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Industry News

INTERPHEX China 12-14 May 2009 Xi'an, China

Promulgator: :admin   Send date: :2009-12-29 Visitor: :

China 's 2009 Regulatory Changes Will Affect Makers of Drugs, APIs and Devices

An array of regulatory and legal changes covering pharmaceuticals and medical devices in China is likely to be launched or broadened this year, including new GMP guidelines, as the country aims to upgrade supervision of the entire health care sector, according to a leading Chinese lawyer in the area of life sciences-related issues and legislation. fff

New or amended regulations will impose more stringent requirements on makers of medical devices, of medicines and of active pharmaceutical ingredients, said Yang Chen, who heads the life sciences team at the Beijing office of the law firm Sidley Austin.

For international makers of medical devices, Yang said, "The SFDA [in 2008] for the first time imposed joint liability on the Chinese agents of foreign device manufacturers in terms of adverse event reporting, product recalls and after-sales services."

This year, she added, China 's State FDA is likely to introduce new good manufacturing practices guidelines for all device makers with operations in the country.

"The State Food and Drug Administration is in the process of training GMP auditors for drug producers," said Yang, and more stringent GMP standards will ultimately cover drugs and APIs.

Following a December 2007 agreement on strengthened cooperation between the U.S. Department of Health and Human Services and the SFDA, and the establishment of three U.S. FDA satellite outposts in China , SFDA agents are likely to accompany their FDA counterparts during GMP inspections in China .

Likewise, aimed at stepping up supervision of the health care sector is an SFDA plan to broadly extend a pilot program that now requires domestic makers of blood products, vaccines and certain high-risk drugs to carry electronic tags with essential identifying information.

FDA launched the pilot program and its electronic tracking network in the second half of 2008 and aims to eventually require that all pharmaceuticals and biologics sold in China are marked with these barcode tags.

The tags must contain identifiers including the manufacturer's name and location, the product name, the date of its production and expiration, proper dosage, and regulatory approval data.

The SFDA has said that starting from 2009, all drugs marketed in China , including imported pharmaceuticals, will be required to be electronically tagged," Yang said. "But it is still uncertain if the SFDA will actually reach this goal by the end of the year," she added.

The new tracking system is being created to help China 's drug regulators apply state-of-the-art technology in the monitoring of pharmaceuticals, and will lay the groundwork for a rapid response to any adverse events triggered by drugs or devices. The electronic network and tags are also aimed at cracking down on poorly made or counterfeit products.

China's government pledged to prosecute makers of counterfeit drugs in its December 2007 agreement with the U.S., but so far has not issued new rules that would aid in that drive.

Meanwhile, SFDA's Center for Drug Reevaluation has recently requested filing of Phase IV trial protocols, or postmarketing trials, on a voluntary basis. It remains to be seen if this filing request is a prelude to SFDA requiring mandatory Phase IV trials on a wider basis.

Scanning the regulatory horizon, Yang said that China 's SFDA and Ministry of Health are likely to finish formulating a new essential drugs list as part of the next phase of sweeping health care reforms planned for the next decade.

"Essential drugs should be generally available to the public at a reasonable price," said Yang, who added that the government is working out pricing guidelines for medicines slated for inclusion on this list.

In the past, China 's National Development and Reform Commission has periodically singled out certain drugs to be subject to a government-mandated price cut.

In the future, the government could opt to combine its state price targets for select medicines with the power to force drug companies to license their products under the amended patent law.

"There could be an interplay," said Yang, "between the essential drugs list and the compulsory licensing provision of the amended patent law."

- Kevin Holden

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