SHANGHAI - China's State FDA launched a new quality system April 10 that requires companies to assign responsibility for drug manufacturing to a drug quality administrator. The move builds accountability into drug manufacturers' systems.

According to an SFDA notice, the quality attorney system requires each company to designate one individual authorized to validate, manage and supervise drug production and conduct internal audits.

Under the notice, four kinds of companies must implement the quality attorney system in 2009: those which produce blood products, vaccines, injectable drugs and controlled drugs such as narcotics and psychotropic drugs.

A pilot system was implemented in some provinces in 2007. Guangdong, a southern province, which has 542 pharmaceutical companies accounting for roughly one-eighth of the total in China, is the first province to launch the system and has covered all drug makers in the province since July 2008 (Also see "Chinese Province Implements Pilot Quality System To Strengthen Drug Safety" - Scrip, 30 July, 2007.).

"The attorney system is just like the quality control regulations in good manufacturing practices used in developed countries," said Wu Zhen, deputy director of SFDA, during the initiation ceremony of the pilot program in Guangdong. "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.

According to the latest notice, a quality control attorney must have a bachelor's degree in pharmacy or a related specialized field and must be familiar with drug quality standards, manufacturing processes, GMPs and related laws and regulations. Attorneys also must have five years of experience in drug production quality management.

"The criteria for a quality attorney are not high," Stephen Wong, a lawyer at Shanghai-based Lebang law firm, told PharmAsia News.

"According to the definition from the notice, the attorney should be an employee not involved in the manufacturing process. One of the quality attorney's duties is to supervise the quality control department, so if the company designates staff in the quality management department, how to execute the supervision authority [to self-supervise] may be a key point for the attorney." Wong added.

"The new system changes the responsibility in the company. If a quality issue happens, the quality attorney will take the main responsibility, so how to balance the power between the attorney and the other management in the company is another key point here," Wong said.

The attorney can only be authorized after he passes a training program provided by local FDAs, and he or she is required to attend follow-up training programs. Local FDAs will add quality attorney system inspections to the regular inspections of drug makers, according to SFDA.

Sun Liping, a lawyer at Guangdong-based United Intellectus law firm, suggested in an early interview with PharmAsia News that enlisting a third party to take part in the quality attorney system would be more effective and would help maintain the independence of the attorney.

- Dai Jialing (j.dai@elsevier.com)

China Implements New Quality System To Strengthen Drug Safety; Puts Legal Onus On Drug Quality Attorneys

More from Archive

More from Scrip