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NEWS
Taiwan to Update the Applicable Products for GMP Requirements
May 13, 2024
On May 10, 2024, TFDA released the draft of Cosmetic Categories for Which Manufacturing Premises Shall Comply with Cosmetics Good Manufacturing Practice Regulations, aiming to replace the existing regulation titled Cosmetic Categories That Shall Comply with Cosmetics Good Manufacturing Practice Regulations. In line with the discontinuation of the specific purpose cosmetics category from July 1, 2024, the draft revises the expressions used in the regulation, and clarifies its applicable scope.
Taiwan, China
GMP
NEWS
South Korea Publishes CGMP Guidelines to Support Korean Cosmetic Industry
Apr 24, 2024
MFDS published CGMP guidelines to help enterprises smoothly pass the evaluation.
South Korea
GMP
NEWS
Vietnam Plans for Substantial Revision of Cosmetics Overarching Regulation
Dec 22, 2023
On December 13, 2023, the Vietnam Ministry of Health (MoH) announced the proposed development of a new Decree on cosmetics management. It has already submitted relevant documents to the Government, requesting consideration, comments, and approval for the proposal.
Vietnam
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
GMP
NEWS
Japan Updates the GMP Compliance Inspection FAQs
Sep 04, 2023
On August 18, 2023, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) updated the frequently asked questions (FAQs) for compliance inspection of Good Manufacturing Practice (GMP). As revealed by the GMP Ministerial Ordinance, wWhen manufacturing quasi-drugs designated by the Minister of Health, Labour and Welfare (MHLW), the product shall comply with GMP through manufacturing control and quality management. Besides, an application for GMP compliance inspection is necessary.
Japan
GMP
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
NEWS
CSAR Subsidiary Regulations: China Finalizes Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices
Nov 05, 2022
On October 25, 2022, NMPA released the finalized Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices, which will take effect on December 1, 2022. Compared to the previous draft, the finalized Points adopts minor amendments.
Chinese Mainland
GMP
CSAR
Enterprise Obligations
NEWS
Indonesia Consults on the Draft Regulation for Perfume Refill
Sep 22, 2022
This regulation stipulates the requirements for perfume refill, including factory design, manufacturing facility, ingredients, packaging materials, environmental sanitation, storage conditions, document, labeling, supervision and inspection, as well as non-compliance penalties.
Indonesia
Ingredients
Labeling/Claim/Advertising
GMP
NEWS
Malaysia Amends Guidelines for Control of Cosmetic Products
Jul 26, 2022
The main amendments are 1) Adding product examples classified as cosmetics and not classified as cosmetics, requirements for product complaints, as well as 3 guidance for hand sanitizers, antibacterial hygiene products, and product reporting and recall; 2) Revising and clarifying requirements for cosmetic notification, GMP inspection, GMP certificate, as well as cosmetic naming, labeling, claiming, and advertising.
Malaysia
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
GMP
NEWS
[Updated] CSAR Subsidiary Regulations: China Implements the Finalized Good Manufacturing Practices for Cosmetics
Jul 01, 2022
The Practices finalizes the qualification requirements and duties of the person in charge of quality and safety, ensures the traceability of products from production to market, refines the requirements for sample retention, further clarifies the requirements for entrusted production, etc.
Chinese Mainland
GMP
CSAR
Enterprise Obligations
NEWS
CSAR Subsidiary Regulations: China NMPA Consults on the Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices
Apr 01, 2022
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.
Chinese Mainland
GMP
CSAR
Enterprise Obligations
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[Updated] EU Adopts 11 Changes to the Use Requirements for Cosmetic Ingredients
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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
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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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