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Search for "Pre-market Approval" related English Translations
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Lastest Update
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
Supervision and Administration Provisions on Children Cosmetics
Oct 19, 2021
EN
On Jun. 18, 2021, China NMPA issued the draft Supervision and Administration Provisions on Children Cosmetics. On Oct. 8, 2021, China NMPA promulgated the finalized version of Supervision and Administration Provisions on Children Cosmetics. Except for labeling requirements, other requirements in the finalized Provisions will come into force on Jan. 1, 2022.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related Resoucres[Featured Page] Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking[News]China to Implement the First Children Cosmetics Regulation in 2022China Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision EverInfant and Children Cosmetics Face Stricter Supervision in China[Cosmepedia]China Children Cosmetics RegulationChina Cosmetics Regulation
Chinese Mainland
Children Cosmetics
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
CSAR
Enterprise Obligations
COSMETICS ACT No.18448
Sep 15, 2021
EN
This Act is the overarching regulation for cosmetics in South Korea, providing measures for the manufacture, import and sale of cosmetics and cosmetic ingredients, including detailed requirements for the labeling and advertising of products, custom cosmetics definition and categories, etc.
South Korea
Natural/Organic
Children Cosmetics
Custom Cosmetics
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Good Manufacturing Practices for Cosmetics (Second Draft for Comments)
Sep 13, 2021
EN
On Sep. 28, 2020, China NMPA released the first draft of Good Manufacturing Practices (GMP) for Cosmetics. On Sep. 8, 2021, China NMPA consults on the second draft of Good Manufacturing Practices for Cosmetics (the Practices). The number of articles in the second draft is reduced from 77 to 64, and some standards are relaxed.Domestic cosmetic registrants, notifiers, and entrusted production enterprises should organize the cosmetics production in accordance with the requirements of the Good Manufacturing Practices for Cosmetics. The Practices are divided into 9 chapters and 2 annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. As the second draft mentions that the regulation’s effective date is Jan. 1, 2022, it is expected that its finalized version will be issued before 2022.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related Resoucres[Featured Page] Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking[News] China NMPA Consults on the Second Draft of Good Manufacturing Practices for CosmeticsChina to Implement Supervision and Administration Measures on Cosmetics Manufacture and OperationChina Formally Implements A Brand-new Cosmetic and New Cosmetic Ingredients Pre-market Approval System on May 1China Implements Amended Cosmetic Prohibited Ingredient Inventories: 24 Newly Prohibited Ingredients Including Cannabidiol (CBD)China Releases the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021)Detailing China’s Requirements for Cosmetic Quality and Safety DirectorsChina Finalizes Requirements for Cosmetic LabelingChina Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision EverChina Publicizes the First Notification of a New Cosmetic Ingredient[English Translation]Supervision and Administration Measures on Cosmetics Manufacture and OperationAdministrative Measures on Cosmetics LabelingTechnical Guidelines for Cosmetic Safety Assessment 2021Cosmetic Classification Rules and Catalogs
Chinese Mainland
Pre-market Approval
GMP
CSAR
Enterprise Obligations
Supervision and Administration Measures on Cosmetics Manufacture and Operation
Aug 10, 2021
EN
On Aug. 2, 2021, China State Administration for Market Regulation released the finalized Supervision and Administration Measures on Cosmetics Manufacture and Operation, which will come into force on Jan. 1, 2022.The Measures consists of 7 chapters with 66 provisions, detailing cosmetic manufacture and operation management. Highlights include:Optimizing production license management system;Refining and clarifying the production management requirements;Refining and clarifying the operation management requirements;Strengthening the supervisory responsibilities of the administration department.In addition, detailed requirements have been made for issues of concern, such as the responsibilities and qualification requirements for the person in charge of quality and safety, the requirements for operators in e-commerce platforms, etc.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related Resources[Featured Page] Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking[News]China to Implement Supervision and Administration Measures on Cosmetics Manufacture and OperationChina Formally Implements A Brand-new Cosmetic and New Cosmetic Ingredients Pre-market Approval System on May 1China Implements Amended Cosmetic Prohibited Ingredient Inventories: 24 Newly Prohibited Ingredients Including Cannabidiol (CBD)Detailing China’s Requirements for Cosmetic Quality and Safety DirectorsChina Finalizes Requirements for Cosmetic LabelingChina Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision EverChina Publicizes the First Notification of a New Cosmetic Ingredient
Chinese Mainland
Children Cosmetics
Pre-market Approval
Post-market Surveillance
CSAR
Enterprise Obligations
Technical Guidelines for Cosmetic Safety Assessment
Apr 21, 2021
EN
On Jul. 29, 2020, China opened a public consultation on Technical Guidelines for Cosmetic Safety Assessment. On Apr. 9, 2021, the finalized Technical Guidelines for Cosmetic Safety Assessment was officially published and will take effect on May 1, 2021. The Technical Guidelines clarify the detailed requirements for conducting safety assessment, requirements for safety assessors, content necessary in the assessment report, attach corresponding samples, and set transitional measures.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related ResourcesIn order to stay fully up-to-date with the changes and the ongoing announcements around CSAR and its sub-regulations, remember to bookmark and tune in to ChemLinkeds' comprehensive and detailed CSAR homepage.[Featured Page]Catch the Significant Moments: China Cosmetic Regulatory Reform Tracking[News]China Details Cosmetic Safety Assessment RequirementsChina Unveils the Cosmetic Classification Rules and CatalogsChina Finalizes Standards for Cosmetic Efficacy Claim EvaluationChina NMPA Answers FAQs about Cosmetics Registration and NotificationChina Introduces Transitional Measures to Implement the New Provisions on Cosmetic Registration and Notification DossiersChina Finalizes Dossier Requirements for Registration and Notification of Cosmetics and New Cosmetic IngredientsChina Instructions for Toothpaste Notification Dossiers Require Mandatory Efficacy Evaluation and Safety AssessmentChina Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina’s Long-Anticipated Cosmetic Supervision and Administration Regulation (CSAR) Officially Takes Effect[Free Webinar Series]Prepare for Cosmetic Registration and Notification under China's New RegulationsGet Ready for China’s New Cosmetic Ingredient Registration and NotificationExpert Interview: Detailing Ingredient Submission Code Required for Cosmetic Registration and Notification[English Translations]Provisions for Management of Cosmetic Registration and Notification DossiersProvisions for Management of New Cosmetic Ingredient Registration and Notification DossiersAdministrative Measures on Cosmetic Registration
Chinese Mainland
Pre-market Approval
Safety Assessment
Testing
CSAR
Enterprise Obligations
Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers
Mar 10, 2021
EN
After two rounds of public consultation, on Mar. 4, 2021, China NMPA finally released the finalized Instructions for New Cosmetic Ingredient Registration and Notification Dossiers and renamed it as Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers. The registration and notification dossiers of a natural or artificial ingredient that is applied in cosmetic products for the first time in China shall meet the requirements stipulated in the Provisions.The Provisions are scheduled to come into force on May 1, 2021. Starting from the date, companies shall submit the registration/notification dossiers in accordance with the requirements specified in the Provisions.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related ResourcesIn order to stay fully up-to-date with the changes and the ongoing announcements around CSAR and its sub-regulations, remember to bookmark and tune in to ChemLinkeds' comprehensive and detailed CSAR homepage.[Featured Page]Catch the Significant Moments: China Cosmetic Regulatory Reform Tracking[News]China’s Long-Anticipated Cosmetic Supervision and Administration Regulation (CSAR) Officially Takes EffectChina Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina Finalizes Dossier Requirements for Registration and Notification of Cosmetics and New Cosmetic IngredientsChina to Exempt Animal Testing for Imported General Cosmetics on May 1China Introduces Transitional Measures to Implement Cosmetic Supervision and Administration RegulationChina Consults on the Draft Administrative Measures on Cosmetics LabelingChina Amends Requirements for Cosmetic Efficacy Claim EvaluationChina Consults on the Draft Technical Guidelines for Cosmetic Safety AssessmentDraft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMPChina to Implement a Cosmetic Sampling Inspection SchemeChina Releases the Draft Cosmetic Classification Rules and CatalogChina Consults on the Draft Measures for the Management of Cosmetic Supplementary Testing Methods [Free Webinar Series]CSAR Series: Deciphering Dossiers Requirements for Cosmetic Registration and NotificationCSAR Series: Understanding Dossiers Requirements for New Cosmetic Ingredient Registration and NotificationCSAR Exclusive Interview: Animal Testing, New Ingredients and What Next?Understanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation[English Translations]Instructions for Cosmetic Registration and Notification DossiersInstructions for New Cosmetic Ingredient Registration and Notification DossiersAdministrative Measures on Cosmetic RegistrationCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety AssessmentAdministrative Measures on Cosmetic Labeling
Chinese Mainland
Pre-market Approval
Ingredients
Post-market Surveillance
Efficacy
Animal Testing
Safety Assessment
Testing
CSAR
New Ingredient Management
Provisions for Management of Cosmetic Registration and Notification Dossiers
Mar 10, 2021
EN
After two rounds of public consultation, on Mar. 4, 2021, China NMPA finally released the finalized Instructions for Cosmetic Registration and Notification Dossiers and renamed it as Provisions for Management of Cosmetic Registration and Notification Dossiers. The Provisions detail the documentation requirements for the application, modification, renewal, and cancellation of cosmetic registration/notification.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related ResourcesIn order to stay fully up-to-date with the changes and the ongoing announcements around CSAR and its sub-regulations, remember to bookmark and tune in to ChemLinkeds' comprehensive and detailed CSAR homepage.[Featured Page]Catch the Significant Moments: China Cosmetic Regulatory Reform Tracking[News]China’s Long-Anticipated Cosmetic Supervision and Administration Regulation (CSAR) Officially Takes EffectChina Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina Introduces Transitional Measures to Implement Cosmetic Supervision and Administration RegulationChina Consults on the Draft Administrative Measures on Cosmetics LabelingChina Amends Requirements for Cosmetic Efficacy Claim EvaluationChina Consults on the Draft Technical Guidelines for Cosmetic Safety AssessmentDraft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMPChina to Implement a Cosmetic Sampling Inspection SchemeChina Releases the Draft Cosmetic Classification Rules and CatalogChina Consults on the Draft Measures for the Management of Cosmetic Supplementary Testing Methods [Free Webinar Series]CSAR Series: Deciphering Dossiers Requirements for Cosmetic Registration and NotificationCSAR Series: Understanding Dossiers Requirements for New Cosmetic Ingredient Registration and NotificationCSAR Exclusive Interview: Animal Testing, New Ingredients and What Next?Understanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation[English Translations]Instructions for Cosmetic Registration and Notification DossiersInstructions for New Cosmetic Ingredient Registration and Notification DossiersAdministrative Measures on Cosmetic RegistrationCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety AssessmentAdministrative Measures on Cosmetic Labeling
Chinese Mainland
Pre-market Approval
Animal Testing
Instructions for Toothpaste Notification Dossiers
Jan 27, 2021
EN
According to the Cosmetic Supervision and Administration Regulation (CSAR), toothpaste shall be regulated with reference to regulations on general cosmetics, requiring notification, testing, safety assessment, efficacy evaluation, new toothpaste ingredient application, etc. The toothpaste notifier shall report the manufacture, import, and adverse reaction monitoring of notified toothpaste to the competent authority annually. Instructions for Toothpaste Notification Dossiers are drafted to standardize the toothpaste notification dossiers in China.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related Resources[Featured Page]Catch the Significant Moments: China Cosmetic Regulatory Reform Tracking[News]China Instructions for Toothpaste Notification Dossiers Require Mandatory Efficacy Evaluation and Safety AssessmentChina Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina’s Long-Anticipated Cosmetic Supervision and Administration Regulation (CSAR) Officially Takes EffectChina Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of CosmeticsChina Consults on the Draft Administrative Measures on Cosmetics LabelingChina Amends Requirements for Cosmetic Efficacy Claim EvaluationChina Consults on the Draft Technical Guidelines for Cosmetic Safety Assessment[Free Webinar Series]CSAR Series: Deciphering Dossiers Requirements for Cosmetic Registration and NotificationCSAR Series: Understanding Dossiers Requirements for New Cosmetic Ingredient Registration and NotificationCSAR Exclusive Interview: Animal Testing, New Ingredients and What Next?Understanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation[English Translations]Administrative Measures on Cosmetic Registration and NotificationAdministrative Measures on Toothpaste Instructions for Cosmetic Registration and Notification DossiersInstructions for New Cosmetic Ingredient Registration and Notification DossiersCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety AssessmentAdministrative Measures on Cosmetic Labeling
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
Efficacy
Safety Assessment
CSAR
Toothpaste
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