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The State Food and Drug Administration applies the ICH guidelines of "Q3C (R8): Impurities: Residual Solvents"
Time of Update: 2021-12-24
2. Relevant technical guidelines can be found on the website of the Center for Drug Evaluation of the State Drug Administration .
The Drug Evaluation Center of the National Medical Products Administration is responsible for the relevant technical guidance during the implementation of this announcement .
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The State Food and Drug Administration applies the ICH guidelines of "Q3C (R8): Impurities: Residual Solvents"
Time of Update: 2021-12-24
2. Relevant technical guidelines can be found on the website of the Center for Drug Evaluation of the State Drug Administration .
The Drug Evaluation Center of the National Medical Products Administration is responsible for the relevant technical guidance during the implementation of this announcement .
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Is the enthusiasm of pharmaceutical companies going public on the science and technology innovation board "heating up" or "cooling down"?
Time of Update: 2021-12-24
According to incomplete statistics, as of December 20, a total of 14 pharmaceutical companies have terminated their applications for listing on the Sci-tech Innovation Board in 2021 due to voluntarily withdrawing and failing the review.
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A large number of chain pharmacies have been cancelled!
Time of Update: 2021-12-24
According to data from the National Food and Drug Administration, as of the end of March 2021, the total number of pharmacies nationwide reached 561,000, of which 241,900 were monomer pharmacies and 319,100 were chain stores; as of the end of June 2021, there were a total of " There are 598,900 companies holding the "Pharmaceutical Business License" .
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The pace of internationalization of pharmaceutical machinery companies is also accelerating as local innovative pharmaceutical companies go abroad to speed up
Time of Update: 2021-12-24
. In fact, in the context of severe homogeneity of products in the domestic equipment market and increasingly fierce market competition, pharmaceutical machinery companies are also accelerating the development of overseas markets and formulating international strategies in order to seek new growth points .
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The State Food and Drug Administration canceled 210 drug registration certificates and 6 medical device registration certificates
Time of Update: 2021-12-24
The original text is as follows: Announcement of the State Food and Drug Administration on the cancellation of 210 drug registration certificates including chloramphenicol tablets (No.
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The price of this new AD drug will be reduced by 50% from January next year
Time of Update: 2021-12-24
It should be noted that, unlike the increasing number of patients, in the medical industry, the development of new drugs for Alzheimer’s disease is very Mount Everest, which is difficult to climb, has a very high risk and failure rate; this has also led to the fact that since the discovery of Alzheimer’s disease for more than 100 years, there are still few drugs used for clinical treatment in the world, and they are expensive.
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NMPA publicly solicits opinions on "Guiding Principles of Pharmacovigilance Inspection (Draft for Comment)"
Time of Update: 2021-12-24
On December 1, the Comprehensive Department of the State Food and Drug Administration issued an announcement stating that, in order to implement the Pharmaceutical Administration Law of the People’s Republic of China and the Vaccine Administration Law of the People’s Republic of The Bureau organized the drafting of the "Guiding Principles for Pharmacovigilance Inspection (Draft for Soliciting Comments)" (see Annex 1), which is now open to the public for comments .
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Zhejiang Pharmaceutical ARX305 obtains notification of acceptance of drug clinical trial application
Time of Update: 2021-12-24
, received a statement issued by the National Medical Products Administration regarding the company’s research drug for injection with recombinant humanized anti-CD70 monoclonal antibody-AS269.
The main clinical indications for the development of these drugs are advanced Kidney cancer and lymphoma .
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It's about drug registration!
Time of Update: 2021-12-24
CDE clarified that registration applications accepted from the date of implementation of the "Start-up Procedure" shall be implemented in accordance with the relevant requirements of this procedure .
Registration applications accepted before the implementation date shall still be implemented in accordance with the original relevant regulations .
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A letter from the Provincial Food and Drug Administration to the holders of drug marketing licenses across the province!
Time of Update: 2021-12-24
" The Shandong Adverse Drug Reaction Monitoring Center reminds holders of each drug's marketing authorization to establish and continuously improve the pharmacovigilance system, carry out pharmacovigilance activities steadily, and ensure that pharmacovigilance activities continue to meet the requirements of relevant laws and regulations .
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The price of 4 billion large varieties has been reduced by 97%, and foreign companies are actively "on the top"!
Time of Update: 2021-12-24
This can be seen from the price reduction of dexmedetomidine hydrochloride injection in Hubei and Shandong for renewed bids .
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Notice of the Drug Evaluation Center on matters related to communication services
Time of Update: 2021-12-24
3. For real-time consultation on registration acceptance and review services, our center will adjust the public day consultation every Wednesday to telephone consultation according to the requirements of epidemic prevention and control.
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With regard to excipients and pharmaceutical packaging materials, the "Technical Requirements for Pharmaceutical Research of Chemical Inhalation Liquid Preparations" requires that...
Time of Update: 2021-12-24
On November 26, the Center for Drug Evaluation of the National Food and Drug Administration issued the "Technical Requirements for Pharmaceutical Research on Inhaled Liquid Preparations of Chemical Drugs", including technical requirements for prescription technology, technical requirements for quality control of original and auxiliary packages, technical requirements for quality research and control, and stability studies And other parts put forward specific requirements for excipients and pharmaceutical packaging materials .
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The antibacterial class 1 new drug market broke out, and a pharmaceutical company soared by more than 2000%
Time of Update: 2021-12-24
. The data shows that the sales of Class 1 new drugs in the field of systemic antibacterial drugs that have successfully entered the medical insurance catalogue are also moving .
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Forecast for the seventh batch of centralized procurement of antibacterial drugs!
Time of Update: 2021-12-24
Meinenet data shows that under the further impact of centralized procurement and the epidemic, the terminal systemic antibacterial drugs used in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) will drop by 26.
Reference monitoring scope of alternative drugs for centralized collection of systemic antibacterial drugs26 billion market!
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The CRO industry has entered an explosive period, and pharmaceutical equipment companies have also seized the opportunity to actively deploy
Time of Update: 2021-12-24
The company's development of a characteristic CRO business that combines pharmaceutical equipment and technology can further improve the technical level of the business, and at the same time, it can establish differentiated business advantages, establish unique market competitiveness, and build an industrial ecology .
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News: Sunward Pharmaceuticals Invests in Hefei R&D Center
Time of Update: 2021-12-24
, a wholly-owned subsidiary, and the Investment Promotion Bureau of Hefei High-tech Industrial Development Zone intend to sign the "Anhui Sunward Pharmaceutical Auxiliary Hefei R&D Center and Production Base Project Investment Agreement" recently.
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Sanofi Metadragon receives new indication in China for the treatment of sinus rhythm with a history of atrial fibrillation
Time of Update: 2021-12-24
According to the press release, Maidarone is the only antiarrhythmic drug that has been proven to significantly reduce the risk of hospitalization or all-cause death in patients with atrial fibrillation, providing a long-term effective and safer treatment option for patients with atrial fibrillation .
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Jimincred’s first category 3 generic inhalation application was accepted by CDE
Time of Update: 2021-12-24
Institute of Innovative Technology Drugs independently developed the first three types of generic inhalation preparations-Levalbuterol Hydrochloride Nebulized Inhalation Solution, which has been approved by the National Drug Administration The Center for Drug Evaluation (CDE) of the Bureau accepted .
