength is average, but they have good varieties and good expectations in the future. The third is a strong listed company; the fourth is a comprehensive enterprise that uses the license of a pharmaceutical company to serve its main business.
At the same time, relevant departments have also requested that the new version of GMP certification should not be "tight before and loose after". In order to implement the new version of GMP certification, some provinces and cities have made it clear during drug bidding that they will adopt the principle of quality stratification. Drugs participating in the bidding will be reviewed according to the quality levels of GMP certified drugs and non-GMP drugs, so as to improve drug quality and promote the implementation of GMP. Shandong and Qinghai have adopted a one-vote veto system for enterprises that have not passed the new GMP certification when bidding for basic drugs. In such a policy environment, companies that have not successfully passed the new version of GMP certification will undoubtedly give themselves a big question mark if they want to find another way to seek the basic drug market.
"If sterile drug manufacturers fail to pass the new GMP certification, they will definitely withdraw from the new drug bidding in 2014; If they have not passed the new GMP certification by January 1, 2014, they will not be able to continue production even if they apply for delayed certification. Although the stock products snatched before this can continue to be sold until the validity period, according to the bidding market, the bidding agency will never risk letting an enterprise that has not passed the new GMP enter the bid. If it is allowed to win the bid, but there is no production right in the future, it will lead to insufficient supply of products. At the same time, it will be difficult to appease the enterprises that have passed the new GMP certification, and the fairness of the market will no longer exist. Therefore, the bidding agency will never shoot itself in the foot." Yang Tao said so.
Industry shuffle or acceleration
In addition to sterile drug manufacturers, the new version of GMP also stipulates that other drug manufacturers must pass the certification by the end of 2015, otherwise they will not escape the bad luck of stopping production. For the remaining two-year transition period, 2014 will surely become a large-scale new GMP transformation start-up year.
Yang Tao pointed out that based on the experience of the first version of GMP certification, the sooner the enterprise successfully passes the certification, the more advantageous it will be in sales bidding. Even if the enterprises that have not passed the new GMP certification expand their production before the deadline expires, they can pre-store products for several quarters and maintain supply for a period of time, so that the sales performance of the enterprises that have passed the GMP certification will not increase explosively in the short term. However, from the perspective of the flexibility of the pharmaceutical market in 2014, the obvious benefits will be the relatively low-end varieties in the injection field, such as Kelun Pharmaceutical, China Resources Shuanghe and other antibiotic injection companies will have a higher market concentration, and their growth rate It will also be gradually released, which is good for companies that have passed the new GMP certification. Therefore, as long as there is a certain strength or ability of enterprises will be the fastest speed to implement the new version of GMP transformation, will not wait and see attitude to apply for extension in 2015.
In addition, there are a large number of pharmaceutical production enterprises in China, and the situation of overcapacity in pharmaceutical production is more prominent. Taking freeze-dried powder injection in sterile drug manufacturers as an example, less than 20% of the enterprises that have passed the new GMP certification can supply nearly 70% of the market demand, which fully illustrates the problems existing in the structure and production capacity of China's pharmaceutical industry.
In addition, for some enterprises at or below the survival line, they are unable to carry out the new GMP transformation due to lack of funds, or are unable to independently develop new products and carry out market expansion and channel network construction due to weak strength. Before the deadline of the new GMP certification, in order to revitalize the aged assets, they have adopted methods such as selling the document number and changing the land to obtain the land bonus of industrial land to commercial land. At the same time, enterprises above the survival line also want to take this opportunity to "rob by fire" to achieve industrial layout, document number collection and storage, etc. In the case of the same needs of both sides, China's pharmaceutical industry in 2014 is bound to appear large-scale mergers and acquisitions.
At the same time, Yang Tao further pointed out that the government should reduce administrative intervention in the future merger and reorganization of enterprises that have passed the new version of GMP certification. China's corresponding laws and regulations are not perfect, lack of serious criticism is only the foundation, and can not really achieve the law must be strictly in accordance with the law is the fatal injury. For my country's pharmaceutical industry, the phenomenon of bad money driving out good money is widespread, and counterfeit drug incidents continue to occur, which are all caused by the inaction of the drug supervision system.
In this context, for enterprises that have passed the new version of GMP certification, what is needed is not the support and subsidies given by the government from the policy level, but strict regulatory measures and incentives. At the same time, for enterprises that have passed the new version of GMP certification, giving extra points in drug bidding and procurement is the greatest support. Only by re-establishing the confidence of Chinese people in China's food and drugs can the credibility of the government last forever.