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On June 7, the State Drug Administration announced that at 1: 30 p. m. local time on June 7, Japan, at the first meeting of the International Technical Coordination Committee for Registration of Human Drugs (ICH)2018 held in Kobe, Japan, the State Drug Administration of China was elected as a member of the ICH Management Committee.
After the vaccine storm, how to go the road of medical reform?
The "accountability storm" of Changchun Changsheng vaccine incident has swept across the country. The handling of relevant responsible persons from top to bottom involves a wide range and intensity, which is unprecedented. It is undoubtedly a "super typhoon" in the pharmaceutical industry. It also demonstrates the attitude and determination of the central government to the "four strictest" and "four have two responsibilities" in food and drug supervision. We have reason to believe that, this storm will also have a profound impact and positive significance on the future food and drug supervision!
On July 30, the General Administration of Market Supervision held a party group (enlarged) meeting to convey and study the spirit of General Secretary Xi Jinping's important speech on inspection work, and special research and deployment of the 11th inspection team of the Central Committee to inspect the feedback and rectification work of the original Food and Drug Administration. The meeting was presided over by Bi Jingquan, Secretary of the Party Leadership Group and Deputy Director of the General Administration.
On the afternoon of July 23, the State Food and Drug Administration held an enlarged meeting of the party group to convey and study the spirit of General Secretary Xi Jinping's important instructions on the Changchun Changsheng vaccine case in Jilin, and to study and implement measures. Li Li, secretary of the party leading group and deputy director, presided over the meeting, attended by Xu Jinghe, member of the party leading group and deputy director, Jiao Hong, director of the bureau, and responsible persons of relevant departments and bureaus of the bureau.
On June 26, the China Pharmaceutical Packaging Association and his party visited the small animal husbandry factory of Japan CKD Co., Ltd. and the Chinese and foreign pharmaceutical Fujiozhi factory. Japanese personnel warmly introduced the company and the factory to the association and his party, and then the two sides had cordial exchanges. Relevant persons in charge of our technology research and development department and quality control department participated in this activity.
According to the "Decision of the State Council on Canceling a Batch of Administrative Licensing Matters" (Guo Fa [2017] No. 46, hereinafter referred to as Document No. 46), and the former State Food and Drug Administration "Regarding the Adjustment of the Review and Approval of Raw Materials, Pharmaceutical Accessories and Pharmaceutical Package Materials Announcement (2017 No. 146, hereinafter referred to as Announcement No. 146), in order to regulate the import customs clearance of raw materials and pharmaceutical excipients, the relevant matters are hereby announced as follows:
In order to implement the Opinions of the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices (HJ [2017] No. 42) and the Decision of the State Council on Canceling a Batch of Administrative Licensing Items (GF [2017] No. 46), and cancel the approval of pharmaceutical excipients and packaging materials and containers that directly contact with drugs (hereinafter referred to drug packaging materials), raw materials, pharmaceutical excipients and pharmaceutical packaging materials shall be reviewed and approved together with the application for registration of pharmaceutical preparations. The relevant matters are hereby announced as follows:
Questions and answers on the related review of drug packaging materials and excipients
Accessories are produced in the United States and have not been registered in China. How should they be operated? What materials should be submitted? How long can I get the approval?
Contact Information
Telephone:0712-3246096
Sales:0712-3222046/3245368
Address: 2 South Stadium Road, Economic and Technological Development Zone, Yingcheng City, Hubei Province
Sales/after-sales person in charge:13607293339(Director Wang)
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