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Search for "Enterprise Obligations" related English Translations
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Technical Guidelines for Determination and Research of New Cosmetic Ingredients (Draft for Comments)
Dec 13, 2023
EN
BackgroundSince the implementation of the Cosmetic Supervision and Administration Regulation (CSAR) in 2021, the China National Medical Product Administration (NMPA) has introduced a risk-based classification system for cosmetic products and NCIs. High-risk NCIs must undergo registration with the NMPA, while low-risk NCIs only need to be notified and can subsequently be manufactured and imported once enterprises complete the online dossier submission. This streamlined process reduces the market entry threshold for NCIs in China. However, challenges have arisen during the registration and notification process for NCIs. Some registrants and notifiers have encountered difficulties due to their incomplete understanding of the identification and categorization of NCIs as well as inadequate data preparation. Common mistakes include the unclear definitions of NCIs, NCIs’ functions exceeding the scope of cosmetic definitions, and the inaccurate determination of applicable situations for NCIs.To standardize and provide guidance for the determination and research of NCIs, the China National Institutes for Food and Drug Control (NIFDC) released the first draft of the Technical Guidelines for Determination of New Cosmetic Ingredients on January 19, 2023, to seek feedback from the public.Taking industry input into account, NIFDC released the second draft, which was renamed to Technical Guidelines for Determination and Research of New Cosmetic Ingredients (Guidelines) on December 1, 2023.The Guidelines is divided into four parts: overview, categorization, general requirements, and explanation of terms. Notifiers and registrants should utilize the Guidelines to assess whether an ingredient belongs to NCI, determine the appropriate NCI category, and conduct research in alignment with the provided requirements.
Chinese Mainland
Pre-market Approval
Ingredients
CSAR
New Ingredient Management
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
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
Regulations on Supervision and Administration of Enterprises in Implementing Entity Responsibility for Cosmetic Quality and Safety
Dec 08, 2022
EN
On November 29, 2022, China National Medical Products Administration (NMPA) launched a public consultation on the draft of Regulations on Supervision and Administration of Enterprises in Implementing Entity Responsibility for Cosmetic Quality and Safety (the Regulations). Consisting of 5 chapters and 33 articles, the draft Regulations specifies the responsibility entities of cosmetic's quality and safety, emphasizes the responsibilities of key positions related to cosmetic quality and safety, as well as clarifies the scope of personnel subject to penalties when certain misconduct happens, and the situations where penalties can be mitigated or exempted.
Chinese Mainland
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
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