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Announcement of the State Food and Drug Administration on Revising the Instructions for Benzbromarone Oral Preparations (No. 150 of 2020)
Time of Update: 2021-07-07
In order to further protect the safety of public medication, the State Drug Administration has decided to revise the instructions for benzbromarone oral preparations .
Attachment: Requirements for the revision of the instructions for benzbromarone oral preparations State Food and Drug Administration December 29, 2020
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Announcement of the State Food and Drug Administration on the issuance of 3 supplementary inspection methods including the supplementary inspection method for auramine O inspection items in Fuke Tiaojing Tablets (No. 15 of 2020
Time of Update: 2021-07-07
According to the relevant provisions of the "Drug Administration Law of the People's Republic of China" and its implementation regulations, "Supplementary Inspection Method for Auramine O Inspection
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Announcement of the State Food and Drug Administration on the conversion of Banlangen chewable tablets to over-the-counter drugs (No. 130 of 2020)
Time of Update: 2021-07-07
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents .
Templates for non-prescription drug instructions State Food and Drug Administration November 23, 2020 Announcement No.
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Announcement of the State Food and Drug Administration on the cancellation of registration certificates for phenolphthalein tablets and phenolphthalein buccal tablets (No. 6 of 2021)
Time of Update: 2021-07-07
According to Article 83 of the "Drug Administration Law of the People's Republic of China", the State Drug Administration organized a post-marketing evaluation of phenolphthalein tablets and phenolphthalein lozenges.
Attachment: List of manufacturers of phenolphthalein tablets and phenolphthalein lozenges State Food and Drug Administration January 8, 2021 Annex to Announcement No.
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Announcement of the State Food and Drug Administration on abolishing the original "Administrative Measures for Communication and Exchange of Drug R&D and Technical Review" (No. 139 of 2020)
Time of Update: 2021-07-07
In accordance with the "Drug Administration Law" and the "Administrative Measures for Drug Registration", in order to improve the communication system, the Drug Evaluation Center of the State Drug Administration issued the "Administrative Measures for Communication and Exchange of Drug Development and Technical Review" on December 10, 2020 ( (2020 Circular No.
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Announcement of the State Food and Drug Administration on Revising the Instructions for Haloperidol Preparations (No. 40 of 2021)
Time of Update: 2021-07-07
The marketing authorization holder of this product shall submit a supplementary application for the revision of the label in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations and in accordance with the requirements for the revision of the label of haloperidol preparations (see attachment), before June 14, 2021 Report to the Drug Evaluation Center of the State Drug Administration or the provincial drug regulatory authority for the record .
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Announcement of the State Food and Drug Administration on Revising the Instructions for Suxiao Jiuxin Pills (No. 12 of 2021)
Time of Update: 2021-07-07
The marketing authorization holder of this product shall revise the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration" and the corresponding instructions for revision requirements (see appendix), and report to the provincial drug regulatory authority for record before April 13, 2021 .
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Notice of the Comprehensive Department of the National Food and Drug Administration on Strengthening the Quality Supervision of the Coronary Stents in the National Centralized Purchase of the National Drug Administration (2020) 10
Time of Update: 2021-07-07
3. Do a good job in the supervision and inspection of circulation and use links The provincial drug regulatory authorities urge and guide the drug regulatory departments in cities and counties to strengthen the supervision of circulation and use, and urge the delivery units of selected coronary stent products to strictly implement the requirements of medical device management quality management standards, and take effective measures to ensure that they are selected.
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National Food and Drug Administration: Effectively strengthen the strict supervision of online drug sales
Time of Update: 2021-07-07
On April 29, the State Food and Drug Administration organized a symposium on drug online sales supervision in Shanghai .
The meeting emphasized that online drug sales are a prerequisite for ensuring the safety and effectiveness of drugs.
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Notice of the State Food and Drug Administration on Regulating the Appointment and Use of Licensed Pharmacists in Pharmaceutical Retail Enterprises Guo Yao Jian Yao Guan (2020) No. 25
Time of Update: 2021-07-07
3. Effectively play the role of licensed pharmacists and continue to strengthen team building Practicing pharmacists in drug retail companies shall be responsible for the drug quality management of their companies, supervise the implementation of relevant laws, regulations and specifications for drug management; be responsible for prescription review and supervision of deployment, provide the public with reasonable drug use guidance and consulting services; be responsible for collecting and feeding back information on adverse drug reactions and other pharmacy Work .
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Announcement of the State Food and Drug Administration on the conversion of Beiqi tablets into over-the-counter drugs (No. 14 of 2021)
Time of Update: 2021-07-07
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents .
Templates for non-prescription drug instructions State Food and Drug Administration January 18, 2021 Announcement No.
doc of the National Medical Products Administration Announcement No.
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Notice of the State Administration of Market Supervision and other departments on the issuance of the "Guangdong-Hong Kong-Macao Greater Bay Area Drug and Medical Device Regulatory Innovation and Development Work Plan" State City Drug Administration [202
Time of Update: 2021-07-07
Please your province earnestly implement the "four strictest" requirements and steadily advance the Guangdong-Hong Kong-Macao Greater Bay Area Regarding work related to the innovation and development of drug and medical device supervision and development in the district, step up efforts to formulate relevant supporting systems for the "Plan", implement supervision responsibilities, strengthen main responsibilities, do a good job in risk management and control, adhere to the bottom line of safety, and earnestly safeguard the safety of people's medical equipment .
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The State Food and Drug Administration and the Israeli Ministry of Health signed the "Joint Statement of Intention for Cooperation in the Supervision of Drugs, Medical Devices, and Cosmetics"
Time of Update: 2021-07-07
Both parties have the responsibility to jointly implement the important consensus reached by the leaders of the two countries, and take the signing of the "Joint Statement" as an opportunity to further strengthen cooperation in the supervision of drugs, medical devices and cosmetics .
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Announcement of the State Food and Drug Administration on Resuming Imports of Faming Tablets from France's Lekang-Midelan Pharmaceutical Factory (No. 81 of 2020)
Time of Update: 2021-07-07
139), deciding to stop the import and sale of Faming Tablets And use, stop related registration matters .
After research, it is now decided to resume the import, sale and use of Faming tablets .
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Announcement of the State Food and Drug Administration on Pilot Use of Electronic Permits for Import and Export of Narcotic Drugs and Psychotropic Drugs (No. 148 of 2020)
Time of Update: 2021-07-07
In order to implement the important decision and deployment of the State Council on deepening the reform of "delegating management and service", optimizing the business environment, and advancing the "Internet + government service" work, and to provide enterprises with more efficient and convenient government services, it has been decided by research and since December 2020 Starting on the 31st, the trial use of electronic permits for the import and export of narcotic drugs and psychotropic substances has been announced.
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Announcement of the State Food and Drug Administration on the conversion of prescription budesonide nasal spray to over-the-counter drugs (No. 13 of 2021)
Time of Update: 2021-07-07
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents .
doc of the National Medical Products Administration Announcement No.
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Announcement of the State Drug Administration on Revising the Instructions of Joint Pain Relieving Ointment (No. 2 of 2021)
Time of Update: 2021-07-07
According to the evaluation results of adverse drug reactions, in order to further ensure the safety of the public use of drugs, the National Medical Products Administration has decided to uniformly revise the [Adverse Reactions], [Contraindications] and [Precautions] items of the joint pain relief ointment instructions .
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Announcement of the State Food and Drug Administration on the conversion of Jinzhen Granules and Fuke Baifeng Capsules to OTC (No. 3 of 2021)
Time of Update: 2021-07-07
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents .
Templates for non-prescription drug instructions State Food and Drug Administration January 7, 2021 Announcement No.
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Announcement of the State Drug Administration on Revising the Instructions for Dahuoluo Preparations (No. 1 of 2021)
Time of Update: 2021-07-07
All the marketing authorization holders of the above-mentioned drugs shall revise the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration" and the corresponding instructions for revision requirements (see appendix), and report to the provincial drug supervision and administration department for record before April 4, 2021 .
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The State Food and Drug Administration issued an announcement on protected varieties of traditional Chinese medicines
Time of Update: 2021-07-06
On May 26, the State Food and Drug Administration issued an announcement on protected varieties of traditional Chinese medicines .
will continue to be given 2 Level of protection, the protection period and the number of protected varieties are respectively May 06, 2021-May 9, 2027, ZYB20720200101 .
