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In order to accelerate transformation, traditional pharmaceutical companies and Biotech cooperation mergers and acquisitions have become the norm!
Time of Update: 2023-02-02
js?cdnversion='+~(-new Date()/36e5)];Recently, another traditional pharmaceutical company and Biotech announced a merger and acquisition!
js?cdnversion='+~(-new Date()/36e5)];Recently, another traditional pharmaceutical company and Biotech announced a merger and acquisition!
js?cdnversion='+~(-new Date()/36e5)];Recently, another traditional pharmaceutical company and Biotech announced a merger and acquisition!
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The Anhui Provincial Food and Drug Administration issued the implementation rules for the grading supervision of medical device production
Time of Update: 2023-02-02
Recently, the Anhui Provincial Food and Drug Administration took the lead in promulgating the Implementation Rules for the Graded Supervision of Medical Device Production in Anhui Province (hereinaft
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The "first" new drug approved by the FDA in 2022: involving TCR therapy, fecal bacterial therapy, bispecific antibodies, gene therapy, etc
Time of Update: 2023-02-02
6. Tecvayli(teclistamab) In November 2022, the FDA approved Tecvayli for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who had previously received 4 or more lines of therapy (including proteasome inhibitors, immunomodulators, anti-CD38 monoclonal antibodies).
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The key points of quality system construction based on "MAH Implementing the Provisions on the Supervision and Management of Drug Quality Subject Responsibility"
Time of Update: 2023-02-02
Quality Assignee's responsibilities and requirements Pharmacy or related professional background, bachelor degree or above or intermediate or above professional and technical title or licensed pharmacist qualification, more than five years of practical experience in drug production and quality management, engaged in drug production process control and quality inspection, familiar with relevant laws, regulations and rules and regulations of drug supervision and administration.
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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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Notice of the Center for Drug Evaluation of the State Medical Products Administration on publicizing the list of clinical external experts for technical review of children's medication
Time of Update: 2023-02-02
Notice of the Center for Drug Evaluation of the State Medical Products Administration on publicizing the list of clinical external experts for technical review of children's medicationRelease date: 2
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【Announcement】Notice on updating the batch electronic signature software for PDF files
Time of Update: 2023-02-02
Center for Drug Evaluation, State Medical Products Administration January 3, 2023 In order to ensure the smooth implementation of the electronic declaration of drug registration applications and the steady progress of eCTD, and better serve applicants, our center has optimized and updated the batch electronic signature software of PDF files after full evaluation based on the feedback collected recently by the industry, so as to further improve the efficiency of electronic signature of PDF files and improve user experience.
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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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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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【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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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.
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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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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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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 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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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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NMPA issued the "MAH Quality Subject Responsibility Management Regulations", which will come into force on March 1, 2023!
Time of Update: 2023-02-02
On December 29, the State Food and Drug Administration officially issued the Provisions on the Supervision and Administration of Drug Marketing Authorization Holders to Implement the Subject Responsi
