Review of examination and approval reform for innovation medicine "decoupling"

The 2017-04-03

Source: booz net economic daily

Takeaway: backlog of drug approval Numbers are down from nearly 22000 to 8200 to encourage innovation is our country from a big pharmaceutical drug development toward the path of medical power, but the current time is too long for examination and approval of drugs in the innovation of speed. Therefore, on the one hand, to reform the drug clinical trial management mode, accelerate the new drug clinical trials for examination and approval; On the other hand, to speed up the urgent clinical needs drug approval listed and drugs for more innovation

Drug approval number of backlog declined from nearly 22000 to 8200

Encourage drug development innovation is our country from medical powers to the path of medical power, but the current time is too long for examination and approval of serious restrict the speed of drug innovation. Therefore, on the one hand, to reform the drug clinical trial management mode, accelerate the new drug clinical trials for examination and approval; On the other hand, to speed up the urgent clinical needs of pharmaceuticals listed for examination and approval, as more innovative drugs listed "decoupling" --

In the recently held a national work conference on drug registration management, national food drug safety administration deputy director wu said: "since the opinion about drug review of medical equipment examination and approval system reform, implemented for more than a year, China's pharmaceutical industry obviously improved policy environment, the pharmaceutical industry a good momentum of development, increasing science and technology enterprises, pharmaceutical innovation blustery, innovative drugs for examination and approval of the review is accelerated, liuzhou eliminating effect are emerging".

Specific terms, the drug registration review efficiency improved significantly. By the end of 2016, after waiting for review for drug registration number by the backlog of 2015 at the height of 22000 to nearly 8200, registration, effectively relieve backlog status. In the last year to accept 4504 for drug registration, varieties reporting structure also optimized. Chemicals, for example, is for chemical innovation drugs in 2016, 240, a 18% increase over 2015, to complete the new drug clinical trials and new drug applications a 37% growth in 2015 and 37% respectively.

At the same time, the urgent clinical needs big shortening time limit for examination and approval of drug approval, public accessibility improved significantly. Of antitumor drug GeFei, slice, and malic acid nai anti-infection drugs that peptide lu capsule, the endocrine system drugs injection, respiratory system diseases and allergy drugs golden flower clear sense of particles, prevention for pneumococcal conjugate vaccine and other biological products 13 price of a batch of deal with a serious public health problem and major refractory disease first imitation innovation medicine and medicine through priority review examination and approval to enter the market, solve the problem of some patients without cure, significantly improved the public get feeling for the drug approval for examination and approval system reform.

It is important to note that in the new drug registration classification after implementation, domestic drug innovation enthusiasm increased significantly, a batch of research and development of the international forefront of innovative drugs have to accept the declaration. As of January 31, has been classified according to the new chemicals application for registration of 330 pieces, including innovation medicine 184, accounting for 55.76%.

"Innovation is the eternal theme in the pharmaceutical industry development, from medical powers to the path of medical power, encourage drug development innovation is also a clear direction for examination and approval of the drug approval system reform." Wu said that the current drug innovation is the most prominent problem is the drug clinical trial approval time is too long, had a great influence on innovative drug seize market opportunities.

Clinical trials can change? Wu thinks, on the one hand, to reform the 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.

On the other hand, to speed up the urgent clinical needs drug approval listed and conditionally approved for urgent clinical needs of 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.

Also, improve technical support ability and level for examination and approval of the review, set up food and drug supervision and administration bureau unified command scheduling, based on risk and review need check mode, build the atmosphere to encourage innovation, study and formulate pharmaceutical test data protection system, effectively protecting the legal rights and interests of drug patent holder.

"2017 is deepening the reform of drug approval system of examination and approval of crucial years, drug registration task of an unprecedented." National food administration of drug safety, director-general of the department of medicine, registered Wang Lifeng revealed that in view of the current lack of r&d investment in the industry as a whole, lack of r&d personnel, clinical research ability is weak, drug research and development innovation policy the status quo of the ecological environment is not sound, this year will further encourage enterprises to study and formulate innovation policy measures, including reform of drug clinical trial management mode, explore the mode of conditional approval, encourage the current lack of effective treatment of major refractory disease, a rare disease for drug registration. Registration will be carried out at the same time, also the pharmaceutical production process, establishing database of production technology, establish archives for drug varieties to establish drug directory set, guide generics consistency evaluation work carried out smoothly.

"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." Wu said that this year will continue to improve the drug quality as the core, strictly the quality of the new approval of generic drugs, mind increment, completes the quality and consistency curative effect evaluation of drugs already on the market, improve the quality of the stock and accelerate the generics consistency evaluation work.