Decoding China\’s Health Insurance & National Reimbursement Drug List (NRDL)

China’s health insurance and National Reimbursement Drug List (NRDL) are significant for innovative drug products to reach the market in hospitals. Reimbursement makes innovative drugs, usually at high prices, to be more affordable to patients. For pharmaceutical companies, earning a place in the NRDL is an approach to widen market access for their drug products. But does NRDL listing a guarantee of sales growth? What is the role of NRDL, a list of drugs adjusted almost annually, in the market dynamics? This webinar organized by ChemLinked BaiPharm Portal is going to answer the questions. Content China’s Health Insurance System 1.1 Social health insurance and commercial health insurance 1.2 How do Chinese citizens get access to healthcare covered/reimbursed drugs 1.3 Reimbursement rate varies in different regions 2. China’s National Reimbursement Drug List (NRDL) 2.1 What is NRDL? 2.2 How does drugs get into NRDL? NHSA selection or negotiation 2.3 Analysis of every round…

May. 12th, 2023

Turkey REACH: Understanding KKDIK Registration & Updates

The Turkish Authorities (MoEU) published the expected REACH-like regulation (Turkey REACH, KKDIK) in the official Gazette of the State on June 23, 2017. There is no requirement for tonnage classification registration in Turkish regulations. All enterprises exporting more than 1 ton/year need to complete registration before December 31, 2023. As the deadline for registration in Turkey is getting closer and closer, this meeting will focus on how to complete the registration in Turkey, enabling enterprises to export to the Turkish market in compliance. Also, this webinar will introduce the current work of formal registration in Turkey REACH, including the requirements and progress of formal registration, strategies, and suggestions on how enterprises should prepare for formal registration, etc. Contents Review of the regulations for registration of KKDIK The progress and updates of KKDIK Strategies and suggestions for KKDIK Registration for lead and joint submissions Notes on preparing for registration Schedule Date…

May. 11th, 2023

The USA New Cosmetic Regulation: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed by the U.S. Congress in December 2022, marks the first significant overhaul of the overarching cosmetic regulation since the enactment of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. This new law introduces several significant changes, including mandatory facility registration and product listing, adverse event reporting, updated labeling requirements, etc. With these changes expected to take effect in December 2023 or the next few years, it is crucial to understand the new cosmetics regulatory framework, compliance requirements, key deadlines, and the latest updates under MoCRA. To that end, Global Regulatory Partners Inc. (GRP), the leading U.S. cosmetics regulatory affairs service provider, has partnered with ChemLinked to host a comprehensive webinar series. During the event, Ms. Mariam Davis, a regulatory affairs professional from GRP, will provide an overview of the cosmetics regulatory landscape in the U.S., highlighting the key updates of MoCRA and…

May. 06th, 2023

Interpretation of Newly Updated Guidance for Taiwan Chemical Registration

Recently, the Toxic and Chemical Substances Bureau (TCSB) under Taiwan EPA officially released the updated Guidance for New and Existing Chemical Substances Phase 1 Registration (hereinafter referred to as the “Guidance”). Its previous version was published in 2015. After several revisions to the Toxic Chemical Substance Control Act (a.k.a. Taiwan TCSCA) and the Regulation on New and Existing Chemical Substances Registration (a.k.a. Taiwan REACH), the content of the 2015 version is no longer suitable as a guidance document for the current regulations. Therefore, the authority revised the Guidance in accordance with current regulations and common issues in recent chemical registrations while referring to chemical regulatory laws in other countries. To help enterprises gain a more accurate and comprehensive understanding of the latest compliance requirements for new and existing chemical substances in Taiwan, as well as future focus, this webinar will provide an in-depth interpretation of the Guidance and share more compliance suggestions. Contents Compliance Interpretation of…

Apr. 24th, 2023

Navigating Philippine FDA Requirements for Food Additives and Importation Permits

The event aims to provide a comprehensive overview of the Philippine Food and Drug Administration (FDA) requirements for food additives and importation permits. The event will be informative and educational, catering to individuals and businesses involved in the food industry, including food manufacturers, importers, distributors, and regulatory professionals. Through a series of presentations, panel discussions, and case studies, the event will cover the latest regulations and guidelines set by the Philippine FDA for food additives and importation permits. Participants will gain insights into the regulatory landscape, understand the requirements and procedures for obtaining permits, and learn best practices for compliance. Content Part 1 Philippine FDA Regulations for Food Additives 1.1 allowable types and levels of food additives 1.2 labeling requirements 1.3 approval process for new food additives Part 2 Importation Permit Requirements 2.1 list of the necessary documents 2.2 procedures and timelines for obtaining importation permits from the Philippine FDA 2.3 common…

Apr. 22nd, 2023

Decoding South Korea’s Cosmetic Labeling Regulation

Cosmetic label is what the consumers note at first when purchasing products which will help them understand what’s in the product and what benefits does it have. Cosmetic labeling compliance is an essential part that cannot be ignored by enterprises targeting the Korean market. Therefore, ChemLinked invited Mr. Mike Sohn, the general manager of REACH24H Korea, to share his insights about labeling regulations in South Korea. He will help you understand the requirements and remove compliance barriers. Content General introduction of cosmetic regulation in South Korea Product classification: General/Functional cosmetics & Quasi-drugs Import process Latest labeling requirements and issues: focusing on efficacy claims and marketing Other regulatory updates Q&A For those who are also interested in understanding cosmetic labeling requirements in Japan (CL webinar on May 31, 2023), ChemLinked prepared a special offer package. Stakeholders can email REACH24H to get access to these two webinars for $159. Schedule Date Time (GMT+8)…

Apr. 19th, 2023

Supervision of GM Foods in Japan

At present, Japan does not commercially cultivate genetically modified (GM) crops. However, it does import GM crops that are resistant to herbicides and pests from the United States and other countries for processing and feed. To ensure the safety of GM foods, the Ministry of Health, Labor and Welfare (MHLW) has made it mandatory under the Food Sanitation Act since 2001 to review their safety before they can be sold in the market. GM foods that have not been confirmed to be safe are prohibited from being sold. This webinar aims to interpret GM foods requirements in Japan. The speaker will introduce the regulatory framework and labeling requirements of GM foods in Japan, and provide guidance on how to pass the MHLW safety inspection and what information is required. In addition, this webinar will address frequently asked questions about GM food. *To have a better chance of your questions being addressed, you’re welcome to email us the questions before the webinar. For those…

Apr. 19th, 2023

Unlock the Chinese Beauty Market – How Can International Beauty Brands Succeed in China?

The Chinese beauty market is a vibrant and rapidly growing, with a massive consumer base that is both savvy and discerning. From traditional herbal remedies to cutting-edge technology, there is something for everyone in this dynamic and exciting marketplace. During the webinar, Moonie Zhu, CEO of eTOC GmbH, will provide a comprehensive overview of the beauty industry in China, including the latest trends, key players, and market size. In addition, she will explore the Chinese beauty consumer, their preferences and behaviors, and the success factors of international beauty brands in China. This webinar presents an excellent chance for both established brands and newcomers to gain valuable insights into how to succeed in the rapidly growing Chinese beauty market, while arming themselves with the essential tools and expertise to excel in this exciting and dynamic industry. Content Overview: The Chinese beauty market Trend Watch: The current trends in the Chinese beauty market…

Apr. 19th, 2023

China MEE Publishes New Chemical Record Registration Statistics in 2022 H2

By a notice issued on April 7, 2023, the Chinese Ministry of Ecology and Environment (MEE) made public 3,069 new chemical record registrations that were received in the second half of 2022, covering more than 21,600 new chemical substances. The attached list contains the applicant and the corresponding representative agent (if any), the time for record registration, the receipt number, and the number of new chemical substances. Details can be accessed here.Under MEE Order No. 12, new chemicals manufactured or imported in quantities below 1 ton per year, polymers containing less than 2% of a new chemical monomer/recant, or PLCs are subject to record registration. Notably, there’s no approval for record registration, which means that businesses can start relevant activities immediately after submitting application materials and receiving the receipt sent via the online registration system. However, in practice, it doesn’t mean that obligations under record registration are that easy to fulfill….

Apr. 14th, 2023

China Cosmetic Ingredient Submission Code Application – Latest Updates and Practical Guidance

The Provisions for Management of Cosmetic Registration and Notification Dossiers that came into force on May 1, 2021 requires cosmetics registrants and notifiers to provide safety-related information about the ingredients used in their products during registration or notification. To simplify the application process, NMPA has introduced the ingredient submission code, which allows registrants or notifiers to fill in the code and directly associate the ingredient safety information, without the need to upload related documents by themselves. However, the regulations surrounding the ingredient submission code have undergone several changes since its introduction. The most recent update to the management measures for the code was released on March 27, 2023. This update clarifies the responsibilities of relevant responsible persons, submission methods for the ingredient submission code, and the transition period policy. To ensure global cosmetics stakeholders stay informed and better understand the latest regulation changes, ChemLinked has invited Ms. Xixi Li, a technical expert from…

Apr. 07th, 2023
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