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The latest version of “Detailed Guidance for Health Food Registration Approval” was released recently (see CL news report on Nov. 18, 2016). The guidance has helped to detail new health food registration procedures and clarified compliance and regulatory requirements related to the qualifications of health food registration applicants, data traceability, procedure optimization, etc.
The applicants for registration of imported health food should be the listed overseas health food manufacturers, and relevant qualification certificates should be provided.
New requirements for data traceability
Traceability of health food application dossiers has been emphasized in the new regulation, along with a new requirement to keep R&D data for longer. The applicant is required to provide R&D results, as well as supporting scientific evidence. The applicant should also keep a record of all individuals involved in the research and keep all original data including R&D trial data and records, pilot scale production records, etc.
Shortened timeline for health food registration approval
It is stipulated in the new regulation that the overall timeframe for health food registration approval will be greatly shortened compared to the current registration procedure. Under the new system approvals can be granted within 170 working days, including the time required for application dossier examination (60 working days), field inspection (30 days), 60 reexamination (60 days reexamination), and administrative examination (20 days).
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