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South Korea Issues Guidelines for Submitting Reports of Functional Cosmetics Exemption Items

 

The Food and Drug Safety Evaluation Institute (Cosmetics Review Division) has established the “Guidelines for Submitting Reports of Functional Cosmetics Exemption Items” to clearly guide how to prepare and submit reports for functional cosmetics subject to report submission in accordance with Article 10 of the “ Enforcement Rules of the Cosmetics Act” Guide)” has been enacted as attached, so please refer to it for your work.

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Breaking News: China multiple cities ending Zero-COVID Policy

Guangzhou city is the first local government in China to announce that the COVID control policy is ending by sending an obvious signal that officers from the information office of Guangzhou government taking off masks together in the press conference. 

After that, Beijing, Shanghai, Hangzhou, and many more cities declared they will stop social nucleic acid testing and stop checking certificates for nucleic acid.

As the article is publishing, Shanghai and Zhejiang province including 11 cities like Yiwu, Hangzhou, Ningbo etc. have formally announced that: There is no longer a requirement for nucleic acid testing in public areas or on public transportation.

No nucleic acid test certificates will be examined beginning at 0:00 on December 5 when using public transportation in the city, including rail transit, ground buses, and ferries. This also applies to outdoor public spaces including parks and scenic areas. But in order to protect unique populations, unique locations including nursing homes, welfare homes, primary and secondary schools, and kindergartens are still required to do nucleic acid testing.

Most Chinese people won’t need the nucleic acid code SOON!!

It is expected that China’s economic growth will pick up again once the ended Zero-COVID Policy, companies will begin diverse productions in an organized fashion, foreign airlines will open normally, traffic will return to normal, and the true post-epidemic era will soon arrive.

China NMPA issues Cosmetic Products Adverse Reaction Collection and Reporting Principles

In order to implement the “Management Measures for Adverse Reaction Monitoring of Cosmetics“, standardize the collection and reporting of adverse reactions to cosmetics, guide and help cosmetic registrants and filling person to carry out related work on the monitoring of cosmetic adverse reactions, the center of drug evaluation from NMPA researched and drafted the “Cosmetic Products Adverse Reaction Collection and Reporting Principles for Cosmetics registrants and filling person (Draft for Comment)” is now open to the public for comments.

Please send feedback to the email [email protected] before December 9, 2022, and indicate the subject of the email “Cosmetic registrants and filling person Cosmetic Adverse Reaction Collection and Reporting Guiding Principles Opinion”.

 

Cosmetics registrants and filling person

Cosmetic Products Adverse Reaction Collection and Reporting Principles (Trial) (draft for comments)

In order to standardize the collection and reporting of cosmetic adverse reactions, guide cosmetics registrants and filling person (hereinafter referred to as “registrants, filling person”) Carry out work related to the reporting of Cosmetic Production and Operation Supervision and Management Measurescosmetic adverse reactions and formulate this guiding principle in accordance with relevant regulations such as the

This guideline applies to the collection and reporting of cosmetic adverse reactions by registrants and filling person.

 

Registrants and filling person should establish a monitoring and evaluation system for active collection, reporting, analysis and evaluation of cosmetic adverse reactions, and equip institutions and personnel suitable for their products to carry out monitoring of cosmetic adverse reactions in accordance with regulations.

We Moved to a New Domain Name and Here’s Why

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We are excited to inform you that we have been working on an exciting project for some time. We are happy to explain why we are switching to www.cosmetic.news and we are delighted to explain why.

Malicious DDoS Attack 
We ARE NOT exactly sure who is attacking our site constantly. But we indeed found some suspicious attacking IP addresses directly from our competitor’s area.  It raised me to think that our little website must have some deep values that they are afraid of. and we need to amplify our advantages to keep serving our members.

Short and memorable

We decided to modify our domain name to the present one, which is succinct, distinct, and memorable, in an effort to simplify things for you. Members are, after all, our first focus.

Focus on Information
Due to language and cultural barriers, cosmetics brands are constantly misled by false information and fake news, and such will result in the failure of market plans.

We want to maintain a clear focus on cosmetics industry news, regulatory, e-commerce, and business insights.  We thus believe that moving our website from cosmeticsbridge to CosmeticsBridge will aid us in that endeavor.

Please come back often and don’t hesitate to contact us. You may fill out the contact form here. We are always eager to assist.

About CosmeticsBridge.com

We are not abandoning the domain. In the future, we will adopt cosmeticsbridge.com as our consulting service website. As our initial mission is to help clients enter the intended market smoothly.  Consulting service will come next after our clients have a clear view of intended markets with the right information feed. So We truly believe separate our mission into small pieces will help our clients much better.

Shiseido Reveals China Growth Plans

Press conferences for the 150th anniversary of Shiseido Group in China were held concurrently in Shanghai and online on Nov. 15 2022.

China has grown to be the engine of Shiseido Group’s performance development after 41 years in the country, but it is also experiencing growing challenges. How would Shiseido invest in China during the 150th anniversary, a historical turning point? What fresh patterns will emerge in the market the next year?

Shiseido’s president, Masahiko Uotani, said that the company intended to build “the world’s biggest skin care group.” since 2021. Based on that vision, Shiseido China released a number of new development initiatives as part of the new corporate strategy, including innovation and expansion into new markets, brands, and products in China. 

  1. Invest and Innovations 

Shiseido China, the largest international market for the company, now manages 26 skin care brands. In established sectors like anti-aging and sun protection, it already has a robust and well-balanced brand portfolio. It has also extensively deployed in new areas including sensitive skin, green, pure skin care, and males. a brand that may expand.

Shiseido China’s CEO, Kentaro Fujiwara, emphasized that Shiseido is extremely confident about the potential of the Chinese market and would continue to grow investment. Shiseido will continue to make investments in China over the coming years, creating the second-largest R&D facility in the world there. It will also deepen its research on Chinese consumers’ skin, incubate regional innovations like oral and medical beauty, and work with all parties to speed up open source innovation.

  1. Introduce Mature Brands

Shiseido China is implementing multifaceted strategic initiatives in accordance with the “Successful Skin Beauty” plan. To address a variety of demands, the first is to continually release new ones on established, mature brands. A typical example is the luxury beauty personalization brand Infusa from Shiseido. Infusa has dedicated itself to providing customers with “tailor-made” skin beauty solutions ever since its founding in 1986. 

The National Medical Products Administration (NMPA) has agreed to implement the cosmetics customized services pilot program in selected locations by issuing the “Notice on Carrying out the Pilot Program of Cosmetics Personalized Services”. Additionally, this indicates that China firmly supports “customized” cosmetics at the governmental level and encourages them at all levels. To further validate the argument, the previous “Several Regulations on the Innovation and Development of the Cosmetics Industry in Pudong New Area, Shanghai” have also been put into effect.

  1. New Brands and New Niches

Medical Sodium Hyaluronate Management Regulations issued by NMPA China(2022 No. 103)

The index numberFGWJ-2022-256
titleAnnouncement of the NMPA on the management category of medical sodium hyaluronate products (2022 No. 103)
release date2022-11-14

In order to strengthen the supervision and management of medical sodium hyaluronate (sodium hyaluronate) products, further standardize the registration (filing) of related products, and ensure the safety and effectiveness of medical devices used by the public, according to the relevant provisions of the “Drug Administration Law” and “Regulations on the Supervision and Administration of Medical Devices”, The relevant matters related to the management of such products are hereby announced as follows:

  1. According to different intended uses (indications), working principles, etc., medical sodium hyaluronate (sodium hyaluronate) products are managed according to the following situations:

  (1) Products used to treat arthritis, dry eye, etc. shall be managed as drugs.

  (2) If the following conditions are met, and it does not contain pharmaceutical ingredients that exert pharmacological, metabolic or immunological effects, it shall be managed as a medical device, and its management category shall not be lower than the second category.

  1. When used as a contact lens care product, it shall be managed in accordance with Class III medical devices.

  2. When used as an absorbable surgical anti-adhesion material, it shall be managed in accordance with the third category of medical devices.

  3. When it is used as ophthalmic viscoelastic agent, it shall be managed according to the third category of medical devices.

  4. When used as an injection filler to increase tissue volume, it shall be managed according to the third category of medical devices.

  5. As an injection into the dermis, mainly through the moisturizing and hydrating effects of sodium hyaluronate to improve the skin condition, it should be managed as a third-class medical device.

  6. When it is used to repair the glucosamine protective layer of bladder epithelium, it shall be managed according to the third category of medical devices.

  7. When used as a medical dressing, if the product can be partially or fully absorbed by the human body, or used for chronic wounds, it shall be managed according to the third category of medical devices; if the product cannot be absorbed by the human body and is used for non-chronic wounds, it shall be managed according to the second category of medical devices. Device management.

  8. When applied as a scar repair dressing to assist in the improvement of pathological skin scars and to prevent the formation of pathological skin scars, it shall be managed as a second-class medical device.

  9. When used as an auxiliary material for oral ulcer and oral tissue wound healing treatment, it shall be managed as a second-class medical device.

  10. When used as a body cavity device (excluding condoms) to introduce lubricants, it shall be managed as a second-class medical device.

  11. Condoms containing sodium hyaluronate lubricants shall be managed as Class II medical devices.

China Talk 004: All you need to know about China Trademark Registration

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This video talks about tips and will tell you the basic knowledge of #trademark and what kind of trademark categories of #cosmetics should you choose to register.

You must register your trademark in China, even if you do not plan to enter #China now. it’s not a new topic but still, not many people realize it’s important. I have too many cases of that. When our clients are about to enter China, they find that the trademark has already been registered by others.

You have to change the name, the packaging, and the label before exporting to China, which wastes a lot of time and energy. Some customers even need to buy the trademark from the owner at a high price.

Triethanolamine New Exporting Policy issued by China Custom

Triethanolamine is a common ingredient added to cosmetics, and the added concentration is usually low and generally acts as a PH regulator.

According to the catalog for managing import and export licenses for dual-use items and technologies, triethanolamine is a chemical that can be used as a raw material to make chemical weapons. To import or export dual-use items and technologies, you need to apply for an import or export license.

Additional Reading: Cosmetics Raw Material that can be Chemical weaponized: Triethanolamine

The most troublesome thing for enterprises is not only they need to apply for the dual-use phase license of triethanolamine, but also that many enterprises do not have this qualification to apply. It is a chemical that can be used as a raw material for the production of chemical weapons. In order to facilitate national management, it can only be applied by designated enterprises.


So now there is a new regulatory policy on triethanolamine from CosmeticsBridge Insights.

[Full English Version] Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics in China

Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics

(Promulgated by Decree No. 46 of the State Administration for Market Regulation on August 2, 2021, these Provisions shall be effective as of January 1, 2022.)

Chapter I General Provisions

Article 1 These Provisions are formulated in accordance with the Regulations on Supervision and Administration of Cosmetics for the purpose of regulating manufacturing and marketing of cosmetics, strengthening supervision and administration of cosmetics, and ensuring quality and safety of cosmetics.

Article 2 These Provisions shall apply to manufacturing and marketing of cosmetics, supervision and administration in this respect within the territory of the People’s Republic of China.

Article 3 The National Medical Products Administration (NMPA) shall be responsible for supervision and administration of cosmetics nationwide.

The department in charge of drug supervision and administration of local people’s governments at or above the county level shall be responsible for supervision and administration of cosmetics within their administrative areas.

Article 4 The registrant and the filing entity of cosmetics shall establish a quality management system for cosmetics manufacturing according to law, perform obligations related to product including adverse reaction monitoring, risk control, recall etc, and shall be responsible for their quality, safety and efficacy claims of cosmetics. Manufacturers and marketers of cosmetics shall comply with laws, regulations, provisions, mandatory national standards and technical specifications in engaging in manufacturing and marketing activities and conduct vigorous management, maintain integrity and practice self-discipline, thus to ensure the quality and safety of cosmetics.

Article 5 The state exercises licensing management for the manufacturing of cosmetics. To engage in manufacturing of cosmetics, the Cosmetics Manufacturing License shall be obtained in accordance with the law.

Article 6 Manufacturers and marketers of cosmetics shall establish, in accordance with the law, documentation system for the check and test of purchases, and product sales record, and other systems, to ensure traceability of the products.

Manufacturers and marketers of cosmetics are encouraged to adopt information technology to collect and store information on manufacturing and marketing, and establish a traceability system for quality and safety of cosmetics.

Article 7 The NMPA shall enhance informatization construction, to provide convenient services for the public in inquiring information on cosmetics.

The department in charge of drug supervision and administration shall, in accordance with the law, promptly publish regulatory information on cosmetics manufacturing license, supervision and inspection, and administrative penalty, etc.

Article 8 The department in charge of drug supervision and administration shall give full play to the role of the associations of cosmetics industry, the associations of consumers and other consumer organizations, news media, etc., promote the construction of industry integrity system, and advance social co-governance for cosmetics safety.

Chapter II  Manufacturing License

Article 9 Applicants for the cosmetics manufacturing license shall meet the following requirements:

(1) being an enterprise established according to law;

(2) having the manufacturing premises that are appropriate to the varieties, quantity and manufacturing licensed items, etc. of the cosmetics produced, and being kept prescribed distance from toxic and hazardous premises and other sources of pollution;

(3) having the manufacturing facilities and equipment that are appropriate to the varieties, quantity and manufacturing licensed items, etc. of the cosmetics produced, and having a reasonable layout thereof, and the air purification, water treatment facilities and equipment, etc. that meet the specified requirements;

(4) having technicians who are suited to the varieties, quantity and manufacturing licensed items, etc. of the cosmetics manufactured;

(5) having the staff members and equipment that are appropriate to the varieties and quantity of the cosmetics produced and that can perform inspection of the cosmetics produced;

(6) having a management system for guaranteeing the quality and safety of the cosmetics.

Article 10 The applicants for cosmetics manufacturing license shall submit an application to the drug regulatory department of the province, autonomous region or municipality directly under the central government, where it is located, submit the documents proving that they meet the requirements as specified in Article 9 of these Provisions, and shall be accountable for the authenticity of the documents.

Article 11 Regarding the application submitted by applicants for cosmetics manufacturing license, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall handle respectively according to the following circumstances:

(1) If the application items do not require the licensing in accordance with the law, the relevant department shall make a decision of non-acceptance, and issue a notification of non-acceptance;

(2) If the application items are not within the scope of authority of drug regulatory department in accordance with the law, the relevant department shall make a decision of non-acceptance, issue a notification of non-acceptance, and inform the applicant to resubmit the application to the applicable administrative authority;

(3) If the application documents contain errors that can be corrected on site, the applicant shall be allowed to make corrections on site, affix signature or seal to the correction, and indicate the date of correction thereon;

(4) If the application documents are incomplete or do not conform to statutory form, the applicant shall be notified of all contents ought to be supplemented and corrected on site or within 5 working days one-off. If no notification is made within the prescribed time limit, the application shall be deemed to have been accepted upon receipt of the application documents;

(5) The application for cosmetics manufacturing license shall be accepted if the documents are complete and conforming to statutory form, or if the applicant has submitted all the supplementary and corrected documents as required.

For acceptance or non-acceptance of the application for cosmetics manufacturing license, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall issue an acceptance or non-acceptance notice. If non-acceptance is determined, the reason for non-acceptance shall be given, and the applicants shall be informed of being entitled to apply for administrative reconsideration or file an administrative litigation according to law.