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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
Annual Report | A Look Back at 2021 with ChemLinked: Cosmetics Regulation Updates
Jan 20, 2022
2021 was a year of significant events and progress in the cosmetic industry in the Asia-Pacific region. China officially implemented the long-awaited new cosmetic regulation...
Chinese Mainland
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Japan Revises the Approval Requirements for Quasi-drugs
Jul 07, 2021
The drafts of marketing approval standards of medicated oral-care products, hair dyes and permanent wave agents were approved and became effective on July 1, 2021; Enterprises can apply for the manufacture and sale permission of liquid toothpaste to the prefectural government; MHLW revised the list of permitted additives in quasi-drugs.
Japan
Pre-market Approval
Hair Care
Toothpaste
NEWS
[Updated] Japan Approves the Amendments to Good Manufacturing Practice for Quasi-drugs
May 10, 2021
On Nov. 27, 2020, Japan Ministry of Health, Labour and Welfare (MHLW) released the amendments to the Ministerial Ordinance on the Good Manufacturing Practice for Quasi-Drugs and Pharmaceuticals (hereinafter referred to as updated GMP Ministerial Ordinance) for public consultation. Advice and suggestions should be submitted before Dec. 26, 2020.
Japan
GMP
NEWS
Japan Revises the Standards for Marketing Approval of Some Quasi-drugs
Dec 14, 2020
On Dec. 8, 2020, Japan MHLW released three amendments for public consultation, which proposes the modification of the standards for marketing approval of three kinds of quasi-drugs, namely medicated oral-care products, hair coloring agents and permanent wave agents. Any comments shall be submitted before Jan. 6, 2021.
Japan
Ingredients
Efficacy
Toothpaste
NEWS
Japan Updates the Labeling Requirements of High-Concentration Fluoride Toothpaste
Aug 27, 2020
The typography requirements of warning information and the marking method of fluorine concentration were modified for medicated toothpaste with a high fluoride concentration.
Japan
Labeling/Claim/Advertising
Toothpaste
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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
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[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
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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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