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Search for "Pre-market Approval" related English Translations
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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 Once this regulation comes into effect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously.Other Languages:English Version: Cosmetic Supervision and Administration Regulation$299FreeJapanese Version: Cosmetic Supervision and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
Enforcement Decree of the Cosmetics Act (Presidential Decree No.32445, Feb. 15, 2022)
Nov 25, 2019
EN&KR
The purpose of this decree is to prescribe matters delegated by the Cosmetics Act and other matters necessary for the enforcement.This regulation includes:Detailed types and scope of businessStandards for calculation of penalty surchargeProcedures for imposition and collection of penalty surchargesDisposition against payer in arrears of penalty surchargePublication of relevant violationsDelegation of authority, treatment of sensitive information and unique identifiable informationStandards for imposition of administrative finesEnforcement date
South Korea
Pre-market Approval
Post-market Surveillance
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
Regulations for Reporting Cosmetics Serious Adverse Effects and Hazards to Hygiene and Safety
Jul 22, 2019
EN
The regulation stipulates the target to notify, the method and content of adverse event notification. If severe adverse events occur or the product is found to be harmful to human health, it shall be notified on the online system established by the central competent authority within 15 days (in an emergency, manufacturers can notify it verbally). The credentials, dossiers or data shall be kept for at least 5 years.
Taiwan, China
Pre-market Approval
Post-market Surveillance
Regulations for Cosmetic Product Information File Management
Jul 19, 2019
EN
The regulation specifies information about how to build product information file(PIF), including qualifications of the manufacturer and importer who can establish the PIF, documents required for PIF, the time PIF should be kept, the qualifications for product safety data signers, etc.
Taiwan, China
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Safety Assessment
Testing
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
Regulation for Authorizing the Applications of Import of Non-licensed Specific Purpose Cosmetics
Jul 19, 2019
EN
The regulation specifies the requirements for the import application of non-licensed specific purpose cosmetics.
Taiwan, China
Pre-market Approval
Regulations Governing Notification of Cosmetic Products
Jul 18, 2019
EN
The Regulations stipulate the documents necessary for cosmetics notification, validity for cosmetics notification and other issues related for cosmetics notification in Taiwan.
Taiwan, China
Pre-market Approval
Regulations Governing the Issuance and Management of Cosmetic Certificates
Jul 18, 2019
EN
The regulation specifies the necessary dossiers requirements for 5 types of cosmetic certificates in Taiwan, namely type A cosmetic production and sales certificate, type B cosmetic production and sales certificate, cosmetic manufacturing certificate, imported cosmetic sales certificate and cosmetic good manufacturing certificate.
Taiwan, China
Pre-market Approval
Manufacturer/Importer Regulation
Enforcement Rules of Cosmetic Hygiene and Safety Act
Jul 18, 2019
EN
The Enforcement Rules specify the definition of cosmetic country of origin and manufacturing site and conditions of the claim or advertising violation, etc. and give clear details of the compliance requirements for manufacturer and importer.These Enforcement Rules shall come into force on July 1, 2019, with the exception of Article 3 and Paragraph 2 of Article 4, which shall come into force on July 1, 2021.
Taiwan, China
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Advertising
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