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Circular of the General Administration on the Publication of Information Requirements for the Declaration of Pharmaceutical Excipients for Pharmaceutical Packaging Materials (for Trial Implementation) (No. 155 of 2016)
According to the Announcement on Matters Relating to the Review and Approval of Pharmaceutical Packaging Materials and Pharmaceutical Excipients Associated with Drugs (No. 134 of 2016 by the State Food and Drug Administration), I have organized the formulation of the Requirements for Reporting Information on Pharmaceutical Packaging Materials (for Trial Implementation) and Requirements for Reporting Information on Pharmaceutical Excipients (for Trial Implementation), which are hereby promulgated, and the relevant matters are notified as follows:
A, drug packaging materials, pharmaceutical excipients have been associated with the drug clinical trial application declaration, such as changes in the drug marketing application stage, drug packaging materials, pharmaceutical excipients manufacturers should promptly notify the applicant for drug registration, and directly to the State Food and Drug Administration Drug Review Center to submit relevant additional information, with drug packaging materials, pharmaceutical excipients, "Notice of Acceptance", no need to repeat the associated declaration.
Second, pharmaceutical packaging materials, pharmaceutical excipients manufacturer name, production address, prescription process, quality standards and other changes, its manufacturers should carry out research and timely notification of relevant drug manufacturers. Drug manufacturers should keep abreast of changes in drug packaging materials, pharmaceutical excipients, and research and evaluation in accordance with the relevant technical guidelines, the quality of drug packaging materials, pharmaceutical excipients changes should be based on the "Drug Registration and Administration" of the relevant provisions of the declaration of drug supplement applications, the quality of drug packaging materials, pharmaceutical excipients changes should be based on the "Drug Registration and Administration" Annex 4 Supplementary Application No. 36 Item 36 to the provincial food and drug regulatory authorities for the record.
Third, the applicant for drug registration in the drug registration information submitted together with drug packaging materials, pharmaceutical excipients research information, drug review can be completed, after the completion of the review of drug packaging materials, pharmaceutical excipients are not issued an approval number.
4. This circular shall come into force on the date of its publication.
This circular is hereby notified.
Annex: 1. Information requirements for the declaration of pharmaceutical packaging materials (for trial implementation)
2. Information requirements for the declaration of pharmaceutical excipients (for trial implementation)
3. Declaration form for the development of pharmaceutical packaging materials and pharmaceutical excipients
4. Site Verification Report Form for Pharmaceutical Packaging Materials and Pharmaceutical Excipients
General Administration of Food and Drug Administration
23 November 2016
See link for annex information:
http://www.sda.gov.cn/WS01/CL0087/166791.html
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The sun and the moon have opened a new year, and there is another spring in heaven and earth. On the occasion of the Chinese New Year, Jiyuan Yaohui Glass Products Co., Ltd. would like to extend our most cordial condolences and best wishes to the managers at all levels who are responsible and active in taking the lead, to the staff who have been working hard and selflessly in the front line, to the families who have been silently and fully supported the work of the staff, and to the friends from all walks of life who have been caring and supporting the construction and development of Jiyuan Yaohui Glass Products Co. Sincere wishes! The past year was an extraordinary year in the development history of Jiyuan Yaohui Glass Products Co. In this year, the achievements made were remarkable, and the development of the company, the momentum is good. The achievements of the past year were not easy to come by. These achievements were made possible by the kind care of leaders at all levels, by the strong support of the community and by the hard work of all staff! Here, Jiyuan Yaohui Glass Products Co., Ltd. extends its highest respect and most heartfelt thanks to all of you! On the occasion of welcoming the new year, let us join hands, overcome difficulties, forge ahead and keep up with the times, cherish the achievements we made yesterday and grasp the opportunity today to meet the brilliant future of Jiyuan Yaohui Glass Products Co. We wish you all good health, family happiness, all the best, and a happy New Year!
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Watched an educational film on the topic of work safety
We are dedicated to providing a professional, high quality and efficient service to our customers.
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E-mail: yhbl@jyyhbl.com
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