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    Home > Active Ingredient News > Drugs Articles > Generic pharmaceutical companies are facing new rules of the game and new opportunities for development

    Generic pharmaceutical companies are facing new rules of the game and new opportunities for development

    • Last Update: 2016-01-22
    • Source: Internet
    • Author: User
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    Source: Sina Finance and Economics on January 22, 2016, China is a big country of generic drugs, but in terms of quality, process and auxiliary materials, it is often difficult to attract people's attention on the international stage due to poor skills Two thousand and fifteen In, the State Food and Drug Administration successively issued the opinions on carrying out quality and efficacy consistency evaluation of generic drugs (Draft for comments) and the announcement on carrying out self inspection and verification of clinical trial data of drugs to ensure the safety and effectiveness of drugs from the source, so that the home-made generic drugs commonly talked about by the elderly will usher in a new change and the market will undergo a major reshuffle, The enterprises of fishing in troubled waters will be shuffled out, "bad money will no longer drive out good money", which will bring benefits to high-quality innovative enterprises with R & D strength, and also enable people to use reassuring drugs Generic pharmaceutical enterprises will face new rules of the game The so-called generic drug refers to a kind of generic product which is the same as the commodity drug in terms of dosage, safety, efficacy, quality, effect and indication At present, of the nearly 170000 drug approval documents in China, 122000 are chemical drugs, and more than 95% are generic drugs In 2007, the State Food and Drug Administration promulgated the measures for the administration of drug registration, which brought a shock and became a watershed in the industry Because before that, it was relatively easy for pharmaceutical enterprises to get approval documents, and some of them could get dozens or even hundreds of them in one year Before 2000, the drug review and approval were in the charge of the drug regulatory departments of each province, and the different standards had hidden dangers for the good and the bad of Chinese generic drugs In 2015, the State Food and Drug Administration issued the opinions on the evaluation of the consistency of quality and efficacy of generic drugs (Draft for comments), which also proposed that for the evaluation object in 2007: for the generic drugs that have been approved for marketing, if they are not approved in accordance with the principle of consistency with the quality and efficacy of the original research drugs, the consistency evaluation shall be carried out in accordance with the above principles For the chemical generic oral solid preparations in the National Essential Drug Catalogue (2012 version) approved before October 1, 2007, the consistency evaluation shall be completed by the end of 2018 If the evaluation fails at that time, the drug approval number shall be cancelled In addition, for other generic drugs approved for marketing before 2007 and those approved for marketing after 2007, if the same product of other manufacturing enterprises fails to pass the evaluation within 3 years after the first product passes the consistency evaluation, the approval number of the drug shall be cancelled Jin Fang, member of the national pharmacopoeia committee, pointed out that in theory, generic drugs should be the same as the original drugs, so that they can become generic drugs However, from the perspective of the development of pharmaceutical industry for so many years in China, generic drugs in the early stage of R & D, especially 5-10 The evaluation technology of generic drugs developed years ago has not reached the current standard and requirement, so there are some defects in the evaluation technology When conducting clinical research, the authenticity of data and whether the clinical research is standardized will also lead to the quality of generic drugs approved for marketing will be different from that of the original drugs, leading to differences in their clinical efficacy Jin Fang said: consistency evaluation opinions bring new requirements to pharmaceutical enterprises First, we need to conduct a comprehensive research and understanding of the original research drug to set the quality and quality of the drug to be copied, which also means that the enterprise's standards may need to be re formulated to truly achieve the consistency of clinical efficacy and international drug quality The market will undergo a big reshuffle According to the supporting reward and punishment measures for the conformity evaluation of generic drugs published by the State Food and drug administration, the encouraging measures include: first, the supplementary application for the enterprise to change the prescription and process, and the General Administration establishes a unified evaluation channel, which will be reviewed together; second, the varieties that pass the evaluation will be published by the general administration to the society, clearly marked in the drug instructions and labels, and enterprises are allowed to declare drugs The third is that the health and Family Planning Commission will give priority to the use of drugs in bidding and purchasing, and the Ministry of human resources and social security will give priority to the inclusion in the medical insurance reimbursement catalog; the fourth is that the Ministry of industry and information technology will give support to the technical transformation of enterprises On the contrary, the disciplinary measures are very strict First, by 2018, if the varieties of the chemical generic oral solid preparations in the national essential drug catalogue fail to pass the evaluation, they shall not be listed; second, other varieties, after the evaluation of the surrendered varieties, the other same varieties are in 3 Those failing to pass the evaluation within the year shall not be listed; third, those failing to pass the evaluation at the expiration of the validity period of the drug approval number shall be cancelled; fourth, those failing to pass the evaluation with more than three identical varieties shall not be selected in terms of bidding procurement, medical insurance reimbursement, etc "If there is no access to bidding procurement, it means that the most critical sales channels of drugs will be cut off, and the deterrent force to enterprises is quite large." A medical insider told reporters Tao Jianhong, deputy director of the South Institute of pharmaceutical economics of the State Food and drug administration, predicted that domestic generic drugs would face a major reshuffle In fact, only the high standard, strict quality standard and scientific and rigorous evaluation system can motivate the enterprise's in-depth and meticulous research and development and good standard production Because only when the product fails to pass the inspection according to the requirements, can the enterprise know where the gap is and where the direction of efforts is Great Wall Securities Research Report also believes that drug review reform such as generic drug consistency evaluation will purify the entire drug approval environment While benefiting the leading pharmaceutical enterprises with R & D strength, a number of small and medium-sized pharmaceutical enterprises may face merger and elimination in the drug review reform, and a new round of integration wave in the pharmaceutical industry will hit The innovative pharmaceutical enterprises welcome the new opportunity of development and talk about the reform of drug review and approval and the measures to strengthen supervision We have to mention the announcement on carrying out the self inspection and verification of drug clinical trial data issued by the State Food and Drug Administration in 2015, that is, launching the self inspection and verification of drug clinical trial data in an all-round way, involving 1622 received by the general administration before July 22, 2015 There are 948 new drugs, 503 generic drugs and 171 imported drugs According to the data, as of December 14, 2015, the total number of applications for voluntary withdrawal of drug registration was 727 Wu Zhen, deputy director of the State Food and drug administration, previously publicly said that the persistent disease of repeated declaration and registration of drugs on the one hand reflected the enthusiasm of enterprises in production, but on the other hand, it also showed that there were components of fraud in drug declaration, among which the low-level duplication of generic drugs was obvious "The door that allows the enterprise to withdraw voluntarily is always open If the passive finder is dealt with seriously, not only the responsible person shall be investigated and blacklisted, the applicant shall not apply within three years, but also all the accepted ones shall be returned, and the previous ones shall be traced." Wu Zhen said Market participants expect that, after the deadline is clear, in the short term, the improvement of drug R & D and evaluation standards will have a certain negative impact on the industry In the long term, it will greatly improve the standardization of R & D and production of generic drugs, and improve the overall quality level of generic drugs For example, the standardized large-scale generic pharmaceutical enterprises are expected to benefit from the transformation and integration of the industry, and the policy of generic drug consistency evaluation will also benefit the standardized cro leading enterprises for a long time For the whole industry, "bad currency will not expel good currency" will bring about the improvement of industry concentration It is expected that the subsequent supporting policies will be launched one after another, and the implementation effect is worthy of expectation It will also have a profound impact on the competition pattern of the industry As a high-tech pharmaceutical enterprise that can research, produce and sell a series of targeted drugs in China, Ted pharmaceutical will usher in new opportunities for innovation and development At present, the pharmaceutical products of Ted mainly include alprostadil injection, the domestic exclusive nonsteroidal analgesic drug flurbiprofen axetil injection, flurbiprofen cataplasm and so on After the implementation of "construction of technical system for research and development of alprostadil injection drugs", Ted has built a talent team covering clinical medicine, pharmaceutics, pharmacology, pharmacy, chemistry and other disciplines, with the combination of drug research and development, pilot scale-up and production "Clearly put forward to speed up the review of new drugs is a great advantage for new drug R & D enterprises." Analysts pointed out that to open up a green channel for innovative drugs, so that some new drugs urgently needed by the common people can be put into the market quickly, accelerate the use of advanced technology, innovative treatment means, and clinical urgent drug registration applications with obvious treatment advantages, will further promote the transformation and upgrading of the pharmaceutical industry  
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