Chinese manufacturers of certain drugs or active pharmaceutical ingredients selected by FDA will have to meet new registration standards as part of a memorandum of understanding signed Dec. 11 in Beijing by HHS, FDA and China's State Food and Drug Administration.

The MOU outlines a number of specific regulatory and information-sharing actions. On its face, it appears to address a limited number of products entering the U.S., but it reflects a halfway point in a significant cultural bridge, according to an expert on global regulatory issues.

"There is a big difference between having a small list and saying it is a beginning and having a small list and saying it is narrow, and I think it is the former. I don't think it undercuts the seriousness or breadth of [the issue]," Sidley Austin's Scott Bass said in an interview.

Under the agreement, Chinese manufacturers of FDA designated drugs and active pharmaceutical ingredients, including atorvastatin (Pfizer's Lipitor ), sildenafil (Pfizer's Viagra and Revatio ), oseltamivir (Roche's Tamiflu ) and glycerin, must register with SFDA. On its part, SFDA will make inspection and compliance records available to FDA upon request.

The agreement defines a designated drug as any substance that may be used as an API even if the manufacturer does not identify the product as an API. Bass, who heads Sidley Austin's global life sciences team, said, "What's underneath here in part are GMP issues, and part are just adding dangerous ingredients that shouldn't be sold."

FDA Commissioner: Encouraging Developments

"The documents, which were countersigned by the Minister of the General Administration of Quality Supervision, Inspection and Quarantine and the Commissioner of the Chinese State Food and Drug Administration create an incremental, confidence-building system for enforcing compliance with U.S. standards in regulated products before they leave China," FDA Commisioner Andrew von Eschenbach said in a Dec. 14 e-mail to FDA personnel obtained by PharmAsia News.

The agreements require specific actions to be carried out by clear deadlines, and are based on a three-pronged strategy of registration, certification and verification, von Eschenbach said.

"First, the Chinese manufacturers of the agreed-upon items have to register with the appropriate Chinese authorities: AQSIQ if they export food, pet food or food ingredients, and SFDA if they manufacture drugs, dietary supplements and medical devices. The two agencies will share the registration data with FDA, and the food producers must agree to regular inspections to ensure their exports meet the U.S. standards."

"Second, the agreements specify that AQSIQ will certify that the food and feed covered by the agreement meet FDA's standards. SFDA committed to develop a method to provide similar certification for the medical products, which is a significant expansion of their current role of focusing on products for domestic use," he said.

"In addition to these and other public health-protecting measures, our Chinese counterparts have agreed to keep our agency informed of any problems or obstacles in the implementation of the agreements. For example, AQSIQ will notify FDA of those food and feed exporters that fail inspection, explain why it happened, and provide us with the names of firms that have lost their registered status.

"Under the agreements, our inspectors are assured of timely access to Chinese production facilities, if necessary. And I am hopeful that FDA will be able to advance the training of Chinese regulators and aid in the implementation of other provisions of the agreements by establishing a permanent FDA presence in China," von Eschenbach said.

The agencies will release a work plan by April that fleshes out further responsibilities.

Both the U.S. and Chinese agencies pledge to further develop a streamlined process for one agency to conduct an inspection in the other agency's country no later than five days after a request, which Sidley Austin's Bass currently considers unrealistic.

HHS Secretary Mike Leavitt has suggested there will be some resistance to foreign officials having access to U.S. manufacturing facilities (Also see "FDA/China Import Safety MOU Will Be Signed Mid-December" - Pink Sheet, 10 December, 2007., p. 26).

- Daniel Poppy (d.poppy@elsevier.com)

Import Safety Agreement Further Entwines FDA/China Regulatory Process

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