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Notice on the public solicitation of recommendations and Chinese version of ICH S1B(R1): Carcinogenicity Research
Time of Update: 2023-02-02
S1B (R1) English version Center for Drug Evaluation, State Medical Products Administration December 22, 2022In order to promote the smooth implementation of the newly revised ICH guidelines in China, our center has formulated the implementation recommendations of "S1B(R1): Carcinogenicity Research" and organized the translation of Chinese editions.
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Guizhou issued a document clarifying the level of reimbursement for new crown treatment costs
Time of Update: 2023-02-02
"Guizhou Medical Insurance" WeChat public account news on January 8, according to the National Health Insurance Administration, the Ministry of Finance, the National Health Commission, and the Nation
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Paxlovid health insurance negotiations were unsuccessful and the drugs were reimbursed
Time of Update: 2023-02-02
On the 8th, after several days of "soul haggling", the negotiation of the 2022 national medical insurance drug catalogue officially ended. According to news from the National Health Insurance Adminis
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The traditional Chinese medicine tablet industry is accelerating the realization of the traceability system, and pharmaceutical equipment will be promising
Time of Update: 2023-02-02
Recently, the State Food and Drug Administration issued Several Measures on Further Strengthening the Scientific Supervision of Chinese Medicines and Promoting the Inheritance, Innovation and Develop
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CDE is publicly soliciting comments on the Guidelines for Natural History Research of Diseases in Drug Development for Rare Diseases
Time of Update: 2023-02-02
Annex 2 "Guidelines for Natural History Research of Diseases in the Development of Rare Disease Drugs (Draft for Comments)" feedback form .
Annex 2 "Guidelines for Natural History Research of Diseases in the Development of Rare Disease Drugs (Draft for Comments)" feedback form .
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$155 million, Pfizer joins hands with LianBio! Why is the RSV space attracting giants?
Time of Update: 2023-02-02
On December 19, Pfizer and LianBio announced that Pfizer will exercise its option to acquire the development and commercialization rights of respiratory syncytial virus (RSV) therapeutic candidate, s
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Recently, there has been good news that generic drugs of pharmaceutical companies have been evaluated and approved for the first generics
Time of Update: 2023-02-02
Recently, Hanyu Pharmaceutical issued an announcement that the company received the "Drug Registration Certificate" issued by the State Medical Products Administration, and the company's hypoglycemic drug "vildagliptin tablets" was approved for marketing and deemed to have passed the consistency evaluation.
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The State Food and Drug Administration announced on the approval and registration of 339 medical device products
Time of Update: 2023-02-02
, Ltd National Arms Note 20223401587 18 Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) Jiangsu Meike Medical Technology Co.
, Ltd National Arms Note 20223401587 18 Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) Jiangsu Meike Medical Technology Co.
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What are the adjustments to the 10th edition of the prevention and control plan? Official details
Time of Update: 2023-02-02
diseases The plan also mentions that the immunization strategy will be further improved according to the progress of vaccine research and development and the results of clinical trials.
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In 2023, a number of potential new drugs are coming: GSK, Eli Lilly, Roche, AZ/Daiichi Sankyo ... Hurry up
Time of Update: 2023-02-02
In addition, in the same month, Eli Lilly also announced the results of the Aduhelm head-to-head trial with Biogen/Eisai, and the Phase III clinical study TRAILblazer-ALZ 4 of Donanemab for the treatment of early AD met all primary and secondary endpoints in a 6-month analysis.
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【Data analysis】The total amount of chromatography won in December exceeded 80 million, a year-on-year increase of 268%
Time of Update: 2023-02-02
From the perspective of the winning brand of chromatography According to the statistics that can be counted, a total of 20 brands competed in the market in December, including domestic brands Qingdao Shenghan, Shanghai Tongwei, Hexin Instrument, Pannuo, Chuangxin GM, imported brands Agilent, Shimadzu, Thermo Fisher, Waters, Metrohm and so on.
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Important adjustments! The new version of the new coronavirus infection diagnosis and treatment plan was announced
Time of Update: 2023-02-02
Interpretation of the "Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial Version 10)" In order to further do a good job in the medical treatment of new coronavirus infection and eff
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How to relieve the discomfort after "Yangkang"? Official detailed explanation of the 10th edition of the diagnosis and treatment plan
Time of Update: 2023-02-02
In terms of clinical treatment, the National Health Commission fully draws on the valuable experience gained in the past three years: first, strengthen the forward movement of the threshold; the second is to further standardize the treatment of severe diseases; The third is to adhere to the integration of traditional Chinese and Western medicine; The fourth is to further strengthen the concept of co-treatment of new coronavirus infection and underlying diseases.
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Domestic ECMO successfully approved for listing! The domestic high-end medical equipment industry is ushering in a new breakthrough
Time of Update: 2023-02-02
The first domestic ECMO was successfully developed Extracorporeal membrane oxygenation system (ECMO) is a key medical equipment for the treatment of acute respiratory failure, cardiopulmonary failure and other patients, mainly used to provide long-term extracorporeal cardiopulmonary support for patients with cardiopulmonary failure, assist breathing and blood circulation, and maintain the life of patients.
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Notice of the Center for Drug Review of the State Food and Drug Administration on the issuance of the "Technical Guidelines for the Research of Prescription Drugs of the Same Name (Trial)" (No. 48 of 2022)
Time of Update: 2023-02-02
pdf Notice of the Center for Drug Review of the State Food and Drug Administration on the issuance of the "Technical Guidelines for the Research of Prescription Drugs of the Same Name (Trial)" (No. 48 of 2022)Release date: 20221227 Under the deployment of the State Medical Products Administration, the Center for Drug Review organized and formulated the Technical Guidelines for the Research of Prescription Drugs of the Same Name (Trial) (see Annex).
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The National Drug Supervision and Administration Work Conference was held in Beijing
Time of Update: 2023-02-02
On January 5, the National Drug Supervision and Administration Work Conference was held in Beijing. The meeting was guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Er
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From Baekje, Junshi and Shinda to Shiyao, Qilu, and Kelun, "Hundred Enterprises and Thousands of Antibodies" find the way and "a hundred flowers bloom"! High-value innovation overcomes difficulties
Time of Update: 2023-02-02
With the prominent effect of biological products in the field of anti-tumor, the amazing therapeutic effect of macromolecular biological drugs, major pharmaceutical companies have frantically poured
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Notice on the public solicitation of comments on the Catalogue of Reference Preparations for Chemical Generic Drugs (65th Batch) (Draft for Comments).
Time of Update: 2023-02-02
Center for Drug Evaluation, State Medical Products Administration December 29, 2022 Related attachments serial number Attachment name 1 The Catalogue of Reference Preparations for Chemical Generic Drugs (Batch 65) (Draft for Comments) .
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In 2023, the traditional Chinese medicine formula granule industry will face stricter supervision, forcing enterprises to standardize their development
Time of Update: 2023-02-02
Recently, the State Food and Drug Administration issued "Several Measures on Further Strengthening the Scientific Supervision of Chinese Medicines and Promoting the Inheritance, Innovation and Develo
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Note! There are significant changes to the CDE submission of supplementary information!!!
Time of Update: 2023-02-02
Chapter III Procedures for formal issuance, supplementary consultation, and objection Article 8 If it is necessary for the applicant to supplement new technical information on the basis of the original declaration materials during the review process, combined with the response to the "professional review inquiry letter", according to the "Measures for the Administration of Drug Registration", the drug review center shall in principle submit a request for supplementary information, after listing all the questions.
