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Jo Zhou
Regulatory Editor & Analyst
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Articles (144)
Taiwan Punished Distributors/Manufacturers of 20 Unqualified Marketed Cosmetics
May 08, 2017
TFDA conducted sample inspections of marketed cosmetics. 20 unregistered medicated cosmetics and 20 imported cosmetics without approval were discovered. Severe punishments were handed out. According to the...
Taiwan, China
Post-market Surveillance
Taiwan Key Inspection Items for Children Cosmetics
May 08, 2017
According to the latest sample inspection on marketed cosmetics, to respond to "Safety Requirements for Children Cosmetics" issued in 2016 (see news on CL), 4 inspection items will be emphasized by TFDA for children cosmetics...
Taiwan, China
Ingredients
Post-market Surveillance
CFDA Appoints Two More Approved Testing Institutions for Cosmetic Registration
May 02, 2017
CFDA appoint "Chongqing Institute for Food and Drug Control" and "Hubei Institute for Drug Control" as approved testing institutions for cosmetic registration. This announcement will be enacted on May 1st 2017. These two institutions will take the responsibility of microbiological test...
Chinese Mainland
Animal Testing
Testing
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
Taiwan Details Restriction on Micro Plastic Beads Used In Cosmetics
Apr 26, 2017
Taiwan FDA decided to ban micro plastic beads used in cosmetics in 2016 (see news on CL) and has now detailed the exact restrictions. Rather than issuing a blanket ban, TFDA has clearly defined...
Taiwan, China
Ingredients
Malaysia Repeals Notification of Cosmetics Containing Hydorquinone, Tretinoin and Mercury
Apr 25, 2017
Malaysia urgently repealed notification of cosmetics products containing Hydorquinone, Tretinoin and Mercury. Retailers or distributors of these cosmetics are subject to fines of up to RM25, 000 or could face imprisonment. As an ASEAN member...
Malaysia
Ingredients
Post-market Surveillance
Taiwan Amends Requirement for Titanium Dioxide in Cosmetics
Apr 20, 2017
Taiwan FDA amended the provision of controlling titanium dioxide in cosmetics last week. Cosmetics which contain titanium dioxide (concentration within 25%, exclude Nano sprayers) are designated as general cosmetics, and...
Taiwan, China
Pre-market Approval
Ingredients
Tips for Cosmetic Enterprises to Fulfill Taiwanese Mandatory Record Filing Obligations
Apr 19, 2017
To record cosmetics online before selling will be mandatory when the new "Statute for Control of Cosmetic Hygiene" is officially published (See news on: CL). Here Chemlinked offers an exclusive Q&A and will offer guidance on the most frequently asked questions. Enterprises will be required to fill out 6 items: products basic information, responsible person, related manufacturer, product package information and record statement...
Taiwan, China
Pre-market Approval
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
Japan Released Amendment of Standard of Quasi Drug Ingredients 2006
Apr 18, 2017
Japan MHLW revised its overall standards for raw ingredients used in quasi drug on Mar 30, 2017. The amendment mainly refers to general testing methods changing of some items and quality standard modification of several ingredients...
Japan
Ingredients
Safety Assessment
Testing
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