The proposed revision to “Administrative Measures for Registration of Foods for Special Medical Purpose” involves the onsite inspection requirements, principle of clinical trial, product supervision, registration modification & renewal. The priority review and approval procedure is newly set, which applies to food for special medical purposes products for rare diseases or in urgent clinical demand.
On Oct 18, 2021, State Administration for Market Regulation (SAMR) unveiled the exposure draft of “Administrative Measures for Registration of Foods for Special Medical Purpose”. Any comments should be sent back prior to Nov. 18, 2021 via http://www.moj.gov.cn, http://www.chinalaw.gov.cn, http://www.samr.gov.cn, or sending e-mail to tsspsypzcc@samr.gov.cn.
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