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Supervisory management board of national provision medicines and chemical reagents is held on December 8, 2008 in December routine press conference, news spokesman Yan Jiangying reports our country the relevant case that farther perfect a shot in the arm supervises lasting effect mechanism and circumstance of examination at random of quality of near future medicines and chemical reagents, answer the reporter asks. Chinese net undertakes spot direct seeding.
On the news briefing, the reporter asks, sino-US December last year both sides was signed " agreement of cooperation of security of medical devices of medicines and chemical reagents " , after passing one year, the progress that Sino-US both sides works on consultative foundation how? The answer says news spokesman Yan Jiangying, last year on December 11, the FDA that the human health of supervisory management board of national provision medicines and chemical reagents and United States serves ministry subordinate was signed Sino-US " the agreement about safety of medical devices of medicines and chemical reagents " , this agreement was signed already near one year, in time of near one year, supervisory management board of national provision medicines and chemical reagents and American FDA were begun jointly a series of the job, basically be the following respects: It is national provision medicines and chemical reagents supervised management board to establish group of an executive leader and working party technically, and this year March, sino-US two countries held first time to carry out the conference in Beijing again, bat around the agreement of Sino-US two countries is carried out circumstance and evaluated a few issues. According to consultative requirement, medicines and chemical reagents of food of Sino-US two countries superintends a branch also crossing-over the enrollment of medicines and chemical reagents and medical devices data. 2 it is the agreement that supervisory management board of national provision medicines and chemical reagents signs according to Sino-US two countries, to the production of designation product the enterprise undertook registering, so that comprehensive understanding assigns product production and exit case. Specific content is among this agreement, the press conference that will hold on December 12 last year also was announced, the face has the breed of 8 medicines and chemical reagents and 2 variety of medical devices here. 3 it is the regulation according to the agreement, supervisory management board of national provision medicines and chemical reagents released October this year " the announce that carries out catalog management about exporting medicines and chemical reagents and production of medical devices to the part " , also announced exit medicines and chemical reagents and medical devices to superintend the catalog of breed between this announce at the same time. First among breed catalog, also announced the raw material medicine of 9 kinds of medicines and chemical reagents and preparation, and the breed of two medical devices. Everybody can control management board in national provision medicines and chemical reagents medicine of raw material of these 9 kinds of medicines and chemical reagents and preparation are obtained on the website, and the name of breed of two kinds of medical devices. Production " breed catalog " such exit medicines and chemical reagents produces a business, ought to apply for about the regulation according to the supervisory management of medicines and chemical reagents and obtain " medicines and chemical reagents produces licence " , according to medicines and chemical reagents registers concerned regulation of management, the enrollment that must obtain drug article date. The manufacturing company of medicines and chemical reagents must administer normative concerned regulation according to quality, want to apply for to obtain letter of GMP of medicines and chemical reagents, should obtain by the regulation before exit " medicines and chemical reagents sells certificate " . Production " breed catalog " the export business when appliance of cure of doctor of traditional Chinese medicine, also ought to monitor concerned regulation of management according to medical devices, application is obtained " medical devices produces licence " , and register concerned regulation of management according to medical devices, apply for and obtain medical devices to register certificate, after gaining relevant certificate and competence only, just can produce outcome these " breed catalog " the medicine of raw material of medicines and chemical reagents in the center and preparation. Yan Jiangying says, among this announce, supervisory management board of national provision medicines and chemical reagents was released on October 17, 2008 " carry out catalog government announcement about exporting medicines and chemical reagents and production of medical devices to the part " later, the requirement is produced inside 2 years or accept manufacturer of the pharmacy outside the condition to commend the company that breed exports inside treatment breed catalog, should clutch deal with a moment ago the matters concerned of these application of my respecting. The short of inside two years the enterprise of afore-mentioned requirements, must not be produced and sell the exit variety inside breed catalog. Yan Jiangying expresses, everybody also knows, the safety of medicines and chemical reagents is a global problem, safety of medicines and chemical reagents does not have national boundaries, collaboration is only alternative. In national provision medicines and chemical reagents supervisory management board and American FDA were signed " medicines and chemical reagents and agreement of medical devices " come near one year, we were begun a series of the job, in the meantime, national provision medicines and chemical reagents supervised management board to also establish good cooperative mechanism with other a few countries and area, the supervisory government that begins a few medicines and chemical reagents and medical devices jointly works, and extensive international collaboration and communication. Yan Jiangying expresses, national provision medicines and chemical reagents supervises management board and American FDA today, include an European Union, still international person coordinates an organization to holding the attestation of the GMP of a medicines and chemical reagents to groom with medicines and chemical reagents, greeting media also understands us to concern groomed job. This year this year, supervisory management board of national provision medicines and chemical reagents is returned and person of England, Australia, Singapore, Canada, Japan, Korea, Russia, Spain, European Union, World Health Organization, international coordinates check of medicines and chemical reagents of organization, international to cooperate with medicines and chemical reagents country and the area such as the organization began extensive collaboration and communication, our purpose is to be faced jointly science and technology changes increasingly now, relatively insufficient labor power and financial capacity resource, and product globalization situation superintends brought challenge to food medicines and chemical reagents, everybody joint efforts, those who defend global public with medicine and dietary safety. (Fan Xiao)
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