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Notice of the general office of the State Health Commission on strengthening the management of diagnosis and treatment of chronic wounds (ulcers) on the body surface

Notice of the general office of the State Health Commission on strengthening the management of diagnosis and treatment of chronic wounds (ulcers) on the body surface

In order to strengthen the management of diagnosis and treatment of chronic refractory wounds (ulcers), improve the level of diagnosis and treatment, ensure the safety of patients and the quality of diagnosis and treatment, and safeguard the health rights and interests of the people, the general office of the National Health Commission issued the notice on strengthening the management of diagnosis and treatment of chronic refractory wounds (ulcers) on December 2, 2019.

05

2019

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12

The announcement of CFDA will effect a large collection of pharmaceutical companies

The announcement of CFDA will effect a large collection of pharmaceutical companies

On April 28th, CFDA released “an announcement on cancelling to provide 36 items of documents (NO.34 file of 2019)”that will effect a large collection of pharmaceutical companies.

29

2019

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04

Can we win the battle with “Super Bacteria”?

Can we win the battle with “Super Bacteria”?

Lately, an article on internet named “A middle-aged man haunted by flu in Beijing” caused tremendous response, the author’s suffering is sympathetic and thought-provoking. Apart from problems in modern medical system, this article also reflects a sever challenge in biological and medical science. The patient infected with an unknown virus and antibiotics Super Bacteria, whose condition worsened and died within a month, whereas the modern medical science has nothing to do with it. In fact, clinical cases infected with Super Bacteria appeared occasionally in recent years, and its frequency has been arising and abuse of antibiotics has been forming a great threat to public health security in decades of years. Since appearance of medical science, human have been fighting with bacteria for thousands of years. Fleming found penicillin in 1928 that is a biological weapon comes from antinomyces and fungus, and it once made human had upper hand in the battle, however, along with antibiotics appearance and overgrowth of varied bacterial flora, human is losing is dominant position in the battle. It is reported that if this is situation develops, 30,000,000 people will die of drug-resistant bacteria until 2050[1].

02

2018

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03

CFDA announced drug clinical trial agency with qualification (No. 57, 2017)

CFDA announced drug clinical trial agency with qualification (No. 57, 2017)

On May 16th, 2017, CFDA announced drug clinical trial agency with qualification (No.7), No. 57, 2017). It is pointed out in the announcement that according to Drug Control Law of P.R.C. and Measures of Drug Clinical Trial Agency Qualification Accreditation (on trial), after data review and on-site inspection, including International Hospital of Peking University, 149 medical agencies were recognized as drug clinical trial agencies, and granted them with “ Certificate of Drug Clinical Trial Agency”.

23

2017

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05

Ministry of Science and Technology print and distribute biotechnology innovative plan of “the 13th five year plan”

Ministry of Science and Technology print and distribute biotechnology innovative plan of “the 13th five year plan”

On May 10th, 2017, Ministry of Science and Technology published news on official website that for accelerating biotechnology and its industrial development, the biotechnology innovative plan of “the 13th five year plan” is formulated. (Hereinafter referred to as “the Plan”)

19

2017

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05

Reducing the backlog of drug registration radically is good for some enterprises

Reducing the backlog of drug registration radically is good for some enterprises

At night of July 31st, 2015, CFDA released an “Announcement about soliciting opinions on policies of reducing the backlog of drug application registration” (No.140, 2015) (hereinafter referred to as “Soliciting opinions” After CFDA released an “Announcement about self-checking drug clinical trial data” on July, 22nd, they take a second movement on revolution of drug registration. According to “Soliciting opinions”, on the one hand CFDA will actively support R & D and application of innovative drug, children’s drug, clinical urgent need and shorted drug, and rob imitation drugs, on the other hand they will no longer tolerate on drugs with problems of safety, effectiveness, and quality. It will not work to change preparation or acid root. The drug with clinical value or urgent needed is in priority. Fight for resource with high quality will be more violent.

28

2015

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08

Drug appraisal enters into an era of four colors of light, and which color is yours?

Drug appraisal enters into an era of four colors of light, and which color is yours?

The Drug Appraisal, Examine and Approve Institutional Reform Working Conferenced was hold in Shanghai. Bi Jingquan, the Director of CFDA, and Wu Zhen, the Deputy Director of CFDS were present at the conference. The conference is about polices of dealing with appraisal backlog, classify “global new” innovative drugs into district with “no color light”, classify drug that is clinical needed or good for industrial transformation into district with “green light”, classify repeated declared imitation drug into district with “yellow light”, classify restricted appraisal drug into district with “red light”, and release catalogue of restricted appraisal drug in time.

27

2015

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08

WTO release the first Global Antibiotics Resistant Report

WTO release the first Global Antibiotics Resistant Report

On May 5th, 2014, a new report released by WTO makes us examine global antibiotics resistant for the first time, which indicates that the severe threat of antibiotics resistant is no longer a forecast for the future, it is happening all around the world, and it has the potential to affect everyone no matter what age or nationality. When mutation happens to bacteria, antibiotic is no longer effective to people who need it for treatment, that is called antibiotic resistant, which has formed a great threat to public health.

06

2014

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05

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