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Search for "Pre-market Approval" related English Translations
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Provisions for Application and Acceptance of Administrative Licensing for Cosmetics
Mar 12, 2015
EN
The requirements are applicable to the acceptance work of cosmetic administrative license stipulated in the Regulations concerning the Hygiene Supervision over Cosmetics and its Detailed Rules, are laid down in order to further standardize the application and acceptance of administrative licensing for cosmetics and to guarantee its publicity, fairness and impartiality. The cosmetic administrative license refers to the examination and approval of the use of new cosmetic raw material, production of domestic special cosmetics and the importation of cosmetics for the first time. Besides, the obligations of application, extension, modification, reissue of a hygiene license document (record keeping certificate) are also clearly stated.
Chinese Mainland
Pre-market Approval
Manufacturer/Importer Regulation
Measures for the Metrological Supervision and Administration of Quantitatively Packed Commodities [Effective]
Dec 28, 2017
EN
For the purpose of protecting the lawful rights and interests of consumers, manufacturers and sellers, regulating the metrological supervision and administration of quantitatively packed commodities, these Measures are formulated pursuant to the Metrology Law of the People's Republic of China and by reference to the prevailing international practices. Within the territory of the People's Republic of China, the production and selling of quantitatively packed commodities, and the metrological supervision and administration of quantitatively packed commodities shall be in accordance with these Measures. The term "quantitatively packed commodities" as mentioned in these Measures refers to pre-packed commodities for selling with uniform mass, volume, length, acreage, numbering label and other marks within a certain quantitative scope.
Chinese Mainland
Pre-market Approval
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
Regulations concerning the Hygiene Supervision over Cosmetics
Sep 03, 2014
EN
This regulation stipulates that the state shall exercise hygiene supervision over enterprises engaged in production of cosmetics by means of hygiene license system and the use of new cosmetic raw ingredients, special cosmetics and cosmetics imported into China for the first time must get approval from the health administrative department under the State Council (now CFDA is in charge). Meanwhile, requirements for factory, personnel, raw material, labelling and packaging are put forward.
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
Manufacturer/Importer Regulation
Testing
Advertising
CSAR
Instructions for Toothpaste Notification Dossiers
Jan 27, 2021
EN
According to the Cosmetic Supervision and Administration Regulation (CSAR), toothpaste shall be regulated with reference to regulations on general cosmetics, requiring notification, testing, safety assessment, efficacy evaluation, new toothpaste ingredient application, etc. The toothpaste notifier shall report the manufacture, import, and adverse reaction monitoring of notified toothpaste to the competent authority annually. Instructions for Toothpaste Notification Dossiers are drafted to standardize the toothpaste notification dossiers in China.*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 Instructions for Toothpaste Notification Dossiers Require Mandatory Efficacy Evaluation and Safety AssessmentChina Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina’s Long-Anticipated Cosmetic Supervision and Administration Regulation (CSAR) Officially Takes EffectChina Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of CosmeticsChina 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 Assessment[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]Administrative Measures on Cosmetic Registration and NotificationAdministrative Measures on Toothpaste Instructions for Cosmetic Registration and Notification DossiersInstructions for New Cosmetic Ingredient Registration and Notification DossiersCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety AssessmentAdministrative Measures on Cosmetic Labeling
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
Efficacy
Safety Assessment
CSAR
Toothpaste
Good Manufacturing Practices for Cosmetics (Second Draft for Comments)
Sep 13, 2021
EN
On Sep. 28, 2020, China NMPA released the first draft of Good Manufacturing Practices (GMP) for Cosmetics. On Sep. 8, 2021, China NMPA consults on the second draft of Good Manufacturing Practices for Cosmetics (the Practices). The number of articles in the second draft is reduced from 77 to 64, and some standards are relaxed.Domestic cosmetic registrants, notifiers, and entrusted production enterprises should organize the cosmetics production in accordance with the requirements of the Good Manufacturing Practices for Cosmetics. The Practices are divided into 9 chapters and 2 annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. As the second draft mentions that the regulation’s effective date is Jan. 1, 2022, it is expected that its finalized version will be issued before 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 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 EverChina Publicizes the First Notification of a New Cosmetic Ingredient[English Translation]Supervision and Administration Measures on Cosmetics Manufacture and OperationAdministrative Measures on Cosmetics LabelingTechnical Guidelines for Cosmetic Safety Assessment 2021Cosmetic Classification Rules and Catalogs
Chinese Mainland
Pre-market Approval
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
Management Requirements for Sun-protection Effect Labeling of Sunscreen Cosmetics
Nov 14, 2018
EN
This standard specifies the management requirements of sun-protection effect labeling for sunscreen cosmetics.
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
Regulations for Issuance of Permit License of Specific Purpose Cosmetics
Jul 19, 2019
EN
The regulation specifies the definition of specific purpose cosmetics as well as the application dossiers requirements for cosmetic special-use certificate application, change and extension. The main contents include:Legal basisTerminologiesDossiers necessary for special-use cosmetics certificates applicationInadmissible conditions for special-use certificate applicationProcedures for applying for certificate changes, cancellation, etc.
Taiwan, China
Pre-market Approval
Guidance on Application and Review of Children's Cosmetics
Sep 03, 2014
EN
China cosmetics regulation Guidance on Application and Review of Children's Cosmetics clearly defined what is "children cosmetics" in China: cosmetics used for children not older than 12 years old. Therefore, manufacturers involved in the production of this kind of products are regulated by this new guidance. The main content consists of principles for designing the product formula, safety evaluation of finished products and ingredients, application requirements and key points for technical review.
Chinese Mainland
Children Cosmetics
Pre-market Approval
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