Chinese pharmaceutical enterprises usher in the elimination of "accelerator"

Source: e pharmaceutical manager 2018-06-08: China pharmaceutical regulatory bureau was officially elected as a member of the ICH Committee, which is a major event and also good for the development of the whole Chinese pharmaceutical industry However, if you carefully calculate and place it in the current pharmaceutical industry, it will be an accelerator for shuffling and elimination! On June 7, the State Food and Drug Administration announced that at 1:30 p.m local time on June 7, at the first meeting of the International Conference for the technical coordination of human drug registration (ICH) held in Kobe, Japan, the State Drug Administration of China was elected as a member of the ICH management committee In June last year, at the ICH conference held in Montreal, Canada, CFDA was officially approved as the eighth member of the global regulatory body This is a milestone for China's pharmaceutical industry and regulatory level Milestone significance has a huge impact on the pharmaceutical industry, but what kind of impact will it bring to the Chinese pharmaceutical industry? Dr Huang conghai, a well-known pharmaceutical industry figure, believes that to join ICH is just like China's accession to the WTO in that year, so is its historical significance and contribution It was an important time for China's overall reform to advocate its accession to the WTO, but reform in many areas was quite difficult, so even if some of its interests would go out, it would have to join at that time As the politicians at that time said, "reform, if you can't, let the outside change." The same is true for today's pharmaceutical industry 1 The market of generic drugs will be accelerated In fact, for China's pharmaceutical industry, in the past few years, the supply side reform has played a very small role in the pharmaceutical industry The two vote system promoted the concentration of the circulation field and accelerated the elimination of pharmaceutical commercial companies For the reform of the pharmaceutical industry, though several rounds of GMP adjustments have been made, there are still more than 4000 pharmaceutical companies, and the "process verification" which was originally expected to be very promising is expected It has further improved the concentration, but it has not had a substantive impact The reason is that industrial production involves employment and other issues If it is carried out as vigorously as the "722" clinical verification, the result can be imagined that since the policy cannot be changed, it is necessary to introduce "catfish" through market means to speed up the reshuffle of the pharmaceutical industry Perhaps, in the view of most people, joining ICH is only in the mutual recognition of data at the R & D level and some industrial standards, and the impact on the pharmaceutical industry will not be as alarmist as shuffling But from another perspective, at present, data mutual recognition, the proportion of R & D data of Chinese pharmaceutical companies that can be recognized globally is very small, but the proportion of foreign data that can be recognized in China will be very large And this data mutual recognition, including the innovative drug level, of course, also includes the generic level In the past, due to the quality level problems, low-cost competition was the main way However, with the promotion of the consistency evaluation of generic drugs, many products are realized through process improvement, the cost is greatly increased, and the human cost in China is rising, so the cost of generic drugs enterprises has been very high The generic drugs of Chinese pharmaceutical companies can be sold in Europe and America Facing the rapid growth and huge potential market of China, the generic drugs of other countries can also be sold in the Chinese market So it doesn't matter that joining ich will accelerate the elimination of China's generic drug market From the perspective of market impact, the first products to be impacted are those under research that may become the first imitations in the Chinese market In response, Huang conghai said that if the first copy of a product has been listed in Europe, the United States, Japan and other countries, but the Chinese market has not yet been listed, and Chinese enterprises are in the process of research and development, it is possible for them to quickly enter the Chinese market through the mutual recognition of ICH data, thus seizing the position of the first copy It is worth mentioning that at present, China is also formulating the monopoly period policy of patent challenge varieties If China implements this policy and gives the first imitation varieties a certain monopoly period, then it will be a huge challenge for the local research of "first imitation" varieties For the existing generic drugs, consistency evaluation itself will make some products out of the market This round of shuffling is on the way For small enterprises that have no advantage in the past, it is inevitable to eliminate them On the other hand, in the face of such a tempting potential market as China, enterprises in ICH member countries and many generic pharmaceutical giants such as TIWA and mylan can quickly introduce products into China based on this As we often say, the cost and market sales problem is not difficult to solve It only needs to be produced in China, or in regions with lower costs, and reach sales cooperation with local enterprises, so as to form an advantage of the same competitive cost After all, Bayer's aspirin is still selling well despite its many competitors 2 The United States, the European Union and Japan have mature and perfect drug regulatory system and pharmaceutical industry The ICH, which is led by them, has long coordinated technical specifications on drug quality, safety and effectiveness around the world, and promoted the rationalization and consistency of technical requirements for drug registration It has become the highest rule making mechanism for international drug registration technology These standards have been widely applied by developed countries and accepted by developing countries, including China Some drug regulatory underdeveloped countries even directly accept or approve the evaluation results of ICH member countries Although the official election of CFDA as a member of the ICH management committee marks the recognition of the international community to the reform of drug review and approval of the Chinese government and the Chinese pharmaceutical industry, it also means that the international community is willing to accept Chinese regulatory authorities, pharmaceutical industry and research institutions to join the international top rules and standards formulation process However, it is worth noting that there is still a gap between China's many rules and the requirements of ICH As the FDA itself said, in the next step, it will actively participate in ICH related work, make more Chinese voices in the world, and further promote the transformation and implementation of ICH technical guidelines in China "Transformation and implementation" is undoubtedly the improvement of standards As Huang conghai said, drug review and regulatory thinking should be closer to more stringent international standards, and many rules of the game should be in line with international standards The improvement of standards means that enterprises need to invest In the current industry development, there are still a number of small enterprises Under the pressure of various policies, the profits are quite low Therefore, this round of standard improvement will inevitably bring new industry changes Small enterprises are either acquired or eliminated Therefore, from the perspective of general trend, China's evaluation standards and regulatory system need to be improved, which is a good thing for the development of the industry However, in terms of current standards, there are differences between the standards implemented by China Pharmaceutical Regulatory Commission and ICH, so it is inevitable that China will accelerate the improvement of standards in the future, or even directly raise to the international level Is your family the beneficiary of the sudden improvement of standards? In the short term, for many enterprises, China's accession to ICH may face some challenges and even be eliminated 3 90% of pharmaceutical enterprises have been eliminated At present, there are more than 4000 pharmaceutical enterprises in China According to Huang conghai, although it has been upgraded for several rounds, there are still some problems of small dispersion, which makes supervision more difficult From the perspective of the development of pharmaceutical industry in various countries around the world, the remaining 400 enterprises in China, that is, the current 10% or so, is enough In the past, many rounds of shuffling were done at home, but now it's impossible to wash by itself After several GMP certification improvements, China's GMP standard has been in line with international standards However, the competition among enterprises is still disordered, so it is necessary to open up the dyke between Chinese pharmaceutical enterprises and the market, let global competitors enter, help the Chinese market to shuffle and improve the concentration Huang conghai's R & D background, in his opinion, although it has caused some pressure on Chinese enterprises, it is very beneficial in the long run First, at the product R & D level, it can be shared with overseas data and markets, which can realize the globalization of Chinese products; second, there are times differences in the technology of Chinese preparations before, but with the promotion of consistency evaluation and new drug R & D, it will accelerate the elimination of differences, and it will be more convenient to go out under the same rules of the game In addition, Huang also pointed out that no matter the enterprises or practitioners, only those who fight with first-class experts and PK with real guns can get exercise and promotion Maybe they rush to 100 enterprises, 90% of them die, but the remaining 10% succeed, and Chinese pharmaceutical enterprises can develop in the global market In other words, 90% of the dead are the enterprises that should be eliminated When China joins the ICH, it is inevitable that the local pharmaceutical enterprises will be impacted, and they should also be prepared for the impact In fact, as far as the development of China's pharmaceutical industry is concerned, the Drug Administration for drug review and approval has basically straightened out First, the technical standards have started to be in line with the international standards; second, in this round of drug review reform, the industry has developed a sense of meeting the international standards From the perspective of domestic market development, China's consumption demand for pharmaceutical products is also upgrading Upgrading can be divided into two aspects: first, more innovative products will be put on the market to replace backward products; second, the upgrading of technology and quality will be carried out on the basis of existing drugs Therefore, no matter what level, the requirement for the entire pharmaceutical industry is transformation and upgrading Only by upgrading its competitiveness in advance, can it not be eliminated Of course, it should be noted that data mutual recognition is not unconditional, but conditional At present, the guiding principles of ICH need to be further transformed to leave a buffer period for Chinese pharmaceutical enterprises to upgrade For the regulatory level, Huang conghai said that it was "actively participating and orderly promoting".