Multi-sector efforts to promote the reform of the drug equipment review system

Wu Wei, deputy director of the General Administration of Medicines and Medicines, pointed out
that there are many problems in the approval of the of the of medical equipment medicines, mainly manifested in the low quality of registration application data, the review and process needs to be supplemented and perfected many times, seriously affecting the evaluation and approval efficiency
;　　The Opinion clearly states that the definition of a new drug will be adjusted from the current "drugs not listed for sale in China" to "drugs not sold within or outside China" Encourage clinical value-oriented drug innovation, optimize the review and approval process for innovative drugs, and accelerate the review of innovative drugs that are urgently needed in the clinic To carry out a pilot system for drug licensing holders This greatly raises the bar and standards for new drug approvals, crowding out some simple innovations.　　Wu pointed out that the General Administration of Food and Medicine, as the main department of , will speed up the approval of innovative drugs, the implementation of a special review and approval system for innovative drugs Of course, it is also conditional to expedite the review and approval of clinically urgently needed new drugs "Opinion" pointed out that the application for registration of new drugs enterprises need to commit to the price of its products listed in China for sale is not higher than the country of origin or China's surrounding comparable market prices.　　In addition to encouraging drug innovation, the fastest-growing medical device
sindevices in the domestic pharmaceutical industry has also opened up a green channel for the General Administration of Medicine.　　According to Wang Qixiong, Director of the Equipment Registration Department of the General Administration of Medicines, innovative medical devices are currently subject to a special approval process that is prioritized, and special approval channels are given to products that meet several conditions First, the applicant has the invention patent of the core technology of the product in China, the second is the principle or mechanism of action of the relevant product is the first in China, the safety or effectiveness of the product has significant advantages compared with the related products, or has a fundamental improvement, especially with significant clinical use value, and the third is that the products developed have been basically stereotyped.　　By the end of July this year, the General Administration of Food and Drug Administration had reviewed 186 applications for innovative medical devices, identified 33 products that met the scope of innovation, and 10 products have entered the review process.　　Encouraging the price benefit of enterprises to improve the quality of generic drugs "to improve the quality of drugs, will certainly increase costs, drug prices will rise accordingly, prices and quality are matched Wu said that the State Council document has clearly improved the quality of generic drugs, speed up the quality of generic drugs consistency evaluation, and strive to complete by the end of 2018 the national basic drugs oral preparations and reference preparations quality consistency evaluation.　　At present, most of the drugs of domestic pharmaceutical companies are mainly generic drugs, which is also a long-term situation in China's pharmaceutical industry in the future Since 2012, the General Administration of Pharmaceuticals has been conducting a consistent evaluation of generic drugs, that is, requiring generic sand and primary drugs to achieve consistent quality and efficacy, to ensure the safety of people's drug use "This is actually an action plan for the overall level of generics, a huge project Wu said that the need to play the initiative of enterprises, can not be the government hot to do things.　　He believes that the consistency evaluation of generic drugs will certainly increase the cost of enterprises, many enterprises may not want to do, but as a regulatory departments must adhere to the "who works, who benefits" principle, otherwise it can not mobilize the enthusiasm of enterprises "As long as drug prices rise within a reasonable range and publicly acceptable level, the profit margins of the business are appropriate, and I think you can understand that." Wu said.　　An industry insider told the Economic Reference Daily reporter that the General Administration of Food and Drug is only responsible for drug approval and drug quality and safety issues, but has no right to interfere with drug prices, drug bidding and other links The State Council issued a letter, is hoping to coordinate the work of various departments, the Health and Planning Commission, the National Development and Reform Commission and other relevant departments to fully cooperate, to ensure that the "Opinion" can be put in place, and effectively mobilize the enthusiasm of relevant stakeholders.　　Guotai Junan Research reported that the drug registration reform policy frequently introduced, in the face of more stringent drug quality supervision, high-quality listed companies generally have a strong quality management system , or will benefit from industry norms as a whole.　　Severepunishment clinical data to make false drug enterprises out of the "General Administration of Food and Drug check the closure time unchanged - August 25 at 24 o'clock, after no longer accept any form of filing information Wu pointed out that carrying out self-examination and verification of drug clinical trial data is an important part of the implementation of the State Council's deployment by the General Administration of Food and Drug, reform drug review and approval system "combined fist", but there are still some enterprises with a lucky mentality and wait-and-see mentality.　　The Opinion proposes that the application for registration shall be seriously investigated for fraud Strengthen the supervision of clinical trials throughout the process to ensure that clinical trial data are authentic and reliable In the registration application, if there are false research methods, quality standards, pharmacological and toxicology test data, clinical trial results, etc., the applicant and the research institution shall not approve the application for registration of medical devices of drugs, and shall be revoked;　　"The problems in drug clinical trials are more serious, unreliable, untrue and deceptive, which have seriously affected the normal conduct of drug review and approval, and seriously interfered with the effective and safe scientific evaluation of drugs on the market." Wu said that all registered applicants for drugs that have been declared and pending trial at the General Administration of Medicines to ensure that clinical trial data are true and reliable and that relevant evidence is kept intact By August 25, the applicant shall submit an electronic self-examination report and a commitment to the authenticity of the signature of the legal representative on the varieties listed in the annex.　　With only a week to go until August 25th, many drug companies are in a hurry like ants on a hot pot.　　"We don't give interviews and don't want to talk about it "A pharmaceutical company boss told the Economic Reference Daily reporter, I do not know whether this time the General Administration of Medicine to play real.　　"Fortunately, we only have one product that is required to self-check, or really don't know what to do The boss of a state-owned company says the drug companies that have declared a large number of cases have a headache this time.　　Wu said that for the registration application, which does not submit the self-examination report before August 25, and does not voluntarily withdraw the registration application, the General Administration of Food and Drug administration will return its application and publish the list of these varieties and enterprises;　　It is reported that the General Administration of Food and Drug inspection found that clinical trial data is found to have problems with the authenticity of the relevant applicants, within three years will not accept their applications Blacklisting fraudulent applicants, clinical trial institutions, contract research organizations and relevant responsible persons The data on clinical trials in which the person directly responsible for fraud participates in the research or organizes the study shall not be accepted for 10 years.　　A listed pharmaceutical company boss said that the General Administration of Food and Drug administration severely punish clinical data fraud can clear the pharmaceutical industry, purify the environment, so that solid research and development enterprises stand out, for those who declare dozens of pieces a year, advertising innovative pharmaceutical companies is a devastating blow.