China will promote the transformation and upgrading of the pharmaceutical industry

Recently, china's pharmaceutical industry brewing new reforms, including raising the standard of drug evaluation Click on the picture into the next page of China's will to promote the transformation of the pharmaceutical industry upgrade August 18, the long-awaited review and approval of drug medical device severance of the system, finally in the form of a State Council document The official interpretation and interviewed experts at the press conference said that the reform is not a simple "headache and pain", in addition to accelerating the solution of the application has been criticized a large backlog of applications, reform also pay attention to improve drug review standards, to achieve drug safety, efficiency, quality control, to promote the of China's pharmaceutical industry restructuring and transformation upgrading new drug concept to change before, China's new drug identification standards are relatively broad, as long as not listed in China can be, listed drugs to add new adaptation certificate, change acid root, base, and even only change the dosage type of drugs can be identified as new drugs After the reform, only drugs that are not listed and sold in China or abroad can be recognized as new drugs, and on this basis, according to the originality and novelty of the material basis, the new drugs are divided into innovative drugs and improved new drugs Wu Wei, deputy director of the State Administration of Food and Drug Administration, who , said that although not listed in China but has been listed abroad for many years, it is not reasonable to enter the Chinese market as a new drug approval, "the concept of new drugs to change, into a truly meaningful innovative products." Some experts on this evaluation, from the international perspective, after the reform of China's new drug identification standards will be in a relatively strict level, "the threshold is indeed high, there will be a lot of new drug registration applications are blocked out, will certainly speed up the pace of approval of new drugs." But some experts say that for China's developing pharmaceutical industry, if the standards for new drug identification are too strict, it will dampen a certain degree of enthusiasm imitation of existing national standards is low-level imitation, and low imitation threshold will cause a large number of double declaration phenomenon, the future generic drugs must be "consistent with the quality and efficacy of the original drug." Wu Wei, of the , said that China's current backlog of about 21,000 drug review and approval applications, most of which are generic applications, the repetition rate is very high, "a total of 168,000 drug approval number, and the listed products sold only involved more than 50,000, two-thirds of the approval in sleep; Low-level generic duplicate applications take up limited review resources, while approved products do not have much market value The quality of generic drugs should be raised
the new application for review and approval of generic drugs in the future, the original research drug as the reference preparation, to ensure the quality and efficacy of newly approved generic drugs consistency So what about approved generics? Wu said that as a huge project to improve the overall level of chinese generic drugs, it is imperative to carry out the consistent evaluation of the quality of listed generic drugs Wu Wei introduced, the quality consistency evaluation of generic drugs first of all to clarify the reference preparations and evaluation methods, encourage enterprises to actively look for the original research drugs or internationally recognized drugs for comparison; 　　"First of all, the subject of consistent evaluation is the enterprise, to carry out this work must improve the consciousness and enthusiasm of enterprises Wu said that through the quality consistency evaluation of generic drugs can be identified as an alternative to the original research drugs, should be in the drug tender procurement, into the medical insurance catalog process to obtain a certain advantage conditions, "who do this thing who benefits", to meet the interests of generic drug enterprises certain reform clear, the deadline can not complete the quality of consistency evaluation of generic drugs will not be re-registered, which for some generic manufacturers, may be a "life and death." Chang Feng, director of the business laboratory of the International Pharmaceutical Business School of China Pharmaceutical University, believes that in the short term, domestic generic drug manufacturers may experience a period of pain, but in the long run, all domestic generic drugs after a round of "transformation", will certainly improve the quality and effectiveness of drugs as a whole; Wu Wei said that the quality of consistency evaluation will inevitably increase the production costs of enterprises, the quality of generic drugs after the price is also improved is understandable, "but the price increase will not be very large, should be controlled in an acceptable degree, compared to the original research drugs will maintain a strong competitive advantage." The introduction of innovative drugs to be fast multinational pharmaceutical companies to enter China, there will be a lag period of several years, for many diseases of special effects of new drugs are not sold in the country, there have been voices questioning this to a certain extent limit the benefits of chinese people enjoy scientific and technological progress Wu Wei said that countries have different policies for the introduction of innovative drugs, because each drug will produce different reactions in different species, China's laws and regulations and existing policies are the starting point to protect the lives and interests of citizens With the rapid development of China's economy, the public's health needs are also rising rapidly, the desire to get innovative drugs is becoming more and more urgent The reform proposal proposes to allow overseas unlisted new drugs to be conducted simultaneously in China after approval, to encourage domestic clinical trial institutions to participate in international multi-center clinical trials, and to meet the requirements of experimental data can be used in registration applications "This is a huge reform, which means that innovative drugs can be tested simultaneously at home and abroad This could greatly shorten the experimental time of innovative drugs and speed up imports, Mr Wu said experts said that the State Council approved the document to give foreign innovative drugs in the domestic synchronization of clinical trials legal basis, but also to the government departments of the supervision of higher requirements, must strengthen the clinical trials of the subject's life and ethical safety protection