Transparency is Goal for Chinese FDA
by Richard Daverman, PhD
ChinaBio Today
Changes Seek to End Corruption
In a high-profile move to burnish the image of its food and drug regulatory program, the State Food and Drug Administration of China will institute reforms in its approval process, beginning October 1 of this year.
Wu Zhen, deputy chief of the SFDA, told a news briefing that drugs would be approved by a specially appointed panel, rather than a single official. Also, drug companies and R&D institutes will be provided with means to find out what is happening with the drugs under review.
Previously, according to reports, drug companies had to find a source in the SFDA who would tell them the name of the official in charge of their prospective drug and where the drug was in the approval process.
The changes in procedure were put in place to increase transparency and decrease the amount of corruption that crept into the previous system.
Also, regional authorities will once again have the power to perform preliminary approval procedures. Under the most recent head of the SFDA, Zheng Xiaoyu, all approval work was centralized. Zheng Xiaoyu was executed earlier this week, after he was found to have taken bribes to approve fake drugs. One antibiotic that was approved under Zheng’s regime killed at least 10 people (see story).
Another new regulation stipulates that any company providing false information or doctored samples to the SFDA will be prevented from applying for approval of any drug for three years.
The SFDA will also conduct periodic unannounced spot checks on drug producers.
At the same time, in a related initiative, the General Administration of Quality Supervision, Inspection and Quarantine said on its website that the agency would begin tightening regulation of the almost 500,000 processors of food, prohibiting them from re-using food and raising the hygiene requirements in their operations. Unapproved additives or substances can not be added to food, they added.
Over the next two years, regulators want to cut the number of food processors, most of whom have fewer than 10 employees, in half.
RELATED READING:
- China Executes ex-SFDA Head
- China in Need of Good Crisis Counseling
- Beijing Bans Ten Illegally Advertised Drugs
ChinaBio Today is a regular contributor to BioHealth Investor
_______________
ChinaBio Today
Changes Seek to End Corruption
In a high-profile move to burnish the image of its food and drug regulatory program, the State Food and Drug Administration of China will institute reforms in its approval process, beginning October 1 of this year.
Wu Zhen, deputy chief of the SFDA, told a news briefing that drugs would be approved by a specially appointed panel, rather than a single official. Also, drug companies and R&D institutes will be provided with means to find out what is happening with the drugs under review.
Previously, according to reports, drug companies had to find a source in the SFDA who would tell them the name of the official in charge of their prospective drug and where the drug was in the approval process.
The changes in procedure were put in place to increase transparency and decrease the amount of corruption that crept into the previous system.
Also, regional authorities will once again have the power to perform preliminary approval procedures. Under the most recent head of the SFDA, Zheng Xiaoyu, all approval work was centralized. Zheng Xiaoyu was executed earlier this week, after he was found to have taken bribes to approve fake drugs. One antibiotic that was approved under Zheng’s regime killed at least 10 people (see story).
Another new regulation stipulates that any company providing false information or doctored samples to the SFDA will be prevented from applying for approval of any drug for three years.
The SFDA will also conduct periodic unannounced spot checks on drug producers.
At the same time, in a related initiative, the General Administration of Quality Supervision, Inspection and Quarantine said on its website that the agency would begin tightening regulation of the almost 500,000 processors of food, prohibiting them from re-using food and raising the hygiene requirements in their operations. Unapproved additives or substances can not be added to food, they added.
Over the next two years, regulators want to cut the number of food processors, most of whom have fewer than 10 employees, in half.
RELATED READING:
- China Executes ex-SFDA Head
- China in Need of Good Crisis Counseling
- Beijing Bans Ten Illegally Advertised Drugs
ChinaBio Today is a regular contributor to BioHealth Investor
_______________
posted by Nico at
4:59 PM
0 Comments:
Post a Comment
Subscribe to Post Comments [Atom]
<< Home