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China's innovative drugs have entered the outbreak period of "going to sea", and another new drug license out
Time of Update: 2022-11-26
In recent years, with the rapid development of the domestic pharmaceutical innovation industry and the continuous enhancement of innovation strength, more and more Chinese innovative pharmaceutical c
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The ophthalmic treatment track has attracted attention, and a large number of enterprises have been taking new actions recently
Time of Update: 2022-11-26
js?cdnversion='+~(-new Date()/36e5)];With the aging of the population, the increase in the number of myopia, and the significant improvement of national health awareness, eye health management has become an important part of the "Healthy China 2030" strategy.
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BeiGene starts overtaking in a corner? National talks are coming, domestic PD-1 commercialization competition!
Time of Update: 2022-11-26
For the PD-1 monoclonal antibody "domestic tigers" of Innovent Biologics, Hengrui Pharmaceutical, BeiGene, and Junshi Biologics, which have long been included in medical insurance, the highlight of this year's medical insurance negotiations is to see the competition for new indications into medical insurance.
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MYVACET™ 9-45 Diacetylmonoglycerides registration number has been activated to "A" status!
Time of Update: 2022-11-26
Used in creams and ointments Diacetylmonoglycerides provide moisture protection At present, in addition to rabeprazole sodium enteric-coated tablets, colaveram hydrochloride tablets, sevelamam hydrochloride tablets, sodium valproate enteric-coated tablets, erythromycin enteric-coated tablets and other varieties have used diacetylmonoglycerides.
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Under the accelerated internationalization of local pharmaceutical companies, another domestic PD-1 product applied for going overseas!
Time of Update: 2022-11-26
Teripulimab is an anti-PD-1 monoclonal antibody drug independently developed by Junshi Biologics, and the submission of the marketing authorization application (MAA) to EMA means that after China and the United States, the global commercialization of teripulimab has begun to expand to Europe.
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Do not "fill in the blanks" for the decline in the proportion of drugs, and change the price of medical services to the same frequency as residents' income
Time of Update: 2022-11-26
criteriaof drugs Compared with the two programs, the increase in income generated by social and economic development is undoubtedly the resource space for medical service price reform.
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Under the favorable policy, domestic pharmaceutical companies began to focus on the research and development of children's anti-tumor drugs
Time of Update: 2022-11-26
js?cdnversion='+~(-new Date()/36e5)];Recently, CDE issued a notice to publicly solicit opinions on the "Technical Guidelines for Clinical R&D of Children's Antineoplastic Drugs", which covers four major chapters, including background, overall considerations for clinical R&D of pediatric antineoplastic drugs, clinical R&D paths for pediatric antineoplastic drugs, and issues requiring special attention, and the time limit for soliciting comments is 1 month from the date of issuance.
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CDE issued the notice of "Suspension of Review Timing and Restoration of Management Practices in the Process of Drug Evaluation by the State Medical Products Administration (Trial)"
Time of Update: 2022-11-26
Notice of the Center for Drug Review of the State Food and Drug Administration on the issuance of the "Management Practice for Suspension and Restoration of Review Timing in the Process of Drug Evalu
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When benefit-risk assessment becomes the focus, a new round of supply-side reform of innovative drugs begins
Time of Update: 2022-11-26
According to the Draft Opinion, the marketing application of innovative drugs: the benefits of drugs – risk assessment is a key process in regulatory decision-making, which ultimately determines whether it is approved.
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How to view inter-provincial tourism operation activities is no longer linked with risk areas to implement linkage management
Time of Update: 2022-11-26
On November 15, the Ministry of Culture and Tourism issued a notice on further optimizing the prevention and control measures of the new crown pneumonia epidemic, scientifically and accurately doing a good job in the prevention and control of the cultural and tourism industry, proposing that cross-provincial tourism business activities will no longer implement linkage management with risk areas, and increase the "one-size-fits-all" and layer-by-layer rectification of problems.
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National Health Commission: The state has not adjusted the diagnostic criteria for adult hypertension
Time of Update: 2022-11-26
standards Regarding the diagnostic criteria for hypertension, in 2005, 2010 and 2017, the national health administrative department issued publicity and education points, prevention and treatment guidelines, clinical pathways, etc.
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The State Food and Drug Administration held a work conference on promoting foreign trade and foreign investment in medicine
Time of Update: 2022-11-26
On November 15, 2022, in order to deeply implement the decision-making and deployment of the Party Central Committee and the State Council, and focus on the new mission and new requirements proposed in the report, the State Food and Drug Administration held a work conference on promoting foreign trade and foreign investment, studied and deployed measures to further strengthen the services of foreign-funded pharmaceutical enterprises, and do a good job in the service guarantee of key foreign-funded projects.
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Latest! EMA regulatory strategy adjustment for pharmaceutical nitrosamine impurities
Time of Update: 2022-11-26
Question 10: Upper limit of nitrosamine impurities in pharmaceutical products Two new nitrosamine compounds, 4-(methylnitrosoamino)-1-(3-pyridyl)-1-butanone (NKK), and N-nitrosoyl, are added to the document table, and the corresponding ADI (Acceptable Daily Intake) is specified Allowable daily intake) The limit is 100 ng/day.
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BeiGene starts overtaking in a corner? National talks are coming, domestic PD-1 commercialization competition!
Time of Update: 2022-11-26
For the PD-1 monoclonal antibody "domestic tigers" of Innovent Biologics, Hengrui Pharmaceutical, BeiGene, and Junshi Biologics, which have long been included in medical insurance, the highlight of this year's medical insurance negotiations is to see the competition for new indications into medical insurance.
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Domestic new drugs "Jinbao" accelerated, and 14 varieties such as Hengrui and Rongchang became the focus
Time of Update: 2022-11-26
In 2022, 25 rare disease drugs and children's drugs were shortlisted A few days ago, the National Health Insurance Administration officially announced that the expert review process in the adjustment of the national medical insurance catalogue in 2022 has ended, and it will soon enter the negotiation and bidding process.
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Under the trend of innovation, Chinese medicine companies are more and more willing to engage in research and development!
Time of Update: 2022-11-26
From the perspective of some large traditional Chinese medicine enterprises, R&D investment is relatively high, with 13 R&D investment exceeding 100 million yuan, including Baiyunshan, Tasly and Yiling Pharmaceutical.
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2022 Video Conference Autumn Exhibition, these three [Cloud Interview] live broadcasts must not be missed!
Time of Update: 2022-11-26
to better understand corporate brands, products, technologies and purchase good instrumentation products, this online exhibition will last until November 21 。 Click on the picture to watch the opening ceremony Online exhibition hall, cloud interview, summit forum, live selection, procurement hall.
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Announcement The General Department of the State Food and Drug Administration publicly solicits opinions on the "Announcement on the Implementation of Electronic Declaration of Drug Registration Applications (Draft for Comments)" and other documents
Time of Update: 2022-11-26
On the evening of November 4, the General Department of the State Medical Products Administration publicly solicited opinions on the "Announcement on the Implementation of Electronic Declaration of Drug Registration Applications (Draft for Comments)", which mentioned that from December 1, 2022, the drug registration applications reviewed and approved by the NMPA and the supplementary materials in the review process will be adjusted to be submitted in electronic form.
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$2.8 billion in large varieties to meet the fierce enemy, Huahai, Dongguang Medicine... 63 ANDAs were acquired
Time of Update: 2022-11-26
com From the perspective of the number of ANDA approvals in recent years, it reached the highest level in 2017, and the policy of "going overseas and reporting to China" has increased the speed of approval of relevant generic drugs in China, which will help domestic pharmaceutical companies quickly seize the market.
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The new version of the Administrative Measures for Drug Recall came into force on November 1
Time of Update: 2022-11-26
On October 26, the State Food and Drug Administration issued a newly revised Administrative Measures for Drug Recall (hereinafter referred to as the "Measures"), which came into force on November 1.
