Chinese Province Implements Pilot Quality System To Strengthen Drug Safety
SHANGHAI – In the latest effort to strengthen drug safety measures in China, Guangdong province has taken a page out of the international quality systems playbook, launching a pilot system July 20 that assigns responsibility for drug manufacturing quality to a designated company official.
Guangdong, the first Chinese province to run this system, has 542 pharmaceutical companies, accounting for roughly one-eighth of the total in China. The new quality attorney pilot system covers only drugs manufactured in Guangdong, and not drugs imported into the province.
“The latest measure will strengthen drug safety supervision by further defining responsibilities and raising the level of pharmaceutical safety and quality management,” Guangdong FDA Director General Chen Yuansheng said July 12, during the initiation ceremony for the pilot system.
“Guangdong, as the first pilot province, will play a crucial role in the nationwide rollout of the pharmaceutical production quality attorney pilot system and the effectiveness of its implementation will affect the nationwide system,” State Food and Drug Administration Deputy Director Wu Zhen announced during the ceremony.
This action follows other recent moves by the government to strengthen drug safety, including a new drug registration regulation that will go into effect Oct. 1 (PharmAsia News, July 23, 2007).
“The attorney system is just like the quality control regulations in good manufacturing practices used in developed countries,” said Wu. “The implementation of GMP is an international norm in the drug production quality control system, which though effective, needs improvement.”
“This measure is a way to improve the companies’ internal management and create a new system to enhance drug safety supervision,” he added.
An initial batch of 30 companies, chosen because they are producing high-risk drugs or have a good quality control system, are now undergoing training. A second batch of companies will be announced in January, and by July 2008 the system is set to cover all drug manufacturers in Guangdong province.
Other provinces are also taking action; Hubei province announced that it will launch the quality attorney pilot system before year-end.
The quality attorney system requires each company to designate one individual authorized to sign off on – and take responsibility for – all aspects of quality control. Attorneys may have their qualifications revoked if a serious quality issue is uncovered or if the company violates GMP requirements. Attorneys also may be subject to prosecution, and companies could be punished by the provincial FDA.
Under the Guangdong pilot system, a quality attorney must be a licensed pharmacist familiar with GMPs and related laws and regulations. Attorneys also must have five years of experience in drug production quality management.
But according to Sun Liping, a lawyer at Guangdong-based United Intellectus law firm, “It is difficult for the FDA to identify whether the attorney has met all the requirements, since the attorney is nominated and authorized by the company.”
Currently, 102 attorneys and directors of the drug safety monitoring branch department of the municipal FDAs have started training with the provincial FDAs.
“Our company ran a similar system in 1994, which was based on the GMP system for biological products issued by the World Health Organization,” a quality manager at Guangdong-based Wellen Biological Pharmaceutical Co., told PharmAsia News.
“The difference between that system and the attorney system is that the latter is more specific in the details,” he said, wishing to remain anonymous. “And in my company, the attorney will be our general manager, our quality manager, and be in charge of our civil and legal obligations.”
However, not everyone is entirely pleased with the pilot system.
“Since the attorney is an employee nominated by the company, it seems hard to keep the attorney independent, to execute his authority and make an objective judgment,” Sun said in an interview with PharmAsia News. “The measure is just a trial one. It still needs revision and as a matter of fact, the FDA is giving some administrative responsibility of supervision to the pharmaceutical companies.”
“However, if some third party could take part in the attorney system, it would be much more effective,” he said.
– Dai Jialing
© FDC Reports 2007 - All Rights Reserved
