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Supervisor section
The new medicine examination and approval of the clinical research
The examination and approval that new drugs produce
Clinical trial procedure
 
 
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Supervisor section

1 , Nation, the province class drug supervision, surveillance management bureau: Is comprehensive supervision, surveillance food, health care article, cosmetics in State Department safe management and the supervisor drugs to take charge of of keep belong to organization, be responsible for the research to the drug( include traditional Chinese drug material, traditional Chinese drug decoction pieces, Chinese patent medicine, the chemistry bulk drug, pharmaceutical product and its product, antibiotic, bio-chemical drug, biological products, examine a patient the drug, radiopharmaceuticals, narcotics, poisonous sex drug, psychotropic substances, medical treatment apparatus, health material, medicine packing material...etc.) and produce, circulate, use to carry on the administration supervision, surveillance and technical directors;Be responsible for the food, care the article, make up the comprehensive supervision, surveillance of safe management of article and organize to moderate the demulcent therapy, reconciliation to organize to evolve to check the place to the important trouble by law;Be responsible for the examination and approval that cares the article.

2 , The drug of the national drug supervision, surveillance management bureau reviews the center of 评 :Is the technique that the national food drug of the drug supervision, surveillance management bureau registers the management to review the section of 评 , register to manage for the drug scientific, the norm turns to provide the technique support.Be responsible for the drug registration that manages the bureau promulgation according to the national food drug supervision, surveillance etc. regulation, carry on the technique to review the remark to the relevant drug registration application.Other work that contract for job the national food drug supervision, surveillance management bureau hands over to do.

3 , The national drug supervision, surveillance management bureau drug attestation management center:Is the national drug supervision, surveillance management bureau to keep belong to organization.Cardinal job: Participate the establishment and revise 《 the drug is not clinical to study the quantity management norm 》 ( GLP), 《 the drug clinical trial quantity management norm 》 ( GCP), 《 Good Manufacturing Practice and Quality Control of Drug, GMP and QC of Drug 》 ( GMP), 《 the traditional Chinese drug material is to produce the quantity management norm 》 ( GAP), 《 the drug management quantity management norm 》 ( GSP) demulcent therapy, reconciliation 《 the medical treatment apparatus manufacture quantity management norm 》 ( the medical treatment apparatus GMP) and the implement way that it correspond. ……

4 , The Chinese drug biological product examination:Call the medium check, is the national drug supervision, surveillance management the bureau keep belong to unit, is the legal national drug biological product quantity tallest examination the demulcent therapy, reconciliation arbitrates the organization.

 
 
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