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| Related advisory services for further strengthening of conformity assessment |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-30 10:03:09 Number Browse：762 |
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Medical network on August 30 - to further implement the state council general office on the evaluation opinions of generic quality and curative effect of consistency "(guo fa [2016] no. 8) related work requirements, strengthen consulting service work, since August 25, 2017, human medicinal center service hall reception and arrangement of personnel in the administration of administrative processing solution consistency evaluation related issues.The notice of the relevant advisory services on further strengthening of conformity assessment of the pharmaceutical audit center has been announced as follows (see annex).
Annex: notice of further strengthening of the consistency evaluation related advisory service work
The state administration of food and drug administration accepts the service hall
August 29, 2017
Notice of further strengthening of the consistency evaluation related advisory service work
According to the general office of the state council about to carry out the quality of generic drugs and curative effect evaluation of consistency views "(guo fa [2016] no. 8) administration of spirit and work requirement, in order to further strengthen the consistency evaluation related consulting service work, solve in the consistency of the problems in the evaluation of enterprises, to accelerate the process of consistency evaluation work, now just informing related consulting work matters as follows:
One, the CDE website opens the conformity evaluation work network consultation column
Relevant enterprises and units by CDE website "window of the applicant" in the "general technical problems consulting platform" column consistency evaluation policy and technical consultation questions, I will promptly reply to the applicant within 15 working days.Enterprises and units that have not opened the "window of applicants" may submit questions by E-mail, contact: li yiyun;Email address: liyy@cde.org.cn.
2. Provide on-site consultation service every Wednesday
From now on, every Wednesday ZiXunRi I will arrange personnel receive and answer consistency evaluation related issues, consulting site for administrative processing, xuanwu gate west street, xicheng district of Beijing dacheng square consistency evaluation information desk service hall.
Issue common problems and solutions on a regular basis
To the applicant through the network consultation platform and on-site consulting questions on Wednesday, I will be timely, regularly released in CDE website "hot spots" consistency evaluation related to the common problems and solutions.
Holding public expert consultation on major issues
For consistency evaluation of major difficult technical problems, I will be held in a timely manner the expert consultation, public invite related businesses, form a unified treatment principles and technical standards, and shall be made public.
5. Regularly hold training sessions on generic technology issues
Our office will regularly review the common problems of wide range and high technical difficulty, conduct regular training, and serve the enterprises in conformity assessment.
I inform you that.
Generic drug quality and efficacy consistency evaluation office
August 25, 2017
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