Six key points on the reform of the examination and approval system of medical devices

Source: insight database 2015-08-18 at 10 a.m., the State Council Office held a press conference, CFDA introduced the reform of the review and approval system of medical devices, and answered questions from reporters What did the press conference say? Point 1 how many drug reviews are overstocked? What's the reason? How to solve the problem of drug review backlog? A total of 21000 drugs are being reviewed by the national drug review center There are many reasons for the backlog: 1 Historical reasons: 17000, 27000 and 21000 drug declarations have been overstocked since 2005, 2008 and 2011 2 Of the 21000 repeated applications, 90% are chemical and generic drugs, and the imitation standard is still the existing national standard Of the 168000 approval numbers, only 2 / 3 are sold on the market, and repeated declaration takes up limited review resources 3 Incomplete application materials, incomplete and non-standard application materials of untrue enterprises lead to the failure of evaluation, and the supplement of application materials also takes a lot of time There are still untruths in the application materials, so the purpose of checking the clinical experiment data before is to crack down on and find out the fraud in the clinical experiment 4 The number of reviewers is less than 120 in China's drug review centers, and 8000 reviews are solved each year In the United States, 5000 reviews are conducted for chemical drugs alone, and 3000 reviews are conducted each year 5 System mechanism and other factors, such as system mechanism, binding of production approval documents and document numbers, etc Accordingly, there are three reform countermeasures: 1 Improve the quality of drug evaluation, improve the quality standard of generic drugs to the original research drug 2 Crack down on fraud 3 Speed up the evaluation, and then the enterprise can only supplement the application data once, and then make the conclusion of approval or disapproval 4 Article 10 of "Reform Opinions" of reviewers shall be increased by means of secondment of personnel from scientific research institutions, institutions of higher learning and purchase of services: implement the main responsibility of the applicant The registration application specification shall be formulated in accordance with the international general rules, and the applicant shall apply in strict accordance with the specified conditions and relevant technical requirements The drug registration applications accepted by the provincial food and Drug Administration and reviewed and approved by the food and drug administration shall be adjusted to the centralized online acceptance by the food and drug administration For the registration application that does not meet the specified conditions and relevant technical requirements, the food and drug administration shall inform the applicant of the content to be supplemented at one time After entering the technical review procedure, except for the registration application of new drugs and first generic drugs, in principle, the applicant is no longer required to supplement information, and only makes the decision of approval or disapproval Point 2 vigorously promote the evaluation of generic drug consistency, what impact will it have on the prices of related drugs? How to mobilize the enthusiasm of enterprises? 1 How to find yuanyan? Enterprises are encouraged to look for the original research institute If they can't find it, they are encouraged to go back to seek the second place and find the internationally recognized international advanced product 2 How to do consistency evaluation? If the dissolution curve in vitro is the same as that in the original study, it is considered to be equivalent in vivo If there is no condition for dissolution in vitro, bioequivalence test must be done 3 How long will it take? In the first batch, the conformity evaluation of the products specified in the essential drug Catalog shall be completed before 2018; in the second batch, the conformity evaluation shall be carried out for the products beyond the essential drug catalog for 8 or 10 years 4 Will the price increase? After the quality of generic drugs is improved, it is normal for the price to be improved, but the competition of generic drugs is fierce and the range will not be too large, and the improvement of price and quality is matched Article 7 of the Reform Opinions: promote the quality consistency evaluation of generic drugs For the generic drugs that have been approved for marketing, according to the principle of consistency with the quality and efficacy of the original drugs, the quality consistency evaluation shall be carried out by stages and batches Drug manufacturers shall evaluate the quality consistency of their products with reference preparations in accordance with the prescribed methods and submit the evaluation results to the food and drug administration The reference preparation shall be determined by the food and drug administration after consultation with experts The original drug or the internationally recognized same kind of drug may be selected If there is no reference preparation, the drug manufacturer shall conduct clinical effectiveness test Generic drugs that fail to pass the quality consistency evaluation within the specified period shall not be registered again; those that pass the quality consistency evaluation shall be allowed to be marked on the instructions and labels, and shall be supported in clinical application, bidding procurement, medical insurance reimbursement, etc In the process of quality conformity assessment, if the approved process needs to be changed, a supplementary application shall be made in accordance with the relevant provisions of the measures for the administration of drug registration, and the food and drug administration shall set up a green channel to speed up the review and approval The quality consistency evaluation was first carried out in the generic drugs approved for listing before the implementation of the drug registration management measures revised in 2007 In the national pharmacopoeia, the name of the enterprise drafting the drug standard shall be marked to encourage the enterprise to improve the standard and quality of the drugs on the market through technological progress Improve the quality level of Chinese patent medicine, and actively promote the safety re evaluation of traditional Chinese medicine injection Point 3 will the reform shorten the time for multinational pharmaceutical companies to enter China with innovative drugs? Is there a goal to solve this problem? The reasons for the lag of foreign drug market in China: 1 New drugs are often first listed in the United States, the European Union, Japan, Canada, South Korea, Australia, and then imported to China, which is the current situation in the short term 2 New drugs entering a country need to go through clinical trials and approvals, so it will lag behind 3 It is related to backlog review 4 New drugs must complete phase II or phase III clinical trials abroad to apply for clinical trials in China, which slows down the reform measures by half Support international multi center clinical trials Foreign drugs and domestic drugs conduct trials at the same time The test data can be used for approval in China according to Article 12 of "Reform Opinions": improve the approval of drug clinical trials Allow overseas unlisted new drugs to carry out clinical trials in China at the same time after approval Domestic clinical trial institutions are encouraged to participate in international multicenter clinical trials, and the test data meeting the requirements can be used in the registration application For the application of clinical trials of innovative drugs, it is important to review the clinical value and subject protection Strengthen the responsibility of the applicant, clinical trial organization and ethics committee to protect the subjects Point 4 what kind of impact will the trial implementation of the listing license system have on the future pharmaceutical industry? The drug holder system is a common drug management system in the world Previously, the drug approval number must be approved to enterprises with production qualification Now, the scope of the holder of the approval number is extended to scientific research personnel and research and development units, and the system of separation of the holder and the production enterprise is implemented There are two advantages: 1 Encourage scientific researchers to innovate and develop new drugs; 2 Reduce repeated construction It is not necessary for every subject with approval number to build a production enterprise Article 9 of the "Reform Opinions": carry out the pilot of drug listing license holder system Drug R & D institutions and scientific researchers are allowed to apply for registration of new drugs When transferring to enterprises for production, only on-site process inspection and product inspection of the manufacturing enterprises are carried out, and the technical evaluation of drugs is no longer repeated The pilot work shall be carried out after being authorized in accordance with legal procedures Point 5 what is the incentive system for the review and approval of innovative drugs? What is the special review and approval system? 1 Speed up the review: as long as the products that meet the characteristics of innovative drugs and have clinical use value, they will be queued up separately and organized to review by specially assigned persons, so as to shorten the queuing time 2 Encourage the innovation of scientific researchers and scientific research institutions with the system of marketing license holders 3 During the review, innovative drugs can constantly modify and improve the supplementary information, while generic drugs are not allowed 4 Expand the scope of special review, and include in Article 8 of the "Reform Opinions" on drugs that are really urgently needed in clinical practice and cannot be excluded from innovation: accelerate the review and approval of innovative drugs Special review and approval system shall be implemented for innovative drugs We will accelerate the review and approval of innovative drugs for the prevention and treatment of AIDS, malignant tumors, major infectious diseases, rare diseases, and other diseases We will include drugs that are listed in major national science and technology projects and national key research and development plans, innovative drugs that are transferred to domestic production and for children, and innovative drugs that use advanced preparation technologies, innovative treatment methods, and have obvious treatment advantages Accelerate the review and approval of new drugs urgently needed in clinical practice, and enterprises applying for registration of new drugs shall promise that the price of their products on the market in China is not higher than the comparable market price in the country of origin or around China Point 6 how to promote medical device innovation? Last year, the special examination and approval procedures for innovative medical devices were issued, and special examination and approval were given to products with core technology invention patents, working principles or functional mechanisms of products that are first in China and have fundamental improvements The medical device evaluation center has set up a special innovative medical device evaluation office As of the end of last month, CFDA has reviewed 186 applications for innovative medical devices, determined that 33 products such as related products meet the scope of innovation, and 10 products have entered the review process At present, seven products such as acellular cornea have been approved as innovative medical products Article 15 of "Reform Opinions" reform the examination and approval method of medical devices Encourage the R & D and innovation of medical devices, list the innovative medical device registration applications with product core technology invention patents and significant clinical value into the scope of special review and approval, and give priority to them Timely revise the standards of medical devices, improve the rate of international standards for medical devices, and improve the quality of domestic medical devices By adjusting the product classification, some mature, safe and controllable medical device registration and approval responsibilities will be transferred from the food and drug administration to the provincial food and drug administration.