NMPA Announcement No. 70 updates cosmetics registration and filing dossiers

A first-launch statement can replace proof of overseas sale for international new products

NMPA Announcement No. 70 allows a registrant or filer of an international cosmetics product first launched in China, or launched simultaneously in China and another country or region, to submit a statement undertaking the product’s first launch in China. The statement replaces proof that the product has already been marketed in the registrant’s or filer’s country or region, or in the country or region of manufacture. A design drawing may be used for the sales packaging submitted for the registration or filing.

Some products may omit toxicology reports and ingredient safety codes are no longer entered

For hair perming products, non-oxidative hair dyes, physically covering skin-lightening products and general cosmetics using new ingredients, a toxicology report may be omitted when the manufacturer has a government-issued quality-system qualification from the relevant country or region and the safety assessment adequately confirms product safety. Registrants and filers also no longer need to enter ingredient safety-information files or ingredient submission codes; they enter the ingredient manufacturer’s name and retain the supporting files. A change to the ingredient manufacturer or quality specification still requires maintenance or a change application under the applicable rules.

Similar formula systems may share testing and efficacy data under conditions

For multiple products under one brand with similar formula systems, the registrant or filer may select a representative product for microbiological and physicochemical testing, toxicology testing and human safety testing. Other products may share those reports after submitting an explanation of formula similarity and confirming that the shared reports are scientifically and reasonably applicable. Similar products may also share efficacy-evaluation data after an equivalence assessment and disclosure in the published summary. Special efficacy claims for skin lightening, sun protection and hair loss prevention remain subject to the specific submission requirements.

Changes to sites, efficacy methods and domestic responsible persons are simplified

When a registered or filed product moves between domestic and overseas manufacturing sites or adds a manufacturer without substantive changes to the registrant or filer, product name, formula or applicable standard, certain toxicology, human-safety, safety-assessment and efficacy reports may be shared. Microbiological and physicochemical testing must be performed again. Except for skin lightening, sun protection and hair-loss prevention, other efficacy claims may use an industry or international standard, a technical guide or a validated in-house method when supported by sufficient scientific evidence. A domestic responsible-person change requires the authorization and notarization documents, product list and undertaking, instead of the former consent statement or judgment document.