BEIJING - A new government think tank focused on health-sector regulatory reform and international cooperation set up by the Shanghai FDA will work closely with a U.S.-based law firm to review drug laws worldwide and to host a series of global exchanges.

The leaders of the new think tank, the Shanghai Institute for Food & Drug Safety, have signed an agreement with the international firm Sidley Austin. The pact states the two sides will jointly "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."

"This is a ground-breaking agreement," said Scott Bass, who heads the global life sciences team at Sidley's Washington, D.C office.

The two sides have forged "an informal strategic alliance" to review American and European drug laws and court decisions as Shanghai regulators prepare to rewrite food and pharmaceutical safety legislation, said lawyer Bass.

The new alliance is part of the Chinese government's strengthening initiative to improve its regulation of the pharmaceutical and medical device industries and its image at home and abroad.

"China has embarked on a strong and fast-paced program to better regulate drugs and medical devices," noted Bass.

"The Chinese government needs to reassure the Chinese public that its standards will provide for safe medicines and medical devices," he said in an interview. And to pave the way for expanding exports of pharmaceuticals and active pharmaceutical ingredients, health officials "want international input on creating a state-of-the-art regulatory system," he added.

The Shanghai Institute will be granted considerable leeway "to cooperate with outside groups," Bass explained.

The pact signed by the institute's leaders and the law firm, which also has offices in Beijing and Shanghai, provides the Chinese and American partners will help set up international exchanges focused on drug laws and "arrange legal training of food, drug and medical device personnel."

One of the heads of the Shanghai FDA said regulators had selected the law firm "because Sidley has rich experience in drug regulation worldwide and has a strong life sciences team."

Not Just Window Dressing

China's international image on drug regulation and safety standards suffered after the raw ingredients for the blood thinner heparin produced in China triggered a sharp spike in adverse drug reactions in the United States starting in late 2007 (Also see "U.S. FDA Triples Estimate On Deaths Following Allergic Reaction To Blood Thinner Heparin" - Scrip, 14 April, 2008.).

The SFDA was initially perceived as hesitant to cooperate with FDA investigators into the source of the contaminated ingredients or to publicly disclose details of the case.

But since then, Chinese health officials have moved to rapidly improve the image of the SFDA, transparency on adverse drug reactions, and willingness to cooperate with regulators in major export markets (Also see "U.S. FDA Plans Permanent Offices In China In Wake Of Heparin Scare" - Scrip, 17 March, 2008.).

After signing an agreement in December with American health regulators on closer cooperation in the monitoring and trade of medicines, the Chinese government is now in the final stages of approving a plan for the U.S. FDA to set up offices in Beijing, Shanghai and Guangzhou (Also see "U.S. FDA Plans Permanent Offices In China In Wake Of Heparin Scare" - Scrip, 17 March, 2008.).

The creation of the Shanghai Institute for Food & Drug Safety and its mandate on cross-border collaboration "reflects the globalization of the Chinese drug and medical device market," Bass said.

"Chinese manufacturers wish to export more globally, and need to provide proof that Chinese regulations will provide for a high level of safety," he explained. The same rationale holds for mutlinational pharmaceutical firms that have set up clinical trials and manufacturing operations in China.

As part of the new drive toward global consultations in reforming parts of China's regulatory system, the Shanghai Institute will host its first international forum on the drug industry and laws in October. Scholars and regulators from across the world will be invited to give talks and present papers at the forum.

The Shanghai think tank is spearheading an "effort to take account of other law systems, which could become a catalyst for change," said Bass.

"China is investing a lot of money into research in innovative pharmaceuticals and biologics, and time into intellectual property provisions that will foster innovative drugs," said Bass.

This growing emphasis on innovative drugs, combined with a revamped drug regulatory framework that vies with the best worldwide, is helping China position itself ultimately to become a major power in terms of exports of pharmaceuticals and medical devices, he said.

- Kevin Holden (pharmasia@elsevier.com)

Shanghai FDA Signs Agreement With U.S. Law Firm To Foster International Cooperation on Drug Regulation

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