The Specific Regulation on Doping by the State Food and Drug Administration

June 19th, 2008 - 12:41 pm ICT by admin  

The Chinese Government attaches great importance to anti-doping work; the State Council has devoted special efforts to the deployment of doping, and set up the leading group for doping control involved by eight organizations, such as, State Food and Drug Administration, Ministry of Public Security, Ministry of Industry and Information, Ministry of Health, State Administration for Industry and Commerce, China Customs, General Administration for Sport of China, the Beijing Organizing Committee for the Games of the XXIX Olympiad (BOCOG), to conduct special management action on production and distribution of doping.

First, Joint -Management, Multi-Sectoral Joint Doping Campaign

Eight organizations jointly issued the special management action program on the manufacturing and distribution of doping, according to responsibilities and duties of each organization, to conduct information sharing, joint inspection and parallel investigations, each organization in accordance with the program of special efforts form the work mechanism of a joint participation, division of collaboration, and co-ordination. At present, all works go well according to work plan assigned by each organization.

Second, the Measures of the Doping Control are Effective for the Drug Production and Sales Enterprises

On the basis of joint special management of protein assimilation preparations and peptide hormones in the second half of last year, the State Food and Drug Administration set up the Implementation Plan for Special Management of Production and Distribution of Doping, sternly issued the notices of investigate and punish acts of illegal production and distribution, clearly indentified requirements of five “if any” and five “shall be”: If any enterprise that drug has not obtained the approval document but illegally produce and sell in market, the Drug Manufacturing License shall revoked; if any enterprise that drug has obtained the approval document but illegally produce and sell in market the drug’s approval documents shall be withdrew, up to that the Drug Manufacturing License shall be revoked; if any enterprise without authorization but illegally does pharmaceutical wholesale business, the Pharmaceutical Trade License shall revoked; if any as appointed pharmaceutical wholesale enterprise purchase and sell drugs without according to relevant regulation, the Pharmaceutical Trade License shall be revoked; if any pharmaceutical retail enterprise engages in business of protein assimilation preparations and peptide hormones except insulin, the Pharmaceutical Trade License shall be revoked.

To further implement the responsibility of governance, and increase the intensity of training, we also adopted the following measures: First, to implement the responsibility system. State Food and Drug Administration and the provincial food and drug administrations have signed letters of responsibility. Second, to accredit the inspectors into more than 80 pharmaceutical enterprises that produce protein assimilation preparations and peptide hormones, they have all arrived before April 30th. Third, to do inspection check in relevant pharmaceutical manufactures, wholesales and retails. 4 To organize the manufacturing enterprises of protein assimilation preparations and peptide hormones to launch the initiatives for strict self-discipline. Fifth, to organize the activities of anti-doping promotion, promotion week, display panels and posters in retail pharmacies and so on. Sixth, to require a warning sign of Athletes Caution on all drugs containing doping, all drugs produced after the 1st of October in 2007 but without this sign shall be taken off.

As of May 31, 2008, all levels food and drug agencies have conducted inspection check to national wide protein assimilation preparations and peptide hormones enterprises, pharmaceutical wholesale enterprises with business license of protein assimilation preparations and peptide hormones and all pharmaceutical retail pharmacies. In mid-May, we conducted comprehensive inspection checks and unannounced visits to six cities of Olympic event contractors, the inspection results show that the pharmaceutical manufacturing enterprises, wholesale enterprises, retail pharmacies have basically reached a doping control requirements for the work.。

Third, to Punish Severely, and Resolutely Investigate and Deal with Illegal Production and Distribution of Doping Cases

Since the development of special management action, various organizations have coordinated and severely punished illegal production and distribution of doping cases. Since the second half of last year until now, it has been found that 23 chemical enterprises in illegal production and distribution of protein assimilation preparations and peptide hormones, and have been ordered to stop production and distributions; 125 illegal production and distribution enterprises have found (93 of all were retail pharmacies) and 3 manufacturing enterprises who have conducted illegal activities have been stopped producing relevant drugs, Pharmaceutical Trade Licenses of 18 pharmaceutical distribution enterprises have been revoked, the administrative punishments have been implemented to other illegal pharmaceutical production and distribution enterprises according with laws; 321 websites that illegally released the information of the protein assimilation preparations and peptide hormones selling have been analyzed and dealt with.

Fourth, Work Plan for Next Step

We must further intensify efforts to make special management action of doping: First, eight organizations will focus on emphases supervision of doping control work, led by head of each organization to six cities of Olympic event contractors and some provinces (autonomous regions and municipalities) at the end of this month to early next month. Second, to investigate openly and secretly, severely punish illegal cases, intensify investigation and handling to illegally manufacturing and distributing doping, all confirmed illegal acts will be strictly and severely punished in accordance with the law. Third, the Notice for Announcing Telephone Hotlines of Special Management of Doping will be jointly released, promulgating the telephone number and email address. Fourth, for theses cases of illegally producing and distributing the doping, once confirmed and verified, should be exposed in public.

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