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Search for "Pre-market Approval" related English Translations
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Lastest Update
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
Working Rules for Cosmetic Registration and Filing Testing
Sep 30, 2019
EN
On Sept. 10th, 2019, China National Medical Products Administration issued a notice to implement a new testing regulation, Working Rules for Cosmetic Registration and Filing Testing. The Working Rules specify the qualification criteria, responsibilities and supervision requirements of cosmetic testing institutions as well as standard testing procedures and consists of 24 articles and 2 attachments.
Chinese Mainland
Pre-market Approval
Manufacturer/Importer Regulation
Testing
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
Administrative Measures for Filing of Non-special Use Cosmetics (Draft)
Jun 06, 2019
EN
Administrative Measures for Filing of Non-special Use Cosmetics (Draft) aims to standardize the regulation of non-special cosmetics filing nationwide. The draft version has 5 Chapters and 30 Articles with an attachment, mainly involving the filing process, the filing materials, relevant safety assessment and etc.
Chinese Mainland
Pre-market Approval
Animal Testing
Safety Assessment
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
Instructions for Cosmetic Registration and Notification Dossiers (Second Draft for Comment)
Nov 16, 2020
EN
On November 5, 2020, China released the second draft Instructions for Cosmetic Registration and Notification Dossiers for public comments. The new draft of the Instructions for Cosmetic Registration and Notification Dossiers aims to further clarify and refine the provisions in the previous draft and shift the focus of cosmetic supervision from pre-market assessment to in-and post-market management.*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 Deletes One Exceptional Circumstance for Animal Testing ExemptionChina Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of CosmeticsChina 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 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
Chinese Mainland
Children Cosmetics
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Efficacy
Animal Testing
Safety Assessment
Testing
GMP
CSAR
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
Requirements for Filing of Domestic Non-special Use Cosmetic Products
Jan 29, 2015
EN
Since June 30 2015, domestic non-special use cosmetic manufacturers should file product information on-line before placing their products in the market. This regulation stipulates requirements for the filing of all domestic non-special use cosmetics.
Chinese Mainland
Pre-market Approval
Manufacturer/Importer Regulation
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
Pre
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