男友太凶猛1v1高h,大地资源在线资源免费观看 ,人妻少妇精品视频二区,极度sm残忍bdsm变态

USEUROPEAFRICAASIA 中文雙語Fran?ais
China
Home / China / National affairs

Guideline speeds access to drugs

By Wang Xiaodong | China Daily | Updated: 2017-10-10 07:31

Drugs developed in other countries are expected to be available for use on the Chinese mainland more quickly under a new guideline released by the central government.

Authorities in China will now accept data collected from clinical trials conducted outside the mainland for applications to register drugs and medical equipment, according to the guideline on reforming approval procedures, which was released by the State Council on Sunday.

The data must be collected from clinical trials conducted at more than one center and must meet Chinese regulations for registration of drugs and medical equipment, the guideline said.

"The purpose of the measure is to reduce the time needed for approval of drugs from overseas," Wu Zhen, vice-minister of the China Food and Drug Administration, said on Monday.

China's current drug evaluation and approval system needs improving to expedite the use of new drugs in China, Wu said.

Under current regulations, food and drug authorities cannot accept clinical trial data collected from overseas, and new drugs being developed overseas should finish their first phase of clinical trials overseas before developers can apply to start clinical trials on the mainland, he said.

Guideline speeds access to drugs

This has delayed the availability of some major drugs on the Chinese market, he said.

Of 433 drugs approved for sale in developed countries between 2001 and last year, only 30 percent are available on the Chinese mainland.

Over the past 10 years, patients on the mainland have had to wait five to seven years longer for some major new drugs than patients in Europe and the United States, he said.

"This has caused an increasing number of people to buy drugs through the internet and from overseas, which has many potential risks," he said.

"Recognizing data collected from overseas can reduce unnecessary trials, which reduces the cost of drug research and development and improves Chinese patients' access to drugs," said Wang Lifeng, chief of product registration for drugs and cosmetics at the CFDA.

The CFDA will make more detailed regulations to better carry out the guideline, he said.

Meanwhile, the administration will intensify its supervision and inspection of clinical trials conducted overseas, and send inspectors to clinical trial centers overseas for site inspection to ensure that the data collected are accurate, Wang said.

The guideline also bans medical representatives from selling drugs and will hold them accountable if they have done so.

Editor's picks
Copyright 1995 - . All rights reserved. The content (including but not limited to text, photo, multimedia information, etc) published in this site belongs to China Daily Information Co (CDIC). Without written authorization from CDIC, such content shall not be republished or used in any form. Note: Browsers with 1024*768 or higher resolution are suggested for this site.
License for publishing multimedia online 0108263

Registration Number: 130349
FOLLOW US
 
主站蜘蛛池模板: 吉安市| 合水县| 仁布县| 洛川县| 岚皋县| 时尚| 同德县| 蚌埠市| 安顺市| 石嘴山市| 博罗县| 桐城市| 博野县| 夏河县| 江口县| 信宜市| 云林县| 晋城| 漠河县| 高青县| 治县。| 梧州市| 高雄市| 巴里| 绍兴县| 西峡县| 防城港市| 苗栗县| 郴州市| 巴彦淖尔市| 阳新县| 五家渠市| 施秉县| 宝清县| 酒泉市| 庆城县| 巨鹿县| 华阴市| 天台县| 吉首市| 略阳县|