Pharmaceutical Network December 2 News Wu Haidong, deputy director of the Consumer Products Department of the Ministry of Industry and Information Technology, said recently，Formulation of "Planning of the Pharmaceutical Industry & LDQUO; Thirteenth Five -Year Plan"，To do a good job of industrial growth，The point is to enhance the ability of medical innovation。& ldquo; 135 & rdquo;，The key is to implement the innovation -driven development strategy，Place innovation at the core position of the development of the pharmaceutical industry，Constantly improving the company as the main body，market -oriented，Innovation system combined with political, industry, research and research。Industry insiders think，Many policies and supporting rules have been introduced at the national level to encourage drug innovation，Innovative pharmaceutical companies ushered in the golden development period。

 

 

The core of industrial development is innovation

 

 

On the 28th China Pharmaceutical Industry Development Summit Forum held on November 30，Introduction of Wu Haidong，& ldquo; 135 & rdquo; Plan is preparing for preparation，From the Ministry of Industry and Information Technology、Development and Reform Commission、Health and Family Planning Commission、Business Department、Five departments of the Food and Drug Administration compiled，Entrust the China Medical Enterprise Management Association to carry out preliminary research。

 

 

Innovation for the pharmaceutical industry，Wu Haidong said，Enterprises above designated size & ldquo; 135 & rdquo;，R & D investment in leading enterprises strives to reach 15%。At the same time，To make full use of the Internet、Big data and other means to improve innovation ability，Organize different innovation subjects stake sports betting appstake online sports bettingto jointly carry out collaborative innovation，Optimized allocation of innovative resources，Avoid repeated research and development，Improve the efficiency of the use of funds。

 

 

On the specific variety，Traditional advantage varieties for chemicals and drugs，Wu Haidong pointed out，Realizing the upgrading and development of raw materials is & ldquo; 13th Five -Year Plan & rdquo;。Specifically includes，Develop raw medicine in suitable areas，Study the policy environment and industrial foundation required for these areas。Around & ldquo; Belt and Road & rdquo; development strategy，Encourage the material pharmaceutical company to go global，International cooperation in the production capacity of raw materials。Encourage superior enterprises to carry out large -scale mergers and reorganizations，eliminating backward production capacity。Encourage enterprises to target international peers for technical transformation，Optimized craft route，Advanced equipment，Improve the level of production information，Ensure product quality through digital management。Efforts to achieve low energy、Low pollution，Realize green development。

 

 

About preparation，Wu Haidong proposed，At present, the level of preparation and exports in my country is not commensurate with the status and industrial scale of a large pharmaceutical country，Accelerate the upgrade of the pharmaceutical industry，Transition from upstream to downstream，Being best for a compulsory agent is the way to do。5 years in the future，The pharmaceutical industry should drive the transformation and upgrade with expanding the export of preparations、Effective use of production capacity and expansion of the industry scale，Give full play to the complete advantage of the industrial chain that has been formed in my country，Especially the cost advantage of the raw medicine，Invest in the international layout，Continuously improving the preparation certification capabilities and international cooperation capabilities of developing countries to regulate markets，Yang Long avoid weaknesses，Find differentiated competition，Form its own characteristics，Pioneering international high -end market。

 

 

At the same time，Comprehensive implementation of the consistency evaluation requirements of the quality of generic drugs，Improve the quality level of chemical generic drugs，Complete the quality consistency evaluation task of oral oral preparation in the country;，Establishing a early warning mechanism for drug shortage、Dynamic production and supply，Establish 3-5 small varieties centralized production Stake Sports Bettingbases nationwide，Realize stake betting appthe large -scale production of small varieties，to generate scale benefits，Mobilize the enthusiasm of the enterprise。Expand the basic drug pilot，Add pilot varieties，Improve the central and local levels of reserves，It is necessary to meet the needs of the disaster and epidemic，It is necessary。

 

 

A number of supporting policies for help

 

 

Since August this year，Multiple policies at the national level，Dingli support innovative drug development

 

 

"Opinions on Reforming the Approval System of Reform Drugs Medical Devices" promulgated on August 18，It is intended to improve the quality of generic drugs，Encourage the development of innovative drugs。Industry insiders think，Super superimposed "Regulations on the Implementation of the New Drug Administration Measures" and the new version of the "Administrative Measures for Drug Registration"，The purpose is to reform from the system that hurts the bone -shaped bone -type。& ldquo; The state's importance to the development of new drugs has risen to a strategic level，Chinese pharmaceutical innovation will usher in a new stage of development。& rdquo; Zhang Hua, the person in charge of the research and development of a pharmaceutical company in Shanghai。

 

 At the end of October，"Decision to authorize the State Council to carry out the pilot work of drug listing permit holders and the pilot project of drug registration and classification (draft)，Organize the pilot of the holder system of the drug listing permit，Allow drug R & D institutions and researchers to obtain the drug approval number，Pilot pilot reform of drug registration and classification in the field of chemical drugs。

 

 

The so -called drug listing license holder system refers to the holder of the drug approval number，Including pharmaceutical manufacturers、R & D institutions and researchers，Push the medicine to the market in your own name，and the system that assumes the corresponding responsibility for the entire life cycle of the medicine，It is a drug management system commonly implemented in the international community today。

 

 

This has formed a major benefits for domestic new drug developers。Domestic drug developers in the past cannot apply for registered medicines，can only transfer the research and development results to the drug production enterprise，or set up a drug manufacturer by yourself for production，Is not conducive to mobilizing the enthusiasm of developers，It is not conducive to encouraging drug innovation; at the same time, the existing pharmaceutical company production capacity cannot make full use of，Low -level repeated construction is serious。

 

 

November 4，Pilot holder system pilot pilot of the drug listing license is officially opened，It My stake betting appstake online sports bettingwill be in Beijing in the next 3 years、Tianjin、Hebei、Shanghai、Jiangsu、Zhejiang、Fujian、Shandong、Guangdong、Ten provinces (municipalities directly under the Central Government) of Sichuan launches pilot work。

 

 

Innovative Pharmaceutical Companies are well -caredable

 

 

Zhang Lianshan, deputy general manager developed by Hengrui Pharmaceutical, said: & ldquo; National level made major reforms in the approval of drug review，It is a major change for my country's pharmaceutical innovation environment，It has great support for innovation，The enthusiasm for promoting the development and innovation of domestic pharmaceutical companies，The improvement of the quality of new drugs and the speed of listing are of great significance。& rdquo;

 

 

In recent years，The country has been promoting drug innovation development at all levels，Especially for the innovative research and development of major diseases and clinical urgent drugs。2009 "Regulations on the Management of Special Approval of New Drug Registration" promulgated and implemented，2013 "Definition of Biological Products Special Approval Procedure Definition"，At the same time, "The Working Procedures for Clinical Urgent Improved Drug Priority Review" is also formulated。

 

 

series of policies launched one after another，It has brought an effective promotion role to the listing of product declarations。As of March 11, 2015，CDE's major special registered product acceptance number has a total of 205，​​Registered product acceptance number of special channels has 942，Including the import acceptance number 391 and 551 domestic product acceptance number，Anti -tumor drugs are the areas with the most special channels for application。Where，The total number of special approval varieties of Hengrui Pharmaceutical、The largest number of clinical declarations and production declarations。A new type of new medicine IReemibu, which has been listed in Hengrui、Apatinib and other heavy products such as oxulfinic acid are listed through special approval。In addition，Jiangsu Haosen、Zhejiang Haizheng, etc. It is also a company with special review and approval products。

 

 

& ldquo; What needs to be noted is，The documents at the level of the State Council are mainly framework content，The State Administration of Food and Drug Administration should introduce more operable detailed documents，For example, whether the tumor drug will adopt a filing system; whether the review and approval time can be shortened for 2-3 months; how to define rare diseases，Will the country be supported in terms of price and tax。& rdquo; Zhang Lianshan told China Securities News reporter。

 

 

Zhang Hua said，From the perspective of the development stake online sports bettingof stake betting apprare diseases in the United States，The follow -up support policy has a vital effect on the speed of drug listing。Especially the 2012 FDA Security and Innovation Act was officially implemented，Cancer drugs、R & D and listing of anti -infective drugs is greatly accelerated。Hongyuan Securities Research Report Research，The drug approved by the FDA in recent years has increased significantly。

 

 

This means，Establishing specific implementation rules may become a key factor in the development speed of a certain field，Different solutions are given to different situations to be more operable。Zhang Hua pointed out，At present, many problems in research and development in many domestic medical areas are not the same，For example, the research and development obstacles of children's drugs are not in the fast and slowness of review and approval，and in difficulties in research and development，Including clinical trials and drug pricing。​​& ldquo; China's local R & D and innovation capabilities have made great breakthroughs in many fields，In the future, the state's encouragement and support of drug innovation cannot be at the level of directly project funding support，Develop relevant policies，Let companies see more long -term development paths and prospects，The environment is more transparent，Policy planning is clearer，is the most needed for R & D enterprises。& rdquo;