Home / Government / Central Government News Tools: Save | Print | E-mail | Most Read
China Tightens Drug Approval Procedures
Adjust font size:

China's pharmaceutical watchdog will tighten the approval procedures for new medicines with the revised regulation on medicine registration taking effect on Oct. 1.

Wu Zhen, deputy-director of the State Food and Drug Administration (SFDA), made the remarks on Wednesday at the SFDA's first regular press conference.

Wu said the SFDA would take stricter measures to check drugs under approval, including intensifying examinations of production, spot testing samples, and re-examining drugs already on market.

The current regulation on medicine registration came into effect on May 1, 2005.

"Before its revision, the regulation allowed for lax monitoring and examination of production," Wu said.

"Application documents have been inadequate and there have even been serious forgery problems, so it's pretty hard to ensure the safety of drugs," Wu said.

"In the past, the functions of some approved drugs were found to vary from the original applications, which endangered public health," Wu said.

Research institutes, manufacturers and individuals who apply for registration of new drugs should provide comprehensive, reliable research documents to prove the safety, effectiveness and quality of the drug, and pledge the truth and accuracy of all information in the application materials.

Under the revised regulation, those who use false application documents will be fined or deprived of the right to file applications, and the government will blacklist those who break the rules.

"Once a medicine manufacturer enters the blacklist, its products will also be listed," he added.

"This way, medicine approval will be placed under public supervision and avoid misuse of power," Wu said

(Xinhua News Agency July 12, 2007)

Tools: Save | Print | E-mail | Most Read

Related Stories
Ex-Drug Head Executed
Parkinson's Drug to Be Withdrew from Market
China Tightens Controls on Blood-based Medicines
Local Gov'ts Asked to Co-op with Drug Watchdogs
Watchdog to Regularly Report Food, Drug Safety Info
Questions and Answers More
Q: Where Can You Take An HIV Test in Guangzhou City?
A: There are three state-designated HIV testing centers in Guangzhou: Guangdong Center for Disease Control and Prevention, Guangdong Entry-Exit Inspection and Quarantine Bureau, and Guangzhou Center for Disease Control and Prevention.
Useful Info
- Who's Who in China's Leadership
- State Structure
- China's Political System
- China's Legislative System
- China's Judicial System
- Mapping out 11th Five-Year Guidelines
Links
- Chinese Embassies
- International Department, Central Committee of CPC
- State Organs Work Committee of CPC
- United Front Work Department, Central Committee of CPC
SiteMap | About Us | RSS | Newsletter | Feedback
SEARCH THIS SITE
Copyright © China.org.cn. All Rights Reserved E-mail: webmaster@china.org.cn Tel: 86-10-88828000 京ICP证 040089号