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China: CFDA Publishes 2018 Roadmap for Regulatory Rulemaking

Monday, February 12, 2018: The China Food and Drug Administration (CFDA) has released its legislative program for 2018. CFDA’s roadmap for the year features almost 40 new or revised laws, regulations and guidance documents.

Most of the activity relates to guidance documents. Revisions to texts covering the registration of medical devices and in vitro diagnostics are due later this year, as are new and updated texts about a range of big topics facing CFDA’s drug department. The drug department’s roadmap includes revisions to good clinical practices and registration, plus the development of documents on pharma inspections and data practices.

On the legal front, China is looking at its drug administration law and pharmaceutical patent regime. CFDA is also working on changes to three groups of regulations, including the document covering the supervision of medical devices.

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