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Registration application for additional information exceeded the time limit? NMPA: It can be extended
Time of Update: 2022-10-19
3. For drug registration applications issued by the Drug Review Center of the State Food and Drug Administration from the date of this announcement to December 31, 2022, the time limit for supplementary information is extended to 160 working days.
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The treatment of chronic myeloid leukemia breaks through the dilemma of drug resistance, and the Handbook of Return to Society helps patients return to formal life
Time of Update: 2022-10-01
" Professor Hu Yu of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology emphasized: "I hope that through this conference, more people will have a deeper understanding of CML, be familiar with the current situation of CML diagnosis and treatment, and walk into the CML patient group to help patients re-create social value in the process of helping patients return to normal life.
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Announcement of the State Food and Drug Administration on the cancellation of 42 drug registration certificates such as glucose injection (No. 83 [2021
Time of Update: 2022-10-01
In accordance with the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Measures for the Administration of Drug Registration, the State Drug Administration decided to cancel 42 drug registration certificates such as glucose injection.
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What clinical data do I need to provide for the first clinical application of an innovative drug
Time of Update: 2022-05-26
For the organization of CTD general technical documents, on the basis of clinical review, clinical summary, and clinical report, the content can be specific to the development plan (may include Phase I~III), development path, and development time in the clinical trial plan; clinical research plan Dose selection basis (including starting dose, maximum tolerated dose, grouping, dose escalation), blinding (including unblinding, evaluation indicators, subject selection), safety/tolerability evaluation, data analysis, adverse events , ethics, etc.
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Nearly 30 dosage forms of Sunshine Procurement will be listed on the Internet
Time of Update: 2022-05-01
On March 4th, the Jiangsu Provincial Public Resource Trading Center issued a notice on the announcement of products to be listed on the Internet for the purchase of drugs by Sunshine.
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Genting Xinyao Trodelvy Approved in Singapore for Second-Line Treatment of Metastatic Triple-Negative Breast Cancer
Time of Update: 2022-03-09
In addition to Singapore, the relevant regulatory agencies in Greater China and South Korea have accepted relevant review applications for Trodelvy for the treatment of unresectable patients who have received at least two prior systemic therapies, at least one of which is for metastatic disease.
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China's emergency approval of Pfizer's new crown oral drug: indications, contraindications, clinical trials
Time of Update: 2022-03-08
In stark contrast to the delay in approving the mRNA vaccine BNT162b jointly developed by Pfizer/BioNTech, the State Drug Administration of China issued an emergency conditional approval on February 11 for Pfizer's Covid-19 prescription drug naimatevir/ritonavir (nirmatrelvir/ritonavir) tablets (trade name Paxlovid), at this time only 50 days have passed since the U.
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Drug treatment of ulcerative colitis: a list of recommendations in the 2021 ECCO guideline
Time of Update: 2021-11-14
Recommendation 12: For moderate to severe UC patients who do not respond well or intolerant to conventional treatments, it is recommended to use anti-tumor necrosis factor (TNF) drugs (infliximab, adalimumab, and golimumab) for induction Remission (strong recommendation; moderate quality of evidence) .
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Supercomputer reveals how the X chromosome is folded and inactivated
Time of Update: 2021-10-19
"This is the first time we have been able to simulate all RNA that spreads around chromosomes and shuts them down," said a visiting scientist at Los Alamos National Laboratory, Massachusetts General Hospital and Harvard.
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Kinetisol? technology broadens the preparation space and analyzes its application in the preparation of pharmaceutical amorphous solid dispersions
Time of Update: 2021-10-11
The exposure time of the material under high temperature is usually less than 5 seconds, such as When Kinetisol is used to prepare amorphous solid dispersions of itraconazole, the heating time and amount of heat are significantly lower than that of hot melt extrusion technology, as shown in Figure 3.
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Chinese medicine acyclovir for injection passed the consistency evaluation of generic drugs
Time of Update: 2021-06-06
The sales revenue of this drug in China Pharmaceuticals in 2020 is approximately RMB 2.
The sales revenue of this drug in China Pharmaceuticals in 2020 is approximately RMB 2.
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Hisun Pharmaceutical: Epirubicin Hydrochloride for Injection passed the consistency evaluation of generic drugs
Time of Update: 2021-04-27
On March 23, Hisun Pharmaceutical announced that the company's epirubicin hydrochloride for injection has passed the quality and efficacy consistency evaluation of generic drugs.
On May 5, 2019, the State Food and Drug Administration accepted the company's application for the consistency evaluation of epirubicin hydrochloride for injection.
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Koren Pharmaceuticals: Sodium fluconazole sodium chloride injections, etc. are evaluated consistently
Time of Update: 2021-03-12
at the same time, also issued a notice of approval, the company recently obtained the Approval Notice of the Chemical Drug "Fat Milk (10%)/Amino Acids (15)/Glucose (20%) Injection" approved by the State Drug Administration, which is evaluated by the quality and efficacy of generic drugs.
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Under the new edition of the pharmacopeia, the market demand for 33 agricultural residue detection items of Chinese medicine has skyrocketed
Time of Update: 2021-03-09
The pass rate of Chinese medicine drink tablets has been improved in Chinese herbal medicine, Chinese medicine tablets agricultural residue inspection pass rate, a number of third-party testing platform revealed the information figures are relatively close, according to their feedback, in recent times the detection situation, in fact, the relevant plant-based medicinal herbs and Chinese medicine tablets agricultural residues exceeded the standard phenomenon, is not our industry in the past worried about as serious.
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Pharmaceutical e-commerce for six consecutive years of high-speed growth funds counter-attack 15 stocks
Time of Update: 2021-02-06
Among them, the size of drugs reached 3 billion yuan, online pharmacy operations accounted for 27.3%, an increase of 57.9% over 2014.
