SHANGHAI - China's State FDA recently published a new draft version of Good Manufacturing Practice guidelines for pharmaceuticals on its website for public comment.

SFDA used the GMP standards recommended by the World Health Organization as a reference to revise its current GMPs, SFDA said in a Sept. 23 notice.

The current GMP standards were enacted in 1999, and SFDA started to draft new GMP guidelines in September 2006 to improve drug quality and enhance compliance.

The new GMPs emphasize the connections between drug production, registration and postmarket monitoring, said an SFDA officer during an Aug. 27 seminar on improving the quality of drug manufacturing.

"The new GMPs will be the strictest GMPs ever in China. They are based on the U.S. cGMPs and comply with the global standards," Gao Huijun, director of Shanghai FDA's Institute for Food and Drug Safety, told PharmAsia News.

"For companies forming JVs with multinational pharmaceutical companies, the impact will be minor, since most of them have reached the cGMP requirements. However, for most of the small and mid-sized domestic pharmaceutical companies, the new GMP [guidelines] seem too strict," she noted.

The new guidelines require all drug companies to institute a quality attorney system, which assigns responsibility for drug manufacturing to a drug quality administrator.

SFDA issued the quality attorney system in April, which requires companies that produce blood products, vaccines, injectable drugs and controlled drugs such as narcotics and psychotropic drugs to implement the quality attorney system in 2009 (Also see "China Implements New Quality System To Strengthen Drug Safety; Puts Legal Onus On Drug Quality Attorneys" - Scrip, 22 April, 2009.).

Strict GMPs May Hamper Development Of Local Companies

Small and mid-size domestic drug companies in China will have to invest heavily to improve quality control systems and production facilities to comply with the GMP guidelines, according to Gao, who suggested lowering GMP requirements for small companies.

However, facing pressure from international markets, the government decided to implement the new GMP standards for all manufacturers, she said.

Serious adverse events and drug quality issues in recent years weighed heavily on the government to implement global standards to ensure drug quality in China, she noted.

During the last month, three deaths were reported that were caused by adverse drug reactions allegedly linked to the use of herbal injection Shuanghuanglian (Also see "Safety Of Traditional Chinese Medicine Injections Questioned Following Three Deaths" - Scrip, 1 October, 2009.).

Some of the new GMP standards have already been implemented in China, according to the director, and SFDA will release the final version after reviewing public comments.

"For example, the standards for sterile validation, which have been implemented now, already exceed the similar requirement in the U.S.," she noted.

"The strict requirements may obstruct the development of local companies, which cannot make huge investments to upgrade their current quality systems and production facilities to reach the new GMP [levels]. We need to find the balance between quality and cost," the director suggested.

Public comments on the guidelines will be accepted until Nov. 30.

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

China Releases Strictest Ever GMP Draft Guidelines; Laxer Standards Urged For Local Companies

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