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Search for "Post-market Surveillance" related English Translations
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Lastest Update
Supervision and Administration Measures on Cosmetic Manufacture and Operation (Draft for Comments)
Jul 23, 2020
EN
On July 21, 2020, China Ministry of Justice released the draft Supervision and Administration Measures on Cosmetics Manufacture and Operation for public consultation, one of the subsidiary measures of CSAR. The draft consists of 8 chapters with 100 provisions with many details about production license management, production quality management, operation quality management, network operation management, and legal responsibilities. It refines the main responsibilities of the registrants and filers, optimizes the production license management system, strengthens production quality management, refines operation management, clarifies multiple regulatory measures, and refines penalties.*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 1: China Finalized the Long-Awaited Cosmetic Supervision and Administration RegulationNews 2: Finalization of CSAR: A Milestone on Road to Modernization of China's Cosmetic SectorNews 3: Key Points in China Cosmetic Supervision and Administration Regulation (CSAR)News 4: Chinese Cosmetic Officials Disclose the Content and Release Schedule of Subsidiary Regulations of CSARNews 5: Will China Remove Mandatory Animal Testing for Imported General Cosmetics?News 6: CSAR Subsidiary Regulations: China Cosmetics Manufacture and Operation Supervision and Management Measures Unveiled News 7: CSAR Subsidiary Regulations: China Consults on the Draft Administrative Measures on Cosmetic RegistrationWebinar: Understanding China's New Draft Subsidiary Measures of CSARWebinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)English Translation: Cosmetic Supervision and Administration RegulationEnglish Translation: China Administrative Measures on Cosmetic Registration (Draft for Comments)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Pre-market Approval
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
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
Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2019.09.20)
Dec 04, 2018
EN
The document is the enforcement regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Note: This translation was published by Japanese Law Translation and is an unofficial text. The translation is only updated to the 2015 revision while the revised edition of 2019 is in effect. This document should only be used as a reference for understanding Japanese regulations and in case of any discrepancy between the English and Japanese versions the original Japanese version shall prevail.
Japan
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Animal Testing
Enforcement Decree of the Cosmetics Act 30245 (Dec 10, 2019)
Jan 20, 2020
EN
This regulation includes standards for calculation of penalty surcharge, procedures for imposition and collection of penalty surcharges, disposition against payer in arrears of penalty surcharge, publication of relevant violations, delegation of authority, treatment of sensitive information and unique identifiable information, standards for imposition of administrative fines, etc.
South Korea
Post-market Surveillance
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
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
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
Advertising Law of the People's Republic of China
Nov 29, 2019
EN
This Law applies to commercial advertising activities in which commodity dealers or service providers directly or indirectly introduce, via certain media and in certain forms, goods or services marketed by them within the territory of the People's Republic of China.
Chinese Mainland
Post-market Surveillance
Manufacturer/Importer Regulation
Advertising
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
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