Medical network - February 22 June 2016, as the general office of the state council issued by the drug marketing authorisation holder system pilot scheme, licensor officially listed in China Beijing, tianjin, hebei, Shanghai, jiangsu, zhejiang, fujian, shandong, guangdong, sichuan and other 10 provinces (municipalities) to carry out the pilot work.
In addition to the hebei province, the basic all the food and drug administration of pilot provinces and cities have issued their own implementation plan.
Under control from the perspective of information, policy information, at present the country CFDA has opened under special column "pilot" drug marketing authorisation holder system, special food and drug administration in provinces and cities set up "pilot" drug marketing authorisation holder system special columns province only Shanghai, Shanghai is the only published a filed for varieties of drug marketing authorisation holder system reform pilot list of pilot provinces and cities.
In January 2017, the CFDA issued as of the date, December 25, 2016 the pilot province pharmaceutical marketing authorisation holder pilot varieties reporting statistics.
According to the overall acceptance, data statistics, guangdong first, jiangsu second, followed by Shanghai and shandong. Clinical trials for accounted for 59% of the overall application. From clinical trial application to calculate, guangdong, jiangsu and shandong in the top three; If the listing application statistics, Shanghai, jiangsu and zhejiang tied for first; Supplementary application aspect, Shanghai ranked the first, second shandong, fujian. 3.
Although the CFDA released drug marketing authorisation holder pilot varieties to declare, but the pilot variety information and corresponding enterprise at present the CFDA has not publicly available information.
Shanghai is the only one who has applied for drug released authorisation holder system reform pilot varieties list of pilot provinces and cities.
Guangdong, jiangsu has reported progress summary, but no detailed data. Shandong, fujian, zhejiang, sichuan, Beijing, tianjin and hebei have varieties of detailed data, also no progress summary report.
Guangdong: temporarily only class 1 new drug declare pilot varieties
From guangdong food and drug administration issued the "guangdong made solid progress" drug marketing authorisation holder system pilot work information, the acceptance of class 1 new drug, in the southern province of guangdong have 47 accept order filed a petition for pharmaceutical marketing authorisation holder at the same time, the bureau of guangdong province has been completed report acceptance and on-site inspections of the varieties of national administration.
Currently published by guangdong drugs declare only one kind of new and old registered segment reporting chemicals 2, 4, 5 (only targeted agents, sustained-release preparations, controlled-release), traditional Chinese medicine and natural medicine 2-6 classes, treatment with biological products category 7 similar to biological medicine; After implementation and chemical drug registration classification reform, according to the new classification of chemical drug registration (hereinafter referred to as the new registered classification) declare chemical declaration of class 2 blank for the time being.
The annexation and reorganization of large pharmaceutical group in guangdong province, the overall relocation and other pilot work has entered the stage of the implementation of the operation level, thus no supplementary application data. In addition, according to the in line with the original drug quality and curative effect of the new standard approved generic listing of licensor declare also is still a blank.
Shanghai: only released details of the 12
On October 25, 2016, the Shanghai municipal food and drug administration of Shanghai has been applied to varieties of drug marketing authorisation holder system reform pilot list announcement (October 25, 2016), published in the 12 varieties, because 1 varieties contain API 1 accept order, dosage form, another to accept order corresponding to accept the number of the 12 close to 25. Applications from 50%, according to results released from class 1 new drug, 50% comes from chemical medicine of generic drugs, no Chinese medicine application.
Shandong province: the first drug marketing authorisation holder system pilot varieties fall to the ground
In September 2016, shandong listed licensor to accelerate the pilot work, to attract more new varieties, new technology in shandong province, shandong province bureau of construction of "supply and demand information platform" pilot project, promoting holder exchanges and cooperation with production enterprises, and published the pharmaceutical production enterprise in shandong province to undertake marketing authorisation holder entrust production intent ability summary table. 105 in shandong province pharmaceutical production enterprise is willing to accept commissioned production, dosage form covers the oral and external use, injection, pharmaceuticals, biological products, such as major categories.
On December 23, the treatment in shandong qilu pharmaceutical research and development of new drugs approved by the CFDA holder for document, become the first drug marketing authorisation holder system pilot varieties.
Sichuan: determine 5 drug marketing authorisation holder system testing
Pilot provinces and cities in sichuan province are all be born policy incentives products in the most positive provinces. Released in June 2016, in sichuan province, the key link of the top ten pharmaceutical r&d implementation scheme, key support to enterprises as the leading factor of the pharmaceutical industry led by technology innovation system and support by the enterprise production, medical cooperative innovation platform, bio-pharmaceutical and new emerging industries such as high-end chemical pharmaceutical, traditional Chinese medicine of rare and endangered species in sichuan and authentic medicinal materials for protection, breeding system and industrialization development areas of the five key links.
In August 2016, in sichuan province food and drug administration has asked the chengdu high-tech zone, chengdu salween, luzhou medical industrial park, meishan economic development zone, YueChi pharmaceutical industrial park, a total of five drug marketing authorisation holder system gave nameboards pilot demonstration area of sichuan province.
On January 11, 2017 in sichuan province on the drug marketing authorisation holder system pilot work of the implementation opinions ", for the province's top ten in the holder of the applicant, the provincial finance one-time give appropriate reward; Municipalities (state) according to the actual situation of the people's government incentives. But it is not clear this is the top 10 refers to get production approval or for testing can be rewarded.
Although now sichuan don't declare the number of top in ten pilot provinces, is expected to weigh award under the will power, declaration of the marketing authorisation holder in sichuan province will be dramatically increased.
Beijing: marketing authorisation holder variety registration priority review
In November 2016, the Beijing municipal food and drug administration about print and distribute "Beijing drug registration measures for the priority review mentioned in the announcement, to apply for the marketing authorisation holder medicines at the applicant may apply to the municipal food and drug supervision bureau for priority, complete Ⅱ stage of clinical trials and in Beijing applying for marketing authorization and is for the marketing authorisation holder medicines may apply to the municipal food and drug supervision bureau for management of project scheme, into the preferred procedure.
Other varieties of no detailed data did not progress summary of the province
Jiangsu no detailed data. In December 2016, xinhua "promote the reform of drug approval for examination and approval in jiangsu, jiangsu has 17 units in accordance with the requirements of the pilot to submit registration item 19 varieties of 34. And in November, the provincial drug marketing authorisation holder system pilot work conference held in ning ", the data of four units of 4 varieties submitted for eight registration according to the requirements of the pilot.
Will take the lead in biological medicine in xiamen port, fujian province, fuzhou, sanming pharmaceutical industry clusters and ZheRong hercynian YaoCheng holder pilot work to explore
Conclusion:
For marketing authorization holder pilot varieties to declare is not transparent, the provincial information is very fragmented. Has now been released to declare is given priority to with clinical trial application, listing of the declaration is very limited. From the incentive view, sichuan incentives are in place. In terms of information release, Shanghai relatively open and complete data. |
