Medicines and chemical reagents of food of each province, municipality, municipality directly under the Central Government controls management board (medicines and chemical reagents controls management board) :

New castigatory " medicines and chemical reagents registers administrative measure " (the following abbreviation is new " method " ) will apply at rising on October 1, 2007. Good to do new " method " carry out carry out, assure new old " method " transfer smoothly and join, inform concerned matters concerned as follows now:

One, supervisory management board of medicines and chemical reagents of food of each province, municipality, municipality directly under the Central Government wants to learn to publicize and be carried out seriously new " method " reach its relevant provision, unite a thought, improve knowledge, fulfil medicines and chemical reagents to register superintendency measure, cogent can accuse the safety that assures medicines and chemical reagents, effectively with quality, maintain public health.

2, had obtained before October 1, 2007 " clinical trial approves medicaments " breed, its are clinical experiment according to former " medicines and chemical reagents registers administrative measure " the requirement about clinical trial and " clinical trial approves medicaments " content undertakes. After clinical trial ends according to new " method " the regulation declares production.

3, the application that accepts before October 1, 2007 produces treat kind of high capacity to change medical injection, Chinese traditional medicine the breed of Gao Feng danger such as injection of injection, much constituent biochemistry, careful of national bureau medicines and chemical reagents judges a center to had finished technical careful to judge service medicines and chemical reagents to register department, register department to inform the applicant applies for to produce spot inspection by medicines and chemical reagents, tell management center of attestation of national bureau medicines and chemical reagents. Management center of attestation of medicines and chemical reagents of bureau of state of introversion of 6 months since the day that the applicant gets manufacturing site to check an announcement oneself puts forward to produce the application that the spot checks, management center of attestation of national bureau medicines and chemical reagents is after the application that receives manufacturing site examination, the organization produces a process to wait to sample batch undertake the spot is checked, affirm the manufactures technology feasibility of check and ratify, at the same time draw-out 1 batch of medicines and chemical reagents, send the medicines and chemical reagents that is in charge of check of standard of this medicines and chemical reagents to examine be examined.
The application that accepts before October 1, 2007 produces treat kind of high capacity to change medical injection, Chinese traditional medicine the high risk such as injection of injection, much constituent biochemistry breed, careful of national bureau medicines and chemical reagents judges a center to have not finish technical careful to judge, judge a center by careful of national bureau medicines and chemical reagents according to new " method " the requirement informs the applicant applies for to produce spot inspection.
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