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NEWS
CSAR Subsidiary Regulation: China to Implement Administrative Measures on Cosmetics Inspection
Apr 30, 2024
Administrative Measures on Cosmetics Inspection systematically clarifies the requirements about cosmetic inspection categories, inspection procedures, link between inspection and audit, and result handling.
Chinese Mainland
Post-market Surveillance
CSAR
NEWS
China Specifies Practices of Cosmetic Adverse Reaction Monitoring and Reporting
Apr 28, 2024
On November 25, 2022, the Center for Drug Reevaluation and the National Center for Adverse Drug Reaction (ADR) Monitoring of China published the draft of Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial) for public feedback. On April 19, 2024, the finalized version of the Guidelines was released.
Chinese Mainland
Post-market Surveillance
CSAR
Enterprise Obligations
NEWS
Shanghai Government Clarifies Requirements for Cosmetics Advertising: Permissible Efficacy Claims, Content Requirements, and Prohibited Advertising Contents
Mar 14, 2024
The Guidelines provides clear guidelines on the obligations of cosmetic manufacturers and operators as well as necessary documentation for cosmetic advertising. It also specifies permissible efficacy claims, content requirements, and prohibited advertising contents.
Chinese Mainland
Labeling/Claim/Advertising
Post-market Surveillance
Enterprise Obligations
NEWS
MoCRA Updates: U.S. FDA Updates Instructions for Filing out Serious Adverse Event Reports for Cosmetics
Dec 18, 2023
On December 14, 2023, the U.S. Food and Drug Administration (FDA) issued updated instructions for MedWatch Form 3500A, the designated form for reporting serious adverse events pertaining to...
Post-market Surveillance
US
MoCRA
NEWS
First Unannounced Inspection Failure of Foreign Company, Unveiled by China NMPA
Nov 29, 2023
On November 17, 2023, China National Medical Products Administration (NMPA) disclosed that a Japanese cosmetic company failed a recent unannounced inspection organized by the NMPA...
Chinese Mainland
Post-market Surveillance
CSAR
NEWS
CSAR Subsidiary Regulation: China Consults on Administrative Measures on Cosmetics Inspection
Oct 23, 2023
Administrative Measures on Cosmetics Inspection systematically clarifies the requirements about cosmetic inspection categories, inspection procedures, link between inspection and audit, and result handling.
Chinese Mainland
Pre-market Approval
Post-market Surveillance
CSAR
NEWS
Shanghai Government Clarifies Requirements for Cosmetics Advertising: Permitted Efficacy Claims, Content Requirements, and Prohibited Advertising Contents
Oct 13, 2023
The Guidelines provides clear guidelines on the obligations of cosmetic manufacturers and operators and necessary documentation for cosmetic advertising. It also specifies permissible efficacy claims, content requirements, and prohibited advertising contents.
Chinese Mainland
Labeling/Claim/Advertising
Post-market Surveillance
NEWS
[Updated] CSAR Subsidiary Regulations: China Implements the First Regulation on the Supervision for Cosmetic Online Operation
Sep 01, 2023
The Measures clarifies the regulatory objects and authorities of cosmetics online operation, the management responsibilities of cosmetics e-commerce platforms and the obligations of cosmetic operators on the e-commerce platforms.
Chinese Mainland
Post-market Surveillance
CSAR
Enterprise Obligations
NEWS
[Updated] CSAR Subsidiary Regulations: China Implements the Strictest Cosmetic Sampling Testing Regulation
Mar 08, 2023
In September 2020 and June 2022, China National Medical Products Administration (NMPA) issued two drafts of Measures for the Management of Cosmetic Sampling Testing. Finally, on January 12, 2023, NMPA released the finalized Measures, which was implemented on March 1, 2023. The Measures is divided into 8 chapters and 61 articles, providing detailed requirements on the formulation of sampling testing work plan, sampling, testing and result submission, objection and re-testing, verification and disposal of unqualified products, as well as information disclosure. The key points are summarized and analyzed as follows.
Chinese Mainland
Post-market Surveillance
Testing
CSAR
NEWS
Breaking! US Passes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) to Overhaul Cosmetics Regulatory Framework
Jan 09, 2023
On December 29, 2022, US President Joe Biden signed the Consolidated Appropriations Act, 2023 into law, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)...
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Animal Testing
GMP
US
MoCRA
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[Updated] EU Adopts 11 Changes to the Use Requirements for Cosmetic Ingredients
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[Updated] EU Finalizes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics
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China Consults on Guidelines for Submission of Cosmetic Safety Assessment Dossiers: Exemptions for Two Types of Cosmetics from Safety Assessment Report Submission
4
[Updated] Taiwan Amends the List of Prohibited Ingredients in Cosmetics
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[Updated] China Expands Recognized Ingredient Safety Data for Safety Assessment Report
Featured
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Stay Current: China’s Cosmetic Safety Assessment Regulatory Landscape
Under the current regulatory framework, cosmetics registrants and notifiers can continue to submit a simplified version of the safety assessment report during the registration or notification process until May 1, 2025. Following this deadline, a full version of the safety assessment will be mandated. To facilitate a smooth transition, China is planning to release a set of technical guidelines.
China’s Safety and Technical Standards for Cosmetics (STSC) and Its Updates
The current cosmetic technical standard STSC 2015 specifies the cosmetics' general safety standards, prohibited/restricted/permitted ingredients and testing methods. It is revised aperiodically in response to changing trade practices in the industry. China is planning to issue a new version of STSC.
Cannabis Cosmetics Regulatory Updates in the Asia Pacific Region
Cannabis cosmetics are undoubtedly one of the hottest products across the globe in recent years, but with few regulations. To assist cosmetics companies to avoid compliance risks and seize market opportunity, ChemLinked has compiled the regulations.
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