Medical network - on March 24
Encourage drug discovery to optimize clinical trials for examination and approval of the review
On March 23, "the national drug registration management work conference" was held in Beijing. Medicine economic newspaper reporter has learned that at the meeting, after the introduction of new registered classification, domestic drug innovation enthusiasm high, a batch of research and development of the international forefront of innovative drugs have to accept the declaration, as of January 31, 2017 have been classified according to the new dealt with 330 chemicals application for registration, the innovation medicine 184, accounted for 55.76%.
Wu zhen, deputy chief of the state food and drug supervision and administration bureau, said the rapid development in recent years, China's pharmaceutical industry, increasing science and technology enterprises, pharmaceutical innovation blustery, innovation policy incentives for medicine, for the enterprise to create a good environment for development, is the duty of drug regulatory department."
One is the implementation of chemical medicine registration classification reform. To improve the standards for examination and approval of the review, solve the newly approved drug quality, safe and effective, in 2016 the state council has approved the 3 menstruation, the administration released the chemical classification reform for drug registration scheme, adjust new definition for "not publicly listed company in China selling drugs", will review approval to focus on innovation and improved the clinical value of new drugs and application advantages, so as to promote the quality of medicines and improved.
Second, the drug marketing authorisation holder system pilot. To encourage innovation, authorized by the report to the National People's Congress, and other 10 provinces (municipalities) in Beijing to start the pilot, drug marketing authorisation holder system allows drug marketing authorization and the production license of phase separation, allowing scientific research units and technological workers to apply for new drug registration, purpose is to strengthen the responsibility main body status, the applicant and holder quality comes from the design of whole life cycle of drug quality control idea, encourage new initiative enthusiasm, optimize the allocation of resources, to carry out the principal responsibility, promote industrial upgrading. "Also hear some voice from the industry, the marketing authorisation holder system makes scientific research institution and scientific research personnel have more choice, not only selling green crops, the enthusiasm for new drug research and development to improve at the same time, also inspired social sector investment activity, solved the problem of shortage of enterprise r&d. Some biological products enterprise budget, participating in pilot reforms would" unbundling "research and development and production, can save cost of 500 million yuan, is expected to shorten product time to market for 3-4 years." System, actively promote the pilot provinces and cities, the current according to the pilot scheme for declaration registration has amounted to 268 pieces.
Three is to establish priority review system of examination and approval. To encourage innovation, in November 2015, the bureau issued a "about the drug registration review approval announcement of a number of policy, to improve the standard for examination and approval of generic drugs, optimizing the review of clinical trial application with varieties of examination and approval, shall be subject to the centralized review, speed up the urgent clinical needs the approval of drugs such as 10 items to make the corresponding provisions. Administration and issued in February 2016, a priority review opinions of examination and approval, will have significant clinical value of three types of 17 cases of innovative medicine and clinical needs, market shortage of drugs into the priority review approval procedures, and ensure patient needs. By the end of last year, 193 pieces of drug registration application into priority review, including 17 pieces of children's drugs. By encouraging innovation, speed up the review, a number of allowed to enter the "new world", a group of innovative drugs and clinical need drugs approed.
The adjustment of the classification of drug registration and marketing authorisation holder system pilot and priority review of the implementation of examination and approval, the led industry drug innovation and improve the quality of enthusiasm, will greatly promote the "new" drugs in the international market and China market synchronization of research and development, accelerate global cutting-edge technology products applied to clinical research in China and listed.
Overall, after more than a year of reform, drug development obviously improved the ecological environment, innovative drugs for examination and approval of the review is accelerated, liuzhou eliminating effect are emerging, development center under the state council and the London school of economics of joint research pointed out that China to solve drug regulation enacted a series of New Deal, is moving in the right direction. McKinsey, a consultancy, thinks that in the United States, China's pharmaceutical industry obviously improved policy environment, the pharmaceutical industry has a good momentum of development, innovation driven ecosystems have been preliminarily formed.
Wu pointed out that innovation is the eternal theme in the pharmaceutical industry development, from medical powers to the path of medical power. Currently one of the factors that affect drug innovation is a clinical trial, examination and approval of clinical trials for too long, had a great influence on innovation medicine seize market opportunities, become the most outstanding innovation problem. Clinical trials can change? We have some consideration:
One is the reform of drug clinical trial management mode, accelerate the new drug clinical trials for examination and approval. Research on new drug clinical trials for a filing entry, accept foreign drug clinical trial data, gradually realize the domestic and international mutual recognition of clinical data, reduce the development costs of the enterprise. By the drug clinical trial institution qualification examination and approval system is adjusted for records and increase the efficiency of the clinical trial ethical review and strengthen ethical review of clinical trials, to protect the safety and rights of the subjects.
The second is to speed up the urgent clinical needs drug approval listed. Conditional approval for urgent clinical needs by drugs, and there is no effective treatment in treating severe life-threatening disease, are of great significance to the clinical needs of a new drug, solving the applicant according to the research data of have been apply for derate clinical trials; By the early clinical test results show that the initial curative effect, such as to comply with relevant principles and technical requirements, can be listed on the conditional approval; Support for rare diseases registered drug research and development, establish extensibility sympathy for the use of drug clinical trials management system.
Three is to improve technical support ability and level for examination and approval of the review. To adjust the current mode of drug clinical trial project inspection, set up the food and drug supervision bureau unified command scheduling, based on risk, and review need check pattern. Fourth, build the atmosphere to encourage innovation, but also intensify protection of intellectual property and research to develop pharmaceutical test data protection system, effectively protecting the legal rights and interests of drug patent holder.
Advance BE test units from "approval" to "the record"
Reporter learned that, in the meeting at this stage the enterprise to participate in the enthusiasm of the consistency evaluation is very high, 2016 consistency evaluation office received the reference preparation more than 4000 applications, the record of more than 700 varieties. In 2017, the state food and drug supervision and administration bureau will continue to improve the drug quality as the core, accelerate the generics consistency evaluation work, work center of gravity will transition to help and urge enterprises to carry out the evaluation work.
In addition, in order to further release BE test resources, food drug administration recently has completed more than 100 clinical trials of new institutions of on-site inspection, to BE decided in May, after the completion of the country have to BE test ability of medical institutions will reach about 600. Will greatly ease the current generic consistency evaluation BE test the contradiction between demand and resources, at the same time will also discuss the relevant departments to further advance drug clinical trial institution qualification by the examination and approval to the filing management.
Wu pointed out that "generic drugs is the key to solve the medical problems, encourage the use of generic drugs are developed countries around the world including common policies. We need to strict with the quality of the new approval of generic drugs, mind increment, then make quality consistency and curative effect evaluation of drugs already on the market, improve the quality of stock. This is a difficult job, is also a pressing task."
This year, wu asked to do the following aspects:
One is according to the actual progress of work, timely perfect consistency evaluation work path and the allocation of resources, speed up the research to develop critical evaluation of technical guidelines, expand the resources of the clinical trials, coordinate related departments to carry out the relevant incentives, create good conditions for enterprises to carry out the evaluation work.
The second is to solve the problem of reference preparation. Administration of consistency evaluation office will turn 2018 needs to be completed by the end of 289 species of the original enterprise product listing, publish to the society, the reference for enterprises to select the reference preparation. Reference preparation is more complex, some on sale in domestic and some not listed in the domestic, some original have stopped, some can't find who is the original. Even if choose internationally recognized drug for reference preparation have a benchmark problems. Enterprise to the choice of the reference preparation more confusion, hope to have a general reference listing preparations, bureau recently released a batch reference preparations, follow-up will continue.
Three is to solve BE test problems. Businesses generally reflect the medical institution to BE test's enthusiasm is not high, even if there is intend to carry out the test, but the cost is surprisingly high. BE test is consistency evaluation of the gold standard, in addition to the part of the drug in vitro dissolution exemption BE available, the others all need to BE test, in order to solve a test site problems, administration is studying, on the basis of good make full use of existing clinical base, adjust the consistency evaluation of clinical trial base access problem, can start trimming process when necessary, to modify the pharmaceutical administration law of individual terms.
Four is to build our country's listed drugs directory set. Is everyone calls "Orange Book", this system in the past, we didn't, now must be set up, this is an imminent work. Reference to international practice, combined with China's national conditions, to classify new registered after the approval of new drugs and generic drugs and its reference information, through the quality of generic drugs and curative effect evaluation of varieties and its reference preparations consistency information made public, guiding the research and development and filing registration and encourage generics.
Five is to explore the method of injection quality consistency and curative effect evaluation, timely start Chinese medicine injection drug safety, effectiveness and evaluation work.
It is understood that the state council in January 2012 issued by the "twelfth five-year" drug plan is put forward for generic drugs already approved for quality and consistency of curative effect evaluation task, issued by the state council in 2015 "about drug review of medical equipment examination and approval system reform opinions" reiterated that, in February 2016 issued by the general office of the state council concerning the evaluation opinions of generic quality and curative effect of consistency "(countries do hair [2016] no. 8) further clear the finish time limit and related requirements." much starker choices-and graver consequences-in "printed by the state council in February this year again to further improve the quality of drugs, and drug safety planning is approed generic drug medicine quality and curative effect is consistent with the original research. In accordance with the overall deployment of the state council, the administration has carried on the comprehensive deployment to consistency evaluation, was established in November 2015, generic quality consistency and efficacy evaluation office, study and formulate work plans, refine each work procedure, write and a series of technical guidelines, published 10 policy documents and five technical guidelines, set up the consistency of evaluation experts committee, carried out more than 10 field circuit training interpretation of national policy.
"Generic quality and curative effect evaluation, consistency is a significant work reality. Push generics consistency evaluation of the quality improvement of drugs already on the market step by step to solve the problem, this is history lesson." Wu stressed that 2017 consistency evaluation will enter the stage of full implementation. The provincial drug safety system will, as always, attach great importance to this work, to do a personally stresses, appoint someone who's in charge, to form a capable, can fight team, build a linkage mechanism of up and down. Generics consistency evaluation is a pioneering work, task, or more difficult. At present, the enterprise reference preparations for the record number increase rapidly, has formed a "quake lake". Provinces to send high political quality, professional ability of personnel to consistency evaluation office, common to comb and filing a reply, timely and reliably solve the problem. It is support for the work of administration and the provincial training professional and technical backbone of the opportunity. Office also should study how to play to the role of the good send secondments, seriously do a good job in personnel training, make them back consistency evaluation, the seeds of a better place of work, and solve the problems in the actual work with difficulty, to provide efficient quality services and technical guidance for the enterprise. |
