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Search for "GMP" related English Translations
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Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices
Nov 05, 2022
EN
In March 2022, China National Medical Products Administration (NMPA) released the draft Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (Points). Seven months after its release, on October 25, 2022, NMPA released the finalized version, which will take effect on December 1, 2022. Compared to the previous draft, the finalized Points adopts minor amendments. Following the framework set in the draft, it consists of 105 inspection points, and sets separate inspection items for manufacturing and entrusting enterprises. Besides, it introduces the judgment principles of cosmetics regulatory departments, offering enterprises guidance on complying with the Good Manufacturing Practices for Cosmetics.
Chinese Mainland
GMP
Enterprise Obligations
Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (Draft for Comments)
Apr 11, 2022
EN
On January 7, 2022, China NMPA issued the finalized Good Manufacturing Practices for Cosmetics and will implement it on July 1, 2022. Cosmetics registrants, notifiers, and entrusted production enterprises shall organize the cosmetic production in accordance with the Practices. Following that, on March 30, 2022, NMPA released the draft of Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (hereinafter referred to as “Points”) for public consultation. Regulatory authorities across China will use the Points as a basis to determine whether the enterprise complies with GMP. Any suggestions about the Points can be mailed to NMPA (hzpjgc@nmpa.gov.cn) before April 20, 2022.The Points is an upgraded version of Practice for Cosmetics Production Licensing implemented in 2016, with more stringent inspection requirements. The expected effective date of the Points is July 1, 2022, which is the same as that of Good Manufacturing Practices for Cosmetics.Main ContentsThere are a total of 106 articles in the Points, and separate inspection points are set for the manufacturing and entrusting enterprises.1. Applicable Scope2. Inspection Classification and Judgment Principles3. Other MattersAnnex I Inspection Points for Cosmetic Good Manufacturing Practices (For Manufacturing Enterprises)Annex II Inspection Points for Cosmetic Good Manufacturing Practices (For Entrusting Enterprises)
Chinese Mainland
Post-market Surveillance
GMP
CSAR
Enterprise Obligations
Good Manufacturing Practices for Cosmetics
Jan 14, 2022
EN
In September 2020 and 2021, China National Medical Products Administration (NMPA) released the first and the second draft of Good Manufacturing Practices for Cosmetics (hereinafter referred to as “Practices”). After two rounds of public consultation, on January 7, 2022, NMPA released the finalized Practices and will implement it on July 1, 2022.Starting from July 1, 2022, cosmetics registrants, notifiers, and entrusted production enterprises (including cosmetic enterprises that only engage in the preparation of semi-finished products, and toothpaste enterprises) shall organize the cosmetic production in accordance with the Practices. For enterprises that have obtained production licenses before July 1, 2022, if their facilities, equipment, etc., shall be upgraded according to the regulation, the upgrading and reconstruction shall be completed before July 1, 2023.Main ContentsThe Practices are divided into nine chapters with two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. The promulgation of the Practices indicates that cosmetics production in China will enter a more standardized era.Chapter I General RulesChapter II Institutions and PersonnelChapter III Quality Assurance and ControlChapter IV Plant Facilities and Equipment ManagementChapter V Materials and Products ManagementChapter VI Production ManagementChapter VII Entrusted Production ManagementChapter VIII Product Sales ManagementChapter IX Supplementary RulesAnnex I Electronic Record Requirements for Cosmetics ProductionAnnex II Environmental Requirements for Cosmetics Production Plant
Chinese Mainland
GMP
CSAR
Enterprise Obligations
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
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
Good Manufacturing Practices for Cosmetics
Sep 29, 2020
EN
On Sep. 28, 2020, China NMPA released the draft Good Manufacturing Practices for Cosmetics for public consultation, one of the subsidiary regulations of Cosmetic Supervision and Administration Regulation (CSAR). The Practices are divided into nine chapters and two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall.*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 Clarifies the Requirements for Cosmetics GMPDraft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina 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
GMP
CSAR
Enterprise Obligations
Regulations on Cosmetic Good Manufacturing and Quality Control Practices
Feb 14, 2020
EN
This regulation includes terminology and definition, requirements of people, standards of hygiene, storage, package, water used and etc., management of test, sample, waste, after-manufacture and products, judgment and inspection, etc.Note: This translation was published by the Ministry of Food and Drug Safety. This document should only be used as a reference for understanding South Korean regulations and in case of any discrepancy between the English and South Korean version the original version shall prevail.
South Korea
Manufacturer/Importer Regulation
GMP
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