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Hispec innovative drugs to be included in the priority review
Time of Update: 2020-04-03
On January 19, 2020, SDA accepted the application for "general anesthesia induction" indication new drug (special approval procedure), and on January 22, 2020, it undertook the drug registration application submitted by the company.
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Jingxin Pharmaceutical Co., Ltd. and xinlitai entered the three in one review on the same day
Time of Update: 2020-04-03
According to the new drug review process, after the completion of the three in one review, only the drug review center forms a report, submits CFDA for signature and other procedures.
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Hengrui paclitaxel and Lizhu eprazole accelerate the review
Time of Update: 2020-04-03
On Friday (October 28), it released the announcement of drug registration application to be included in the priority review procedure, with 29 acceptance numbers getting the opportunity of priority review.
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Changshan pharmaceutical heavy weight chemical "daparin sodium injection" review process returned to normal
Time of Update: 2020-04-03
According to the website of the State Food and Drug Administration (CFDA) on March 31, the review status of the blockbuster drug "heparin sodium" bulk drug and injection
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Reading experience, extensive reading is difficult to write good book reviews
Time of Update: 2020-04-03
But in the first reading of Don Quixote, it is very difficult to write book reviews.
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HER2 specific TKI of Seattle genetics is qualified for priority review
Time of Update: 2020-02-14
Today, Seattle genetics announced that the FDA has accepted its new drug application (NDA) for the treatment of unresectable locally advanced or metastatic HER2 positive breast cancer with trastuzumab and capecitabine.
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Welfare release! Issuance of guidelines for real world evidence supporting drug development and review
Time of Update: 2020-01-08
In order to further guide and standardize the use of real world evidence in supporting drug R & D and review, and to ensure the quality and efficiency of drug R & D, the State Drug
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Paclitaxel injection of Huiyu pharmaceutical is to be included in the priority review
Time of Update: 2019-12-26
At present, Paclitaxel injection has not been evaluated by the enterprise, and Huiyu pharmaceutical has applied for production of new 4 categories of chemical drugs.
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The speed of review and approval has been increasing year by year, and the number of innovative drugs in China will continue to rise
Time of Update: 2019-12-25
The "life saving drugs" priority review and approval policy has been continuously improved and implemented, and the whole regulatory process has been greatly accelerated, which makes the number of innovative drugs listed in China continue to rise.
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In 2019, the reform of drug review and approval continued to deepen. What are the achievements
Time of Update: 2019-10-18
It can be seen that with the improvement of China's innovation and R & D environment, the acceleration of examination and approval, and the growing pharmaceutical market, foreign pharmaceutical enterprises are deeply attracted.
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Environmental protection epichlorohydrin process package of Baling Petrochemical Co., Ltd. passed the review
Time of Update: 2019-09-06
The whole process was completed and a 50000 ton / year process package was developed.
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The revised draft of drug administration law will be reviewed again next week
Time of Update: 2019-08-16
At the chairman's meeting, Yang Zhenwu, Secretary General of the Standing Committee of the National People's Congress, made a report on the draft agenda and schedule of the twelfth session of the Standing Committee.
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[just] CDE: Notice on matters related to chemical generic reference preparation under review
Time of Update: 2019-08-05
Drug evaluation center of SDA August 5, 2019
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New requirements for related review and approval of the original auxiliary package, implemented on August 15
Time of Update: 2019-07-17
In order to implement the opinions of the general office of the CPC Central Committee and the general office of the State Council on deepening the reform of the review and approval
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2018 annual drug review report is released! Pay close attention to these key points
Time of Update: 2019-07-05
[trends of pharmaceutical Station industry] how about drug evaluation in China in 2018? On July 2, the drug review center of the State Food and Drug Administration issued the 2018
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The first review of Chinese Biopharmaceuticals
Time of Update: 2019-04-26
A few days ago, China biopharmaceutical announced that the new expectorant fludostam tablets (trade name: Zhongchang) of its subsidiary Jiangsu Zhengda Fenghai Pharmaceutical Co
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Newest! 2018 FDA drug review report
Time of Update: 2018-12-14
Recently, CDER under FDA released the drug review report for 2018 (as of November 30).
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Inventory from January to October 2018: review and approval data of domestic drugs
Time of Update: 2018-11-23
Among them, many new drugs have set a number of "first" records on the market, and these achievements are actually changes in drug review and approval in China.
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Review of China's biomedical industry policies in the third quarter of 2018
Time of Update: 2018-10-23
On August 8, Guangdong health and Family Planning Commission issued the notice on Strengthening Drug Administration and drug control in medical institutions to promote the high-quality development of pharmaceutical care (Draft for comments).
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Of the 1397 varieties reviewed, Pfizer, Novartis, GSK, China biopharmaceutical, etc. who declared the most
Time of Update: 2018-07-05
CDE mid-2018 inventory: 1770 variety applications were undertaken and 1397 varieties were reviewed; Pfizer's 8 new application varieties ranked first in the application, followed
