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Search for "Pre-market Approval" related English Translations
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Enforcement Decree of the Cosmetics Act (Presidential Decree No.32445, Feb. 15, 2022)
Nov 25, 2019
EN&KR
The purpose of this decree is to prescribe matters delegated by the Cosmetics Act and other matters necessary for the enforcement.This regulation includes:Detailed types and scope of businessStandards for calculation of penalty surchargeProcedures for imposition and collection of penalty surchargesDisposition against payer in arrears of penalty surchargePublication of relevant violationsDelegation of authority, treatment of sensitive information and unique identifiable informationStandards for imposition of administrative finesEnforcement date
South Korea
Pre-market Approval
Post-market Surveillance
Technical Guidelines for Determination and Research of New Cosmetic Ingredients (Draft for Comments)
Dec 13, 2023
EN
BackgroundSince the implementation of the Cosmetic Supervision and Administration Regulation (CSAR) in 2021, the China National Medical Product Administration (NMPA) has introduced a risk-based classification system for cosmetic products and NCIs. High-risk NCIs must undergo registration with the NMPA, while low-risk NCIs only need to be notified and can subsequently be manufactured and imported once enterprises complete the online dossier submission. This streamlined process reduces the market entry threshold for NCIs in China. However, challenges have arisen during the registration and notification process for NCIs. Some registrants and notifiers have encountered difficulties due to their incomplete understanding of the identification and categorization of NCIs as well as inadequate data preparation. Common mistakes include the unclear definitions of NCIs, NCIs’ functions exceeding the scope of cosmetic definitions, and the inaccurate determination of applicable situations for NCIs.To standardize and provide guidance for the determination and research of NCIs, the China National Institutes for Food and Drug Control (NIFDC) released the first draft of the Technical Guidelines for Determination of New Cosmetic Ingredients on January 19, 2023, to seek feedback from the public.Taking industry input into account, NIFDC released the second draft, which was renamed to Technical Guidelines for Determination and Research of New Cosmetic Ingredients (Guidelines) on December 1, 2023.The Guidelines is divided into four parts: overview, categorization, general requirements, and explanation of terms. Notifiers and registrants should utilize the Guidelines to assess whether an ingredient belongs to NCI, determine the appropriate NCI category, and conduct research in alignment with the provided requirements.
Chinese Mainland
Pre-market Approval
Ingredients
CSAR
New Ingredient Management
Enterprise Obligations
Technical Guidelines for Children Cosmetics (Draft for Comments)
Apr 20, 2022
EN
China’s first regulation on children cosmetics, Supervision and Administration Provisions on Children Cosmetics (hereafter referred to as “Provisions”), came into effect on Jan. 1, 2022. Four months later, on Apr. 11, 2022, China National Institutes for Food and Drug Control released the draft of Technical Guidelines for Children Cosmetics (hereafter referred to as “Guidelines”) for public consultation. Any suggestions can be mailed to hzppjzx@nifdc.org.cn before Apr. 28, 2022.Main ContentThe Guidelines is formulated to provide technical guidance for the registrant, notifier, and Chinese domestic responsible person when applying for the registration and notification of children cosmetics, as well as provide the basis for the competent authorities’ technical review of special children cosmetics and post-notification review of general children cosmetics. The Guidelines consists of 7 parts and an annex:1. Basic Requirements2. Requirements for Product Name and Related Dossiers3. Requirements for Product Formula and Ingredient Use4. Requirements for Product Executive Standard5. Labeling Requirements6. Requirements for Product Testing Report7. Requirements for Product Safety Assessment ReportAnnex: 26 Fragrance AllergensIt is worth noting that the Guidelines clarifies the specific requirements for safety assessment, products designed for the Chinese market, children sunscreens; more stringent requirements for ingredient use, labeling, and claims, etc. The Guidelines is in the process of translation and will be available on Apr. 20.
Chinese Mainland
Children Cosmetics
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Efficacy
Safety Assessment
CSAR
Pre
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