BEIJING - In an effort to fast-forward the globalization of China's drug laws and utlimately boost its exports of pharmaceuticals, the Shanghai FDA is partnering with a U.S.-based law firm to co-host its first international forum on drug safety and regulatory change.

The large regional FDA has set up a new think tank, the Shanghai Institute for Food & Drug Safety, that is inviting government leaders, judges, heads of corporations, and scholars from around the world to compare different drug supervision regimes as China prepares to update its own system.

The just-launched government think tank is being granted a great degree of latitude to cooperate with regulators and lawmakers worldwide, and to review U.S., European Union and Japanese laws on pharmaceuticals and medical devices for consideration in the amendment of Chinese rules, said Scott Bass, who heads the global life sciences team at the international law firm Sidley Austin.

Sidley, which will cohost the Oct. 29-30 forum, recently signed an agreement with the Shanghai institute to work together to "conduct a broad study of and use as reference the legislation, regulatory regimes, and judicial practices of major countries from the EU and the United States." (Also see "Shanghai FDA Signs Agreement With U.S. Law Firm To Foster International Cooperation on Drug Regulation" - Scrip, 7 August, 2008.).

Through the upcoming forum and other expanding exchanges, Chinese healthcare policymakers aim to examine and pinpoint "the best parts of the U.S. and EU law systems," said Bass, who is based in Sidley's Washington D.C. office. This worldwide review of drug regulations, he added, "could be a catalyst for innovative changes initiated in China."

As Chinese drug manufacturers prepare to expand exports and multinationals set up manufacturing and clinical research organizations in China, the country "needs regulations that provide an assurance of a very high level of safety," he explained.

In the first in a series of annual forums, the new Shanghai institute will host representatives from China's State FDA and National Center for Adverse Drug Reaction Monitoring, the European Agency for the Evaluation of Medicinal Products, and the U.S. Department of Health & Human Services.

"We will use this forum and international interactions to compare drug regulations from all over the world," said a high-level official at the Shanghai FDA. SFDA will then consider this input as it prepares to revise China's own regulations, he added.

Also set to speak at the global gathering are a judge from a U.S. District Court, executives from Johnson & Johnson and Sanofi-Aventis, and an array of life science lawyers including Bass.

"China wants international input on creating a state-of-the-art regulatory system," Bass told PharmAsia News.

During this first international gathering, Chinese drug regulators will focus on the world's highest levels of pharmacovigilance, on rapid responses to adverse drug reactions and compensation for ADR victims, and on Phase IV monitoring of drugs.

"A lot of the international pharmaceutical companies have set up their headquarters here, and the Shanghai FDA has wide experience in cooperating with foreign counterparts including U.S. FDA officials," the Shanghai FDA leader explained.

This first forum, he added, "will provide guidance to the government on how to expand cooperation with other countries."

"The Shanghai FDA has many experts who have graduated from American universities, and has had good exchanges with the American FDA," he told PharmAsia News. "And we have the ability to reach the same level as the FDA."

The Shanghai institute also has signed an MOU with the U.S.-based Parenteral Drug Association to establish the SIFDS/PDA Shanghai Joint Development Center to promote information-sharing for pharmaceutical manufacturing quality control and quality assurance (Also see "U.S.-China Groups To Work Together On Pharma Quality Control" - Scrip, 2 October, 2008.).

During the last year, Chinese health regulators have stepped up exchanges with counterparts across the world. Last December, China's Minstry of Health signed an agreement on closer cooperation with the U.S. Department of Health, and U.S. FDA is preparing to open new inspection and cross-training operations in Beijing, Shanghai and Guangzhou (Also see "U.S. FDA Plans Permanent Offices In China In Wake Of Heparin Scare" - Scrip, 17 March, 2008.).

China wants to build a regulatory system that is recognized by its own citizenry and by the peoples across its export markets as being among the world's best, lawyer Bass said. "The Chinese government needs to reassure the Chinese populace that China's standards will provide for safe drugs and medical devices," he said.

And, farther down the road toward globalization, "China is positioning itself to become a major power in the world pharmaceutical sector," said Bass.

- Kevin Holden (pharmasia@elsevier.com)

[Editor's note: PharmAsia News will host a webinar Oct. 15 for pharmaceutical and medical device firms entitled "U.S. FDA Inspections in China." For more information, please click here.]

Focused On Globalization, Shanghai FDA Will Hold International Forum On Drug Safety And Regulatory Change

More from Archive

More from Scrip