Medical network May 16 - May 11, state food and drug supervision and administration bureau issued "about to encourage pharmaceutical medical equipment innovation to speed up the new medical devices to appear on the market for examination and approval of the review of relevant policy" (no. 52, 2017), the reform about medical equipment innovation encourage drugs clinical trial management policies "(no. 53, 2017)," about to encourage pharmaceutical medical equipment innovation drugs in whole life cycle of medical equipment management policy "(54 2017) three draft and comment deadline is June 10. 

 

The reporter understands that the current discussion in the industry is mainly focused on article 53. Article 53 # 5 points out, "to carry out before drug clinical trial stage Ⅰ and Ⅲ communication must be approved by the applicant and the review meeting after formal applications and accepted. Need for examination and approval of medical apparatus and instruments, before clinical trials must be approved by the applicant and the review meeting after the communication application and acceptance. The review agency 60 working days from the date of acceptance, did not give a negative or be deemed to have agreed to review opinions, the applicant can be submitted in accordance with the plan to carry out clinical trials." 

 

Six pieces of good news 

 

An unnamed industry authoritative expert analysis, said # 52, # 53, 54, has led to a lot of good information, including six good news if you can formally be born, will further improve China's drug innovation environment at present. Article 52 of article 52 indicates that the development of drugs and medical devices for rare diseases is supported. The catalogue of rare diseases, published by the health and family planning department, establishes the registration system for the registration of rare diseases. The applicant for the treatment of rare diseases and medical devices may offer a waiver of clinical trial application and speed up the examination and approval of medical devices for medical devices for rare diseases. For the rare medical treatment and medical devices that have been approved for the listing abroad, the listed company may be approved for the listing, and the relevant research will be made up after the ipo. 

 

Article 6 of article 52 points out that encouraging medical institutions to prioritize and use drugs that are clear and reasonably priced. Perfect directory of medical insurance drugs research dynamic adjustment mechanism and explore to establish a system for payment of medical insurance drugs standard negotiations, support innovation medicine in accordance with the provisions incorporated in the basic medical insurance to pay limits. All localities may, according to the prevention and control of disease, organize and purchase centralized purchasing units in provinces (autonomous regions and municipalities directly under the central government). 

 

The industry's long-awaited "accreditation" of clinical trials has changed to "filing management". Article 1 of article 53 points out that the qualification of the clinical trial organization is revoked. Medical institutions with clinical trials and conditions may accept the application for clinical trials after the food and drug administration has designated the website for registration. We will encourage social capital investment to establish clinical trial institutions and provide professional services for clinical trials. The main clinical trial researchers should have senior titles and have participated in more than 3 clinical trials. The clinical trial applicant may hire a third party to evaluate the qualifications of the clinical trial organization. 

 

The answer is given in article 6 of article 53 for the intercommunication of clinical data within and outside the country. Outside the applicant in the clinical trial data, in conformity with the requirements of the relevant Chinese medicine medical device registration after on-site inspection can be used for filing an application for registration in China. Foreign enterprises in China international multicenter clinical drug trial, complying with the requirements of drug registration related, after completing the international multicenter clinical trial can directly apply for listing. In China for the first time, applicants should provide clinical trial data that do not have racial differences. Applicant drug administration in Europe, the United States and Japan approed generic bioequivalence test data, to meet the requirements of drug registration in China, after the on-site inspection can be used to declare generic drug registration in China. Applicant approed for sale in foreign medical apparatus and instruments, in addition to the need for clinical trials to the approval of the third class medical apparatus and instruments, outside submitted when an approed for clinical trial data, can be used as a clinical trial data are used to declare medical device registration in China. 

 

Industry a number of experts believe that, no. 54 release the biggest positive, there are two: one is article 1, to summarize the drug marketing authorisation holder pilot experience, combined with the revision of the pharmaceutical administration law of the People's Republic of China, the marketing authorisation holder system in the national drug and medical device license (registration) of common practice; Secondly, the article 7, drug review of medical equipment should be brought into the scope of government purchase service, provide the applicant with specification and efficient review of services, and establish the listed pharmaceutical medical equipment archives. 

 

Multiple questions remain 

 

Held on May 12, "the Chinese medicine industry future leaders summit", have participants also pointed out that this comment file and some measures to accelerate the new drug research and development into clinical trials can be added. For example, should the clinical trial application for original new drugs be applied to the principle of "risk-based regulation", eliminating all aspects of the provincial bureau's on-site inspections? Or clear clinical trial application (IND) products and new drug applications (NDA) and put forward a clear timetable, the requirement of the on-site inspection to avoid extra time sometimes for several months. 

 

In addition, many industry experts have raised questions about the new practice of "meeting the review board." They believe that it is difficult to determine the time limit for the meeting of appraisal organizations based on the technical level and number of personnel in China. For examination and approval of the original innovative drug review mainly "card" on the review of the problem of slow speed of examination and approval, how to ensure that the review agency meeting the time limit of issues that need to be further clear, otherwise it is difficult to fundamentally solve the problem of innovative medicine slow for examination and approval of the review. 

 

Gilead sciences director of the central government market access Yu Kun given by the "2010-2016 global innovation medicine", according to the current innovative drug r&d present three features: cycle longer and longer, more and more big, the risk is higher and higher. In 2016, three-fourths of the world's new chemical structures were first approved by the us FDA, while countries such as the European Union and Japan were quick to catch up, but China is still at zero. 

 

"Three draft do release to Chinese new drug has injected new vitality for examination and approval of the review, but the health care and so on many policy needs to keep up with the pace of reform, so as to attract more multinational companies bring new products to declare registered in China." Yu Kun argues that China should according to the severity of disease away different categories drug reimbursement ratio: the more serious the disease, the higher reimbursement ratio, such as cancer, HIV/AIDS drug reimbursement 100%. At the same time, according to the drug ASMR, ASMR ratings are better and the reimbursement rate is higher. 

 

In addition, for the pricing of new drugs, Mr Yu suggests that China can learn from its experience in Japan and Taiwan. One is similar to the pharmacodynamic comparison. The new listed drugs are compared with those that have been listed on the market, and they are priced in combination with drug innovation. The second is cost pricing. If the listed drugs are not comparable to the existing ones, the cost of production shall be combined with reasonable profits and expenses. The third is the price comparison. Based on the above method, the price of new drug is adjusted according to the international average price and price ratio. 

 

Sound > > > 

 

Dr. Yang junjun, chairman and CEO of yaxin medicine, 

 

"Three of the documents, which encourage drug development to be more aggressive than we think, are clearly in line with international engagement. 

 

The company is also concerned with the policy of encouraging the innovation of pharmaceutical medical devices innovation in clinical trial management (draft). The first of its documents is to change the qualification of clinical trial institutions to the management of the filing. This is the basis for the development of drug companies' innovative drugs, which cannot be done without the support of clinical institutions. Now, it has been changed to the record, and the qualifications of the researchers have been made, and the medical supervision department is required to conduct on-site inspections and public disclosure, and ensure that transparency and openness are guaranteed in a certain mechanism. 

 

But it is important to note the responsibility of the bidders. Whether or not a clinical trial institution has the conditions, an enterprise can assess itself by hiring a third party, or if it has a condition for its own enterprise. There will be concerns about whether clinical trials will be in place for the record, and there will be a lack of oversight, so it is important to clarify the role of the bidders. 

 

Of course, in our view, the most important thing is the "optimizing the clinical trial review process". Its rules, the review mechanism of handling within 60 working days, did not give a negative or be deemed to have agreed to review opinion question, the applicant can be submitted in accordance with the plan to carry out clinical trials. This approach, which is in line with international rules, is conducive to an orderly development of corporate r&d, rather than a missed opportunity for too long. 

 

And we are also looking forward to the arrival of formal documents in the acceptance of data from overseas clinical trials. As an innovative pharmaceutical company that is very close to international cooperation, it is an international practice to accept data on clinical trials that do not exist outside the racial divide. Ensures the rights and interests of patients, on the other hand, also is advantageous to the enterprise to carry out the international strategic cooperation, improve the efficiency of research and development and the product, improve the competition advantage in the international competition. " 

 

The head of the pharmaceutical industry said: 

 

"Last night, country netting three draft about encouraging drug innovation, our company is very attention, obviously feel the administration to speed up the urgent clinical needs by medical device review of reform of examination and approval of new drugs of determination and effective measures, to all the companies doing drugs is a major positive. Of course, some reform process involving the department in charge of more than the CFDA, may need higher level of form a complete set of coordination. 

 

"About to encourage pharmaceutical medical equipment innovation to speed up the new medical devices to appear on the market for examination and approval of the review of relevant policy" the document mentioned, as to speed up the clinical need of products, to encourage measures is very big, will guide enterprises to adjust development strategy and direction, to pay more attention to the clinical requirements development product, not just to be a new compound. 

 

Ding medicine is given priority to with independent research and development and cooperative development again, these reform measures, will make us more directly in the face of international competition and cooperation, both opportunities and challenges. We will pay more attention to the clinical needs, in view of domestic clinical need to develop new drugs, such as platinum sensitive maintenance treatment of recurrent ovarian cancer, there is no effective treatment at home now. "