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Search for "Post-market Surveillance" related English Translations
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Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (Draft for Comments)
Apr 11, 2022
EN
On January 7, 2022, China NMPA issued the finalized Good Manufacturing Practices for Cosmetics and will implement it on July 1, 2022. Cosmetics registrants, notifiers, and entrusted production enterprises shall organize the cosmetic production in accordance with the Practices. Following that, on March 30, 2022, NMPA released the draft of Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (hereinafter referred to as “Points”) for public consultation. Regulatory authorities across China will use the Points as a basis to determine whether the enterprise complies with GMP. Any suggestions about the Points can be mailed to NMPA (hzpjgc@nmpa.gov.cn) before April 20, 2022.The Points is an upgraded version of Practice for Cosmetics Production Licensing implemented in 2016, with more stringent inspection requirements. The expected effective date of the Points is July 1, 2022, which is the same as that of Good Manufacturing Practices for Cosmetics.Main ContentsThere are a total of 106 articles in the Points, and separate inspection points are set for the manufacturing and entrusting enterprises.1. Applicable Scope2. Inspection Classification and Judgment Principles3. Other MattersAnnex I Inspection Points for Cosmetic Good Manufacturing Practices (For Manufacturing Enterprises)Annex II Inspection Points for Cosmetic Good Manufacturing Practices (For Entrusting Enterprises)
Chinese Mainland
Post-market Surveillance
GMP
CSAR
Enterprise Obligations
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
Measures for the Management of Cosmetic Adverse Reaction Monitoring (Second Draft for Comments)
Oct 08, 2021
EN
On September 28, 2020, China NMPA issued the first draft of Measures for the Management of Cosmetic Adverse Reaction Monitoring. On September 29, 2021, China NMPA promulgated the second draft of Measures for the Management of Cosmetic Adverse Reaction Monitoring (the new Measures) for public comments until October 19. The new Measures includes a total of 7 chapters and 54 articles. Compared to the first draft released in 2020, the second draft is further modified and refined to add clarity and increase the logicality.*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 Starts a New Round of Consultation on Regulations for Cosmetic Adverse Reaction MonitoringChina 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 Ever[English Translation]Good Manufacturing Practices for CosmeticsSupervision and Administration Measures on Cosmetics Manufacture and OperationAdministrative Measures on Cosmetics LabelingTechnical Guidelines for Cosmetic Safety Assessment 2021Cosmetic Classification Rules and Catalogs
Chinese Mainland
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
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
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
Administrative Measures on Cosmetic Registration and Notification
Jan 18, 2021
EN
On December 31, 2020, the draft Administrative Measures on Cosmetic Registration officially passed the State Administration for Market Regulation (SAMR) and was renamed Administrative Measures on Cosmetics Registration and Notification. On January 12, 2021, the finalized regulation's full text was officially published and will take effect on May 1, 2021. The new regulation includes a total of 6 chapters and 63 articles. Compared to the previous draft released in July 2020, the new regulation is further modified and simplified to add clarity and increase the logicality. *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:[News]China Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of CosmeticsChina Consults on the Draft Measures for the Management of Cosmetic Supplementary Testing MethodsChina Deletes One Exceptional Circumstance for Animal Testing ExemptionChina Relaxes Animal Testing Alternatives Use Conditions for New Cosmetic IngredientsChina Amends Requirements for Cosmetic Efficacy Claim EvaluationDraft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMP China to Implement a Cosmetic Sampling Inspection SchemeChina Consults on the Draft Administrative Measures on Cosmetics LabelingChina Releases the Draft Cosmetic Classification Rules and CatalogChina Consults on the Draft Technical Guidelines for Cosmetic Safety Assessment[Free Webinars]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 Dossiers (Draft for Comments)Instructions 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
Testing
CSAR
New Ingredient Management
Enterprise Obligations
Instructions for New Cosmetic Ingredient Registration and Notification Dossiers (Second Draft for Comment)
Nov 13, 2020
EN
On Aug. 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the first draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation. 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 Instructions.Based on the collected public opinions, National Medical Products Administration (NMPA) drafted and released the second edition of the Instructions on Nov. 5. The second draft modifies new cosmetic ingredients registration and notification dossiers requirements and refines the requirements for testing institutions qualification and testing method.*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:[News]China Consults on the draft Measures for the Management of Cosmetic Supplementary Testing MethodsChina Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of CosmeticsChina Modifies Requirements for New Cosmetic Ingredients Registration and Notification DossiersChina Deletes One Exceptional Circumstance for Animal Testing ExemptionChina Amends Requirements for Cosmetic Efficacy Claim EvaluationDraft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMP China to Implement a Cosmetic Sampling Inspection SchemeChina Consults on the Draft Administrative Measures on Cosmetics LabelingChina Consults on the Draft Administrative Measures on Cosmetic RegistrationChina Releases the Draft Cosmetic Classification Rules and CatalogChina Consults on the Draft Technical Guidelines for Cosmetic Safety Assessment[Free Webinars]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 Dossiers (Draft for Comments)Instructions 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[Featured Page]Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Efficacy
Animal Testing
Safety Assessment
Testing
CSAR
New Ingredient Management
Standards for the Management of Cosmetic Sampling Testing (Draft for Comments)
Oct 10, 2020
EN
The Standards for the Management of Cosmetic Sampling Inspection stipulates the requirements and procedures for sampling inspection, and corresponding obligations of all stakeholders.*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:[News]Draft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMPChina to Implement a Cosmetic Sampling Inspection SchemeChina Consults on the Draft Administrative Measures on Cosmetics LabelingDraft Guidelines for Cosmetic Efficacy Claim Evaluation UnveiledChina Indicates the End of Mandatory Animal Testing for Imported General CosmeticsChina Consults on the Draft Instruction for New Cosmetic Ingredient Registration and Notification DossiersChina Consults on the Draft Administrative Measures on Cosmetic RegistrationKey Points in China Cosmetic Supervision and Administration Regulation (CSAR)[Free Webinars]CSAR Series: Deciphering Dossiers Requirements for Cosmetic Registration and NotificationCSAR Series: Understanding Dossiers Requirements for New Cosmetic Ingredient Registration and NotificationUnderstanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation[English Translation]Instructions for Cosmetic Registration and Notification Dossiers (Draft for Comments)Instructions 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[Featured Page]Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Post-market Surveillance
CSAR
Enterprise Obligations
China Measures for the Management of Cosmetic Adverse Reaction Monitoring (Draft for Comments)
Sep 30, 2020
EN
On Sep. 28, 2020, China NMPA released the draft Measures for the Management of Cosmetic Adverse Reaction Monitoring for public consultation. This draft Measure consists of 7 chapters and 49 articles. It specifies the application scope, division of responsibility and specific procedures of cosmetic adverse reaction monitoring.*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:[News]Draft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMPChina to Implement a Cosmetic Sampling Inspection SchemeChina Consults on the Draft Administrative Measures on Cosmetics LabelingDraft Guidelines for Cosmetic Efficacy Claim Evaluation UnveiledChina Indicates the End of Mandatory Animal Testing for Imported General CosmeticsChina Consults on the Draft Instruction for New Cosmetic Ingredient Registration and Notification DossiersChina Consults on the Draft Administrative Measures on Cosmetic RegistrationKey Points in China Cosmetic Supervision and Administration Regulation (CSAR)[Free Webinars]CSAR Series: Deciphering Dossiers Requirements for Cosmetic Registration and NotificationCSAR Series: Understanding Dossiers Requirements for New Cosmetic Ingredient Registration and NotificationUnderstanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation[English Translation]Instructions for Cosmetic Registration and Notification Dossiers (Draft for Comments)Instructions 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[Featured Page]Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Post-market Surveillance
CSAR
Enterprise Obligations
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