\’No-Data\’ Registration under UK REACH

Background UK REACH came into force on 1st January 2021. Companies who place chemicals on the market in England, Wales or Scotland have obligations under UK REACH. In regard to the second year of UK REACH, as transitional provisions such as DUIN and \’Grandfathering\’ are drawing to a close, we shall pay more attention to the registration and data sharing, which is a great challenge and the most pressing issue for stakeholders under UK REACH. If you are still hesitating over the compliance strategy and concerning about the data cost, our \’No-Data\’ registration solution may answer your perplexity. In this webinar, we will navigate the process of UK REACH compliance, emphasizing on how to complete a \’No-Data\’ registration quickly, to help the companies seize the opportunity of UK market access. Contents UK and EU: similar but parallel regulatory frameworks The advantage of ‘No-Data’ registration Further steps: data-sharing models Q&A Schedule…

Mar. 21st, 2022

The Latest Regulatory Updates on and Trends of China’s Health Food

Background In recent years, the filing scope of health food has been expanding. Last year, several important regulations related to health food were updated or newly issued. In this webinar, ChemLinked will focus on: The scope of health food and how it relates to overseas dietary supplement General requirements on health food, the latest updates, and trends Ways to get product into China (Mergers and acquisitions/CBEC/Filing/Imported as common food) Contents 1. The scope of health food and how it relates to overseas dietary supplement Health food’s definition Health food’s relation with dietary supplement 2. General requirements on health food, the latest updates, and trends Major requirements The latest updates Trends 3. Ways to get product into China Mergers and acquisitions CBEC Filing Imported as common food Schedule  Date Time (GMT+8) World Clock Language  2022-04-13 16:00 ~ 17:00 UK: 09:00-10:00 English Speakers Yuanzhao Yu-Food regulatory specialist Yuanzhao Yu, graduated from North Carolina State University with a master\’s degree in food…

Mar. 18th, 2022

A Tutorial Guide & FAQ for GACC Overseas Food Manufacturer Registration

Background On Apr. 13, 2021, General Administration of Customs of China (GACC) issued the new version of “Administrative Provisions on Registration of Overseas Manufacturers of Imported Foods (Decree 248)”, which will come into effect on Jan. 1, 2022. It stipulates that all food categories (excluding food additives and food-related products) shall be subject to overseas manufacturer registration. In November 2021, ChemLinked delivered a webinar on the fundamental requirements of GACC food manufacturer registration and gave an overall introduction to the corresponding registration system. Three months after the implementation of Decree 248, there are still some manufacturers who haven\’t got the Chinese registration number. In this webinar, ChemLinked will help stakeholders understand how to fill in the information of each blank during the registration, explain the updates & changes of the registration system and share with the audience the most common aspects that lead to registration and import rejection. Contents Part 1. A…

Mar. 18th, 2022

Intermediates Registration under MEE Order No.12: Introduction and Case Sharing

Background The intermediate, which plays a key role in the global chemical industry, is treated and regulated variously by countries and regions. Although the risks of intermediate are manageable compared with other chemicals, it is necessary to control and monitor the risk of exposure to human health and the environment. MEE Order No.12 significantly decreases the data requirements for intermediates, thereby releasing the burden of companies. However, in practice, there are still some difficulties in intermediates registration. With the implementation of MEE Order No.12 for over 1 year, REACH24H schedules a webinar with a special focus on intermediates registration under this measure. Contents Background Information on MEE Order No.12 Definition of Intermediate and Examples Registration Requirements for Intermediates Registration Period and Cost for Intermediates Potential Issues of Intermediates Registration Schedule Date Time (GMT+8) World Clock Language 2022-03-22 10:00 ~ 11:00 Beijing: 10:00-11:00 Chinese 2022-03-22 21:00 ~ 22:00 London: 13:00-14:00 New…

Mar. 01st, 2022

Intermediates Registration under MEE Order No.12: Introduction and Case Sharing

Background The intermediate, which plays a key role in the global chemical industry, is treated and regulated variously by countries and regions. Although the risks of intermediate are manageable compared with other chemicals, it is necessary to control and monitor the risk of exposure to human health and the environment. MEE Order No.12 significantly decreases the data requirements for intermediates, thereby releasing the burden of companies. However, in practice, there are still some difficulties in intermediates registration. With the implementation of MEE Order No.12 for over 1 year, REACH24H schedules a webinar with a special focus on intermediates registration under this measure. Contents Background Information on MEE Order No.12 Definition of Intermediate and Examples Registration Requirements for Intermediates Registration Period and Cost for Intermediates Potential Issues of Intermediates Registration Schedule Date Time (GMT+8) World Clock Language 2022-03-22 10:00 ~ 11:00 Beijing: 10:00-11:00 Chinese 2022-03-22 21:00 ~ 22:00 London: 13:00-14:00 New…

Mar. 01st, 2022

Hazardous Chemical Registration System Upgrade and \”One Enterprise, One Chemical Product, and One QR Code\” Application

Background In order to strengthen the safety management of hazardous chemicals and prevent and reduce hazardous chemical accidents, on January 5, 2022, the Work Safety Committee of the State Council issued a notice (Safety Committee [2021] No. 12) on the National Program for Centralized Management of Safety Risks of Hazardous Chemicals. The program proposes to improve the digital and intelligent management and control of dangerous chemical safety risks. The Ministry of Emergency Management is responsible for promoting the upgrading of the chemical registration system, adding the function for the standardization of SDS and labeling, expanding the scope of registration of chemical and pharmaceutical enterprises, implementing \”one enterprise, one chemical product, and one QR code\” management for each hazardous chemicals of enterprises, and providing basic support for the efficient hazard information transfer and the the whole life cycle supervision of hazardous chemicals. The new hazardous chemical registration system was officially launched…

Feb. 24th, 2022

Hazardous Chemical Registration System Upgrade and \”One Enterprise, One Chemical Product, and One QR Code\” Application

Background In order to strengthen the safety management of hazardous chemicals and prevent and reduce hazardous chemical accidents, on January 5, 2022, the Work Safety Committee of the State Council issued a notice (Safety Committee [2021] No. 12) on the National Program for Centralized Management of Safety Risks of Hazardous Chemicals. The program proposes to improve the digital and intelligent management and control of dangerous chemical safety risks. The Ministry of Emergency Management is responsible for promoting the upgrading of the chemical registration system, adding the function for the standardization of SDS and labeling, expanding the scope of registration of chemical and pharmaceutical enterprises, implementing \”one enterprise, one chemical product, and one QR code\” management for each hazardous chemicals of enterprises, and providing basic support for the efficient hazard information transfer and the the whole life cycle supervision of hazardous chemicals. The new hazardous chemical registration system was officially launched…

Feb. 24th, 2022

Understanding Cosmetic Regulations in the United States

Background In the US, the Food and Drug Administration (FDA) does not require pre-approval of cosmetic products and ingredients (with the exception of color additives) prior to being placed on the market. This is often misunderstood to mean that cosmetics aren’t regulated in the US. Although the FDA doesn’t require pre-approval of cosmetics, there are very specific requirements prohibiting the adulteration or misbranding of cosmetics, which ensures the products being offered for sale do not pose risk of harm to users under normal conditions of use. In this webinar, Dr. Shannon Gainey, the Technical and Regulatory Director from REACH24H USA, will provide an overview of the US regulatory framework for cosmetics according to the Food and Drug Administration, specific requirements for ingredients and the label, how products that are both a cosmetic and drug are regulated as well as some of the regulatory requirements that are specific to several states…

Feb. 21st, 2022

Drug Application Fees for FY 2022 in China and the U.S.

In general, drug regulators charge fees from applicants to ensure the review of drug applications proceed efficiently. For drug applicants, the fees are legally bounded for acquiring or extending marketing authorization. This article introduces drug application fees in China and the United States (U.S.), the top two largest markets targeted by pharmaceutical companies. China National Medical Products Administration (NMPA) has been implementing its latest version of drug registration fee standards since July 1, 2020. The standards are expected to remain in effect till its next version comes out. The fees are mainly charged for drug applications. The U.S. Food and Drug Administration (FDA) updates its drug user fees every fiscal year (FY) which starts from Oct. 1 of last year and ends on Sept. 30 (e.g., FY 2022 is Oct. 1, 2021-Sept. 30, 2022). The drug user fees, which are collected from pharmaceutical industry stakeholders, are levied on applications, programs,…

Feb. 16th, 2022

Biogen\’s Rare Disease Drug Gets Access to More Patients in China Due to NRDL

In December 2021, Biogen cut the price of Spinraza (Nusinersen Sodium Injection) from 700,000 yuan per dose to 33,000 yuan per dose. The move was for getting a place in China\’s National Reimbursement Drug List (NRDL). Thanks to the price cut, nearly 30 patients1 across China got administered with Spinraza on Jan. 1, the first day of the new NRDL took effect. Spinraza Entered the Chinese SMA Treatment Market Via Priority Review SMA, a rare disease characterized by muscle atrophy or weakness, currently affects 30,000-50,000 patients in China.2 The disease\’s incidence is 1/10,000-1/6,000 among infants. According to estimation, about 1,023 to 1,705 among the average 10,232,667 newborn babies4 in China during the past three years suffer from SMA. Biogen became the first SMA therapy approved by China National Medical Administration on Feb. 25, 2019, about two years after the approval by the U.S. Food and Drug Administration on Dec. 23, 2016.5. Given Spinraza\’s…

Feb. 16th, 2022
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