Medical network - March 27 March 23 ~ 24, the national drug registration management work conference held in Beijing. 

 

Reporter has learned that at the meeting, in 2016, the drug approval for examination and approval system reform deepening, the urgent clinical needs by a group of innovative medicine and drug approval by priority review into the market, the public accessibility improved significantly. Wu zhen, deputy chief of the state food and drug supervision and administration bureau to attend the meeting and delivered a speech. 

 

It is understood that in 2016 the drug registration review efficiency improved obviously, the backlog of drug approval number from September 2015 at the height of nearly 22000 of them fell to 8200, basically eliminated the backlog of registration. Drug registration filing varieties structure optimization, chemicals, for example, dealt with 240 chemical innovation drugs application in 2016, a 18% increase over 2015, completed clinical trials of new drugs and new drug applications a 37% growth in 2015 and 37% respectively; Compared with 2015, the generic application decreased by 92%. 

 

For urgent clinical needs by speeding up drug approval, the public medical accessibility obvious ascension, of which 13 price pneumococcal conjugate vaccine, bei that lu peptide injection, fumaric acid tenofovir two pyrazole cefuroxime ester, baida fumaric acid quinoline, malic acid, the effect of the treatment, slice, golden flowers are particles a batch of deal with a serious public health problem and major innovation of incurable disease for urgent clinical needs by drugs and medicine by priority review approval to enter the market. 

 

For human medicinal social widespread concern in the reform of several key work, the meeting also has carried on the deployment. 

 

01, accelerate the generics consistency evaluation BE further enrich experiment resources 

 

In 2016, the administration of consistency evaluation office received more than 4000 applications reference preparations, the record of more than 700 varieties. In succession recently released the generic reference preparation directory two batches of more than 80 varieties. 

 

This year will continue to improve the drug quality as the core, accelerate the generics consistency evaluation work. To speed up the pace of reference preparation of, encourage enterprises to choose. Enterprises submitted to administration for the record of the reference preparation all publicly to the society, independent decision and responsibility by the enterprise. 

 

Administration of resources in order to further enrich BE experiment, recently, by organizing the clinical test units BE test on training, promotion agency BE test of ability and motivation; Acceleration has completed more than 100 new drug clinical trial institution of on-site inspection, stay in May after the qualification, the country has to BE pilot qualifications will reach more than 600, is beneficial to alleviate the current generic consistency evaluation BE test requirements, and the contradiction between the high level of resources. 

 

At the same time, further promote drug clinical trial institution qualification changed from examination and approval administration for archival filing management. 

 

02, expand coverage for authorisation holder pilot allowing pilot varieties more production 

 

Drug marketing authorisation holder system pilot since November 4, 2015, obtain the authorization of the National People's Congress, has so far received 268 applications. 

 

Administration of this year will accelerate the drug marketing authorisation holder system pilot, we will further expand coverage for pilot work, clear the overall relocation requirements, refining agent production enterprise qualification requirements, allowing pilot varieties more production. Strengthen pilot varieties of registered personal communication, on the part of the pilot varieties for examination and approval of application for registration shall be priority review, simplify the approval procedures for the review of pilot production varieties entrusted enterprise change. 

 

Actively explore the different types of pilot pattern, encourage pharmaceutical research institutions, scientific research personnel, pharmaceutical production enterprises to participate in the pilot, encourage all parties to explore drug quality and safety responsibility mode, encourage guarantee agencies, insurance institutions to participate in the pilot work. Timely drafting and improve the system of pharmaceutical marketing authorisation holder file system, forming can copy can promote the normative documents, summary report of pilot work overall situation in a timely manner. 

 

03, to further encourage innovation Improve the accessibility for treating patients 

 

Encourage drug research and development innovation, is a clear direction for examination and approval of the drug approval system reform. 

 

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 yet perfect, administration of this year will further encourage enterprises to study and formulate innovation policy measures, including reform of the drug clinical trial management mode, explore the mode of conditional approval, encourage the current lack of effective treatment of major refractory disease, rare disease drug registration; Draw lessons from international experience, in the drug approval review intensify protection of pharmaceutical intellectual property; To carry out the drug registration production technology, establishing database of production technology, establish drug varieties files; Build system of China Orange Book, guide generics consistency evaluation work smoothly; Research to explore the market of rare diseases and orphan drug use of antibiotics exclusive rights protection system; Together with the relevant departments to establish the original drugs and high quality generic drugs into the system and mechanism of health insurance directory and prior purchasing as soon as possible.