About to do a good job of drug approval and registration review of supplementary notice
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The drug safety note [2010] no. 2010
Published September 29, 2010
Various provinces, autonomous regions and municipalities directly under the food and drug administration (fda) :
For further chemical and biochemical medicine injections of multicomponent registration again, by the provincial bureau of injection and the progress of the registration and the feedback analysis, combined with "about release chemical injection and biochemical medicine injection basic technical requirements of multicomponent notice food drug safety note [2008] no. 7 (countries) (hereinafter referred to as the no. 7) the relevant requirements, are about to do a good job of drug approval and registration review notice food drug safety note [2009] no. 387 (countries) supplementary notice is as follows:
A, a chemical injection therapy of large capacity and multicomponent biochemical medicine injection should be according to the degree of risk, in the further scrutiny in the registration process. Involve issues of pharmaceutical dosage forms, specifications can be combined with the adverse drug reaction monitoring and drug evaluation work again.
On the injection drug production technology and prescription verification work notice (the food drug safety office [2007] no. 504) listed in annex 1 of high-risk species, should be key to review in the registration again.
Second, a chemical injection to the therapy of large capacity and multicomponent biochemical medicine injection:
1. According to the requirements of article 7 not to carry out the research work, will not be registered again;
2. Has to carry out the research work and to complete at least the aseptic process validation and key quality control program (such as the material, pyrogen, etc.), to prove its safety risk control, can be first to register again, but should be completed within 1 year in the approval documents require companies that 7 of the rest of the work.
Three, in addition to the treatment of large capacity chemical injection and biochemical medicine injection outside of multicomponent varieties:
1. Have been submitted according to the article 7 research materials, shall be registered again;
2. According to the request for the submission of a complete research materials, can be first to register again, but should be within 1 year in the approval documents require companies to complete the work required by the no. 7.
For aseptic security level F0 value < 8, and the aseptic process validation research materials shall be submitted at least within 1 year in the approval documents require companies to complete the rest of the work;
The aseptic security level F0 value < 8 and fails to submit the aseptic process validation studies, will not be registered again.
Four, the pharmaceutical supervisory and administrative departments at the provincial level for approval documents registered again in that time limit to complete the corresponding work of varieties should be timely reports summarize the country, the approval documents and the tracking and urge enterprises to finish within the time limit stipulated by the corresponding work. Fails, pharmaceutical supervisory and administrative departments at the provincial level shall order the enterprise to register again and suspend production, approval documents will report opinion, country at the same time, by the country shall be published on the website. Country according to the opinion of the pharmaceutical supervisory and administrative departments at the provincial level may not be registered again notice.
The state food and drug administration
On 29 September 010
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