The Chinese government is currently taking steps to strengthen CFDA’s authority as an agency within the Chinese government, while at the same time increasing regulatory transparency.  As part of this effort, the China Food & Drug Administration (CFDA) recently issued a proposed rule (Draft Rule) to revise its 2002 Provisions on Legislative Procedures, which sets out the processes that will be used by CFDA to issue or amend rules and guidance documents.

The Draft Rule would, among other things, establish new ways for stakeholders to participate in the rulemaking process, enhance the status of guidance documents, and formalize certain pre-existing procedures.  For example, the Draft Rule allows stakeholders to participate through opportunities for notice and comment and by proposing new areas for rulemaking.  The Draft Rule also places greater emphasis on the importance of drafting practical regulations through in depth research.  As part of the rulemaking process, drafters must engage in thorough research of the current regulatory problem, the regulatory history, and other prior experience dealing with the issue both in China and overseas.  For these reasons, life sciences companies with products regulated by CFDA in China should consider submitting comments and should closely monitor the development of the Draft Rule.  The agency will accept public comments on the Draft Rule through September 5, 2013.

Overall, the Draft Rule is evidence of efforts to reform both CFDA itself and the substantive content of food, drug, device, and cosmetics law and regulation in China.  The Draft Rule also reflects broader trends in administrative regulation in China, such as increased transparency, stakeholder participation, and reform of inter-agency relations.  Once CFDA receives comments, it will consider them and may revise the Draft Rule.  There is no deadline for the Draft Rule’s promulgation.

For more information about the Draft Rule, including a discussion of its significant features, please see our full client alert.