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Specifications on Imported Non-Special Use Cosmetics Filing Documents Review in Shanghai

Jan 07, 2019
Vicky Sun

On Nov. 9, 2018, China National Medical Products Administration (NMPA) officially announced that registration of first imported non-special use cosmetics will be entirely replaced by filing management nationwide from Nov. 10. Due to the novelty of the new system, authorities in provinces throughout China lack practical experience, prompting both authorities and enterprise alike to turn their attention to Shanghai’s Medical Products Administration, which was the first authority tasked with administrating pilot filing work starting on March 1st, 2017.

On Dec 14, 2018, Shanghai Medical Products Administration (SMPA) released and implemented Specification for initial Imported Non-Special Use Cosmetics Filing Documents Review. SMPA Technical Review Department collected more than 10,000 opinions from the former CFDA in the past 2 years. Combined with experiences gained from implementation of the pilot filing system in Shanghai. SMPA then organized the preparation of Technical Review Specifications with a view to standardizing filing document review.

This specification is of great reference value for stakeholders filing imported non-SUC and is likely to be the reference document guiding development of what will be the  gold standard going forward i.e. Administrative Measures on Filing for Non-Special Use Cosmetics (still in the process).

Compared with the previous filing specification, the requirements have become clearer, more stringent and more specific. This article will offer an in-depth interpretation of this specification. The key points are summarized into 3 aspects, Chinese label, product formula and testing report.

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Tags : Chinese MainlandChildren CosmeticsPre-market ApprovalIngredientsLabeling/Claim/AdvertisingSafety AssessmentTestingPudong Filing
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