2016-01-08 15:08

 

The State Food and Drug Administration "fake" 36 pharmaceutical companies to withdraw the application for drug registration

 

[straight news network Beijing on January 8 hearing (interface News) according to incomplete statistics, in the about 154 enterprises withdraw 224 drug application for the registration of the notice "in listed drug Qida 36.
January 6th evening, Chinese medicine (600056.SH), Tai Chi Group (600129.SH) have issued a theme with the withdrawal of drug registration application notice. The listed pharmaceutical companies recently appeared in the State Food and Drug Administration (CFDA) published in the official website of withdrawal on the 154 enterprises 224 drug application for the registration of the list.
Previously there are 11 listed companies issued a notice said the company, subsidiaries or affiliated companies appeared on the "withdrawal" list, respectively is Conba (600572.SH) are Zhejiang Pharmaceutical 600216.SH, Xianju pharmaceutical 002332.SZ, Lukang Pharmaceutical 600789.SH, Huarun Shuanghe 600062.SH, medicine shares 600511.SH, Jiangsu Wuzhong 600200.SH Jinling pharmaceutical 000919.SZ, Anke biological 300009.SZ, Gloria pharmaceutical 002437.SZ, the temple of heaven biological 600161.SH.
Chinese medicine in the announcement said, according to the requirements of the State Food and Drug Administration "on carrying out the drug clinical trial data for checking and verification work notice" (2015 No. 117) and based on the current situation and the problem of domestic clinical institutions, through clinical research institutions, contract research organizations, comprehensive companies to consider co-ordination, hierarchical location pharmaceutical product development system construction ideas, its subsidiaries and take the initiative to withdraw the application for registration of the drugs.
In August 2015, the State Council and the State Food and Drug Administration released the opinions on reforming the system of review and approval of drugs and medical devices, this is regarded as "New Deal" file is intended to achieve accelerated backlog documents audit, the enterprise should strengthen self audit objectives. Subsequently, CFDA carried out on-site verification of part of the application for drug registration, many pharmaceutical companies under pressure to withdraw the application.
December 31, 2015, CFDA announced last year, the last time the results of the self, that is, on the 154 companies to withdraw 224 drug registration application notice (2015 287th). According to the interface of news reporter to incomplete statistics, the 36 listed drug prices.
In addition to the already announced the company, 154 companies on the list also contains the following listing Corporation: Shijiazhuang Pharmaceutical Group (01093.HK), Northeast Pharmaceutical (000597.SZ), pharmaceutical (02877.HK), Shanghai Pharmaceutical (601607.SH), jumpcan (600566.SH), Heng Rui medicine (600276.SH), Yabang shares (603188.SH), Jinling Pharmaceutical (000919.SZ), Huadong medicine (000963.SZ), Hisun Pharmaceutical (600267.SH), Apeloa Pharmaceutical (000739.SZ), Zhejiang Pharmaceutical (600216.SH), asiapharm (02186.HK), Furen Pharmaceutical (600781.SH), grand Pharmaceutical (00512.HK), Taicheng Pharmaceutical (002728.SZ), the federal Pharmaceutical (03933.HK), Guilin Sanjin (002275.SZ), Winbond health (002004.SZ), Lummy Pharmaceutical (3000006.SZ), Yi Bai Pharmaceutical (600594.SH), foci Pharmaceutical (002644 .SZ).
The 21st Century Business Herald quoted informed sources said, "it is understood, at present and has withdrawn the pharmaceutical companies list did not disclose estimated eventually withdrew the number will be more than 80%, to be able to cross the border also 200 to a drug application." He believes that more than the self withdrawal of the destruction of the greater is the third batch of verification results, the fastest in early January will be announced, the latest conclusion of the latest spring festival.
In the previous batch. Self examination and verification, the Shanghai pharmaceutical, Boji medical (300404.SZ) and other dozens of listed pharmaceutical companies have been involved, financial and operating condition by varying degrees of impact. Shenzhen Stock Exchange had this inquiry Boji medicine, the company in reply said since the carry out self inspection work, in addition to the published not approved the application for drug registration and, according to the statistical caliber of the company, as of December 13, 2015, the project company as a contract research organization, application for registration of the drugs for the withdrawal of total 22, the project contract signing time interval for 2006 to 2013, the average amount of the contract involved about 150 million yuan.
If the company does not continue to declare or after the declaration shall not be approved, 22 projects of the future or to withdraw the Boji medical income difficult to continue. Reply also mentioned that currently in the trial (including self Directory Project) by the company as a contract research organization of projects about 35, the in the trial project still exist withdrawn.