Mediaviews 媒体观点

Contact Us

 

 

  

Address: Beijing's xizhimen south street, xicheng district

 

The British garden 1 floor. Room 824

 

Zip code: 100035

 

Telephone: 010-58562339

 

Fax: 010-58562339

 

Email address: cngjzj@163.com

 

Web site (click on the url link directly left) :

 

http://www.cngjzj.com/

 

Blog (click on the url link directly left) :

http://blog.sina.com.Cn/CNGJZJ

 

To xizhimen south street, xicheng district building to the British garden route

L airport line 1

Take the airport shuttle from the airport, the dongzhimen station transfer to metro line 2 to xizhimen direction and get off at xizhimen station, from C outbound, go straight to the east 100 meters on the right side to xizhimen south street, north to walk to the t-junction namely to the British garden 1 floor downstairs.

L airport line 2

From the capital airport take airport bus to xidan, get off at no.22, take a taxi to xizhimen south street English garden 1 floor.

L bus subway near:

106 bus GuanYuan: 107 road, express way

Bus: xizhimen south road 387, 44 road, inner ring 800, 816 road, inner ring 820, 845 road

Che zhuang: subway line two

Xizhimen subway: metro line 2

Buses and attempts: 107 road, 118 road, 701 road

Buses and north zhuang: 209 road, 375 road, 392 road

 

Severely data fraud There are red line also should have the sun

2017年04月17日

复制链接 打印 大 中 小

<

 

Severely data fraud There are red line also should have the sun

The 2017-04-13

Source: health

- zhi-yong liu

 

On April 10th, the supreme people's court trial committee plenary meeting, review and principles through the supreme people's court, the supreme people's procuratorate about drugs, medical devices registration data fraud criminal case applicable law (SongShenGao) "the explanation of some issues. Crackdown on clinical reagent data fraud fire has been burning for nearly two years, the fraud conviction, knock again is undoubtedly a heavy hammer.

For drugs, medical devices registration data, especially during the clinical trial data fraud behavior, will seriously affect the drug quality and safety, and a challenge to the drug regulatory authority, the most intolerable, directly endanger people's health and life security, to the most stringent supervision and punishment, it is taken for granted. Related judicial interpretation is coming, send a clear message, data fraud not only is ethical issues, but also touch the red line of the law.

How severe the wind of clinical trial data are false, it is difficult to draw an authoritative answer, but "fraud data already exists, the specification the loss", in the industry has been around for a long time. In July 2015, the state food and drug supervision bureau inspection check storm began clinical trials data, released 1622 need to carry out the inspection verification of drug registration application varieties, in the end, the company actively withdrawn after their 1193 varieties, accounting for 83% of the total should be comprehensive. There was a mistake because of negligence or lack of ability to produce errors, and there must be active fraud of wrongdoing.

Supreme law released at the same time, the state drug supervision administration said publicly that for data of fraud behavior, is not included in the omission of serious adverse events may be associated with drug clinical trials, the omission of test scheme is the merger of the banned drugs, and so on and so forth. The news also drew a question of "whether regulation to backward". In fact, if strengthen the bat, the problems arised in the scientific experiment and test data fraud can be screened, the premise is to make sunshine transparent procedures and specifications to ensure, more introduction of peer review and supervision.

Only define the consequences of breaking the law, establish the supervision and management of sunshine specification and set up the serious legal consciousness and rigorous scientific attitude, can truly set in the field of pharmaceutical research and development should be the highest, promote the development of pharmaceutical products from made in China to created in China and progress.