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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.