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Lastest Update
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
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
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 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
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 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
Guidance for Cosmetic Safety Risk Assessment (Draft for Comments)
Nov 11, 2015
EN
Purchasers can enjoy the final version for free. On November 10 2015, China Food and Drug Administration released "Guidance for Safety Risk Assessment of Cosmetics" for public consultation. The public consultation will end on Dec 10. When CFDA began to allow the exemption of toxicological testing from June 30th 2014 if safety assessment can fully demonstrate the safety of a domestic-made product, many companies were therefore confused about how to prepare the safety assessment report due to lack of related specific guidelines. With the issuance of this guidance, the situation is expected to change soon.
Chinese Mainland
Animal Testing
Safety Assessment
Testing
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
In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) for Chemicals Used in Cosmetics
Nov 14, 2018
EN
This method specifies the basic principles and test requirements of the transcutaneous electrical resistance test for in-vitro skin corrosion. This method applies to the safety toxicology test of chemicals used in cosmetics.
Chinese Mainland
Animal Testing
Safety Assessment
Testing
In-vitro 3T3 Neutral Red Uptake Phototoxicity Test Method for Chemicals Used in Cosmetics
Nov 14, 2018
EN
This method specifies the scope, normative references, terms and definitions, test principle, test materials and reagents, test procedures and result judgment criteria of in-vitro 3T3 neutral red uptake phototoxicity test for chemicals used in cosmetics. It is recommended that this method applies to the evaluation of the potential phototoxicity of chemicals used in cosmetics.
Chinese Mainland
Animal Testing
Safety Assessment
Testing
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