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NEWS
Japan Issues Temporary Policy to Speed up the Review Process of Disinfectants
May 21, 2020
Given the increasing applications for approval of disinfectants, MHLW introduced interim guidance on April 24 to accelerate the approval procedures of these newly-designated quasi-drugs...
Japan
Pre-market Approval
NEWS
Japan Puts Eyelash Beauty Liquid New Compliance Requirements
Aug 16, 2019
Market activities involving eyelash beauty liquid (“まつ毛美容液” in Japanese) in Japan will additionally require inclusion of usage precautions and implementation of a monitoring and adverse events reporting system...
Japan
Pre-market Approval
Post-market Surveillance
NEWS
Japan Cosmetic Regulatory Updates: January to July 2019
Aug 01, 2019
Japan made several amendments to its cosmetic’s regulatory framework in the first 7 months of 2019...
Japan
Pre-market Approval
Ingredients
Animal Testing
Safety Assessment
Testing
NEWS
Japan Updates the Positive List of Accredited Foreign Quasi Drug Manufacturers
Jan 04, 2019
On Dec. 12, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued the appended list of “Accredited Foreign Manufacturers”, which is a list of all foreign manufacturers that have been accredited in Japan and includes 264 enterprises for quasi drugs...
Japan
Pre-market Approval
NEWS
Japan Releases Two Instructions on Medicated Soap Market Access Requirements
Apr 09, 2018
Japan MHLW released two instructions for medicated soap market access requirements on Mar 29, 2018. The first instruction regulates the basic requirements for application of medicated soap marketing approval. The second instruction indicates the detailed information on how to fill out the marketing license application form. Requirements for Application for Marketing Approval of Medicated Soaps According to Pharmaceutical and Medical Devices Law, medicated so...
Japan
Pre-market Approval
Ingredients
NEWS
Japan Specifies Quasi Drug Manufacturing and Sale Certificate Application Documentation Requirements
Apr 26, 2017
In Japan, application for a quasi-drug manufacturing and sale certificate (hereinafter referred to as "certificate") requires provision of a product safety report and product efficacy report. Japan MHLW recently specified the requirements related to generation of clinical evaluation data for these reports...
Japan
Pre-market Approval
NEWS
Japan to Adjust Cosmetic/Quasi Drug Manufacture and Sale Licenses Application Requirements
Apr 18, 2017
To align with the revised "Standard for Quasi Drug Ingredient 2006", Japan MHLW will adjust the requirements for cosmetic manufacture and sale license applications. The revision of "Standard" amends 11 testing methods and 10 quality requirements of ingredients...
Japan
Pre-market Approval
NEWS
Japan Publish English Translation of Revised Quality Standard of Permanent Wave Agent
Apr 10, 2017
Japan Ministry of Health, Labor and Welfare (MHLW) published the whole English translation of revised "Standard for Marketing Approval of Permanent Wave Agent" with attached "Qality Standard of Permanent Wave Agent". MHLW amended..
Japan
Pre-market Approval
Ingredients
NEWS
Japan Defines Permanent Wave Agent Marketing Approval
Jan 16, 2017
Japan Ministry of Health, Labor and Welfare (MHLW) is soliciting public consultation on the amendments to "Standards for Marketing Approval of Permanent Wave Agents" until Jan 25 2017. Japan divides the application for marketing approval into two types: integrated application and separated application. The amendments mainly define the applicable scope of the two application types...
Japan
Pre-market Approval
NEWS
Japan Bans 19 Ingredients for Use in Medicated Soaps
Oct 09, 2016
Japanese Ministry of Health, Labour and Welfare (MHLW) announced the ban of 19 kinds of ingredients for use in medicated soaps including medicated hand wash, medicated shower gel and medicated facial cleansing.
Japan
Pre-market Approval
Ingredients
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[Updated] EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics
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[Updated] EU Adopts 11 Changes to the Use Requirements for Cosmetic Ingredients
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China May Provide Six-month Transition Period for Submission of Cosmetic Safety Assessment Report (Full Version)
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Monthly Recap: Global Cosmetic Regulatory Updates | February 2024
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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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