On Dec 14, 2018, Shanghai Medical Products Administration released and implemented Specification for Imported Non-Special Use Cosmetics Filing Documents Review (only applicable to non-SUC imported through ports in Shanghai).
Shanghai MPA (SMPA) Technical Review Department collected more than 10,000 opinions gathered by the former CFDA during review of imported non-SUC filing documents 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.
The main contents include:
1) General rule
2) Technical requirements, including requirements for product Chinese name, ingredients, formulation, quality and safety control, packaging, labeling, claims, manufacturing techniques and product testing, etc.
3) Results determination principles
4) Supplementary provisions
Crucial provisions are listed below:
1) Imported non-SUC (including products entrusted by domestic enterprises to be produced by oversea enterprises) that have finished testing for administration license but have not submitted application to NMPA, the testing report still applies to filing in Shanghai.
2) Products that have claims specific to pregnant women, lactating women, children or infants (including products can be used by the whole family) shall also provide documents of product formulation design principles based on safety considerations (including overall analysis report of product formulations), selection criteria and requirements for ingredients, manufacturing technique, quality and safety control.
3) Non-sunscreen products which use an ultraviolet absorber as a protective agent are not subject to limitations imposed on sunscreens as defined by Safety and Technical Standards for Cosmetics, however the concentration of UV absorber should be assessed for safety.
|Packaging (including labels and instructions)||Requirements|
|Claimed as “anti-acne, prevent acne, mite repellent”||Provide testing report for antibiotics and metronidazole|
|Claimed as “anti-dandruff”||Provide testing report for anti-dandruff agents|
|“medicinal” or “medicine” is used to imply efficacy||Shall explain in the product’s Chinese labels or instructions|
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