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Search for "Post-market Surveillance" related English Translations
29 results found
Most Popular
Lastest Update
Guidelines for Cosmetic Efficacy Claim Evaluation
Sep 07, 2020
EN
Formerly, there were no requirements for other cosmetic efficacy claims except for sunscreens and the waterproof efficacy of sunscreen products. The CSAR released on June 29 stipulates that Efficacy claims of cosmetics should be supported by a sufficient scientific basis.Followed that, China NIFDC released the draft Guidelines for Cosmetic Efficacy Claim Evaluation for public consultation on September 1, 2020. The Guidelines clarify the evaluation principles, exemptions, accepted evaluation methods and institutions, obligations of institutions and registrants/notifiers, necessary content in the evaluation report, 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:[News]CSAR Subsidiary Regulations: Draft Guidelines for Cosmetic Efficacy Claim Evaluation UnveiledChina Consults on the Draft Instruction for New Cosmetic Ingredient Registration and Notification DossiersChina Indicates the End of Mandatory Animal Testing for Imported General CosmeticsChina Consults on the Draft Administrative Measures on Cosmetic RegistrationChina Releases the Draft Cosmetic Classification Rules and CatalogKey Points in China Cosmetic Supervision and Administration Regulation (CSAR)China 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 Translation]Instructions for New Cosmetic Ingredient Registration and Notification DossiersAdministrative Measures on Cosmetic RegistrationCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety Assessment[Featured Page]Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Efficacy
Animal Testing
Safety Assessment
Testing
CSAR
Enterprise Obligations
Instructions for Cosmetic New Ingredient Registration and Notification Dossiers (Draft for Comments)
Sep 03, 2020
EN
On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation, which is one of the subsidiary regulations of CSAR. The Instruction is formulated to guide and regulate the NCI registration and notification in China.Some Key Points of the InstructionDossiers categories required for registration and notification are consistent.Dossiers requirements for nanomaterials and biotechnology sources ingredients are newly added.Conditional acceptance of alternative method data.Detailed test data, laboratory qualification analysis, etc. shall be attached if the safety assessment report is issued by an international authoritative safety assessment agency.*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 Instruction for New Cosmetic Ingredient Registration and Notification DossiersChina Indicates the End of Mandatory Animal Testing for Imported General CosmeticsChina Consults on the Draft Administrative Measures on Cosmetic RegistrationChina Releases the Draft Cosmetic Classification Rules and CatalogKey Points in China Cosmetic Supervision and Administration Regulation (CSAR)China Consults on the Draft Technical Guidelines for Cosmetic Safety Assessment[Webinar]Understanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)[English Translation]Administrative Measures on Cosmetic RegistrationCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety Assessment[Featured Page]Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Pre-market Approval
Ingredients
Post-market Surveillance
CSAR
New Ingredient Management
Enterprise Obligations
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
Administrative Measures on Cosmetic Registration (Draft for Comments)
Jul 23, 2020
EN
On July 21, China Ministry of Justice opened a public consultation on the Administrative Measures on Cosmetic Registration, one of the subsidiary regulations of the Cosmetic Supervision and Administration Regulation (CSAR). The deadline for the consultation is August 20, 2020.The Administrative Measures on Cosmetic Registration clarifies the basic requirements for registration and filing management of cosmetics and new cosmetic ingredients, including some new concepts, "patent protection" for the new ingredients, ingredient traceability management, cosmetic efficacy claims, annual reporting, 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: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 Supervision and Administration Measures on Cosmetics Manufacture and Operation (Draft for Comments)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Pre-market Approval
Ingredients
Post-market Surveillance
Entry-exit
Testing
Pudong Filing
CSAR
New Ingredient Management
Enterprise Obligations
Cosmetic Supervision and Administration Regulation EN
Jul 02, 2020
EN
On Jan.1, 2021, China implemented the final version of Cosmetic Supervision and Administration Regulation.The regulation gives clear provisions for filing or registration of cosmetic ingredients and finished products, production of cosmetics, labeling and advertisement as well as supervision over cosmetics throughout the supply chain. Once this regulation comes into effect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously.Other Languages:Korean Version: Cosmetic Supervision and Administration Regulation$299FreeJapanese Version: Cosmetic Supervision and Administration Regulation$299FreeRelated 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 SectorArticle: Key Points in China Cosmetic Supervision and Administration Regulation (CSAR)Webinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Efficacy
Safety Assessment
CSAR
New Ingredient Management
Enterprise Obligations
Japanese Version: Cosmetic Supervision and Administration Regulation
Jul 01, 2020
日本語&CN
China State Council released the final version of Cosmetic Supervision and Administration Regulation on June 29, 2020 and will implement on January 1, 2021.The regulation gives clear provisions for filing or registration of cosmetic ingredients and finished products, production of cosmetics, labeling and advertisement as well as supervision over cosmetics throughout the supply chain. Once this regulation comes into effect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously.Other Languages:English Version: Cosmetic Supervision and Administration Regulation$299FreeKorean Version: Cosmetic Supervision and Administration Regulation$299FreeRelated 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 SectorWebinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Efficacy
Safety Assessment
CSAR
New Ingredient Management
Enterprise Obligations
Korean Version: Cosmetic Supervision and Administration Regulation
Jul 01, 2020
KR&CN
China State Council released the final version of Cosmetic Supervision and Administration Regulation on June 29, 2020 and will implement on January 1, 2021.The regulation gives clear provisions for filing or registration of cosmetic ingredients and finished products, production of cosmetics, labeling and advertisement as well as supervision over cosmetics throughout the supply chain. Once this regulation comes into effect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously.Other Languages:English Version: Cosmetic Supervision and Administration Regulation$299FreeJapanese Version: Cosmetic Supervision and Administration Regulation$299FreeRelated 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 SectorWebinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
Chinese Mainland
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Efficacy
Safety Assessment
CSAR
New Ingredient Management
Enterprise Obligations
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
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
Interim Provisions on the Administration of Cosmetics Overseas Inspection (Draft)
Nov 26, 2019
EN
The draft regulations specify details on overseas cosmetic inspection procedures, including inspection scope, the competent authority, results, and penalties for violation of the regulation.
Chinese Mainland
Post-market Surveillance
Enterprise Obligations
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