On Aug 5, 2013, the China Food and Drug Administration (CFDA) opened its draft Rules of the China Food and Drug Administration Legislation Procedure (the “Draft”) for public comment. The CFDA provided one month (August 5-September 5) to submit opinions on the new rules in the Draft. The Draft states the purposes of the new Rules are to regulate legislative procedures, guarantee the quality of legislation, and improve the efficiency of the legislation.

To that end, the Draft sets forth a wide variety of general rules, including those governing initiating a project as well as laws pertinent to drafting, reviewing, deliberating, publicizing, filing, interpreting, evaluating and  abolishing existing laws, regulations and rules.

The Draft provides that the pertinent government department responsible for drafting laws and rules shall solicit opinions from other government agencies, organizations, and local enforcement officers as well as the public. We expect that the new “Rules” will provide the public, including foreign healthcare and pharmaceutical companies, opportunities to participate in the CFDA’s legislative process and voice their opinions and interests.

To date, the CFDA has not publicized comments or opinions received or its responses to those materials.  However, Husch Blackwell is monitoring this issue for further information as it becomes available.

For additional information, please contact Zheng Xie, Robert Stang, Carlos Rodriguez or Joe Orlet.

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Photo of Zheng Xie Zheng Xie

Zheng is a recognized expert across a range of U.S. and Chinese legal and business issues. She focuses on corporate and regulatory matters associated with  international trade transactions and litigation, as well as licensing issues within the Departments of Commerce and State.

Photo of Robert Stang Robert Stang

Bob focuses his practice on customs and international trade law. He brings 30 years of experience to a wide range of issues that affect inbound and outbound goods, including tariff classification, valuation, country of origin marking matters, free trade agreements, and special trade programs. He also has extensive customs compliance experience and regularly assists importers facing U.S. Customs and Border Protection (CBP) audits, penalties, seizures, redelivery notices and other agency enforcement activities. Bob works with importers and exporters proactively to achieve cost savings and structure programs that meet CBP “reasonable care” requirements. He also handles supply chain security issues, including Customs-Trade Partnership Against Terrorism (C-TPAT) enrollment, verification and annual reviews.

Photo of Carlos Rodriguez Carlos Rodriguez

A member of the Technology, Manufacturing & Transportation team, Carlos concentrates his practice in international and domestic transportation law. He skillfully navigates his maritime clients through the complexities of regulation and compliance in matters administered by U.S. Customs and Border Protection (CBP), the Transportation Security Administration (TSA) and other governing bodies. He also coordinates global and U.S. acquisitions and mergers of multinational companies.