Sept 2022 | China Pharmaceutical Regulatory Updates

This is a collection of China\’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities: National Medical Products Administration (NMPA); NMPA\’s Center for Drug Evaluation (CDE); National Health Commission (NHC); National Healthcare Security Administration (NHSA); National Joint Drug Procurement Office; Chinese Pharmacopoeia (ChP) Commission. For more details about the summarized contents below, please send an enquiry to customer@reach24h.com. Contents China SAMR to Permit Online Sales of Prescription Drugs Nationwide China NMPA Grants One Rx-to-OTC Switch China NMPA Releases 183 RLDs China CFDI Consults on Inspection Guidance for Blood Products China NHSA Announces 343 Drugs Passing the Format Review for NRDL China CDE Releases Pharmaceutical Guidelines Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline 1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide On Sept. 1, 2022, China State Administration for Market Regulation (SAMR) published the Administrative Measures for Supervising Online Sales of Drugs (hereafter…

Oct. 11th, 2022

Regulatory Overview of Food Utensil, Containers and Packaging in Japan

In the past for a long time, the safety of food utensils, containers and packaging (UCP) in Japan was mainly ensured by the Negative List system, which restricts the use of substances with established specifications and standards based on the Food Sanitation Act. In light of the developments and the diversification of food UCP products, as well as global trends, Japan determined to introduce the Positive List system for food UCP in 2018 and unveiled its first Positive List for the synthetic resin of food UCP with effect from June 1, 2020. This webinar aims to interpret the PL system for food UCP in Japan. In this webinar, we will introduce the regulatory framework and related requirements for the UCP, offering a preliminary interpretation of the positive list. Contents Part 1 Regulatory system for food UCP Definition of UCP Relevant regulators and regulations Part 2 Key regulations for food UCP Food Sanitation Act…

Oct. 11th, 2022

CRAC 2022 Virtual Forum: Communicate, Collaborate and Co-Create

As the COVID-19 pandemic is still raging on, the industry landscape has become much more precarious due to protracted uncertainty, risky challenges of emerging virus variants and spillover effects into other risks. More collaboration and communication across society are essential for companies and industries. To build resilience and cooperation, the CRAC 2022 Virtual Forum will help explore the way out in the process of “Communicating, Collaborating & Co-Creating”, to bridge knowledge and communication gaps across regions and share innovative and value-added regulatory, policy and market insights. The CRAC 2022 Forum will focus on the status quo and future challenges and possibilities found in chemical management, pesticide registration, cosmetics, and food contact materials in Asia, the EU, the U.K., the U.S., and other major trade partners. A Collectively Created 2022 Forum In this year of change, CRAC 2022 Virtual Forum aims to serve as an open platform not only for gaining…

Sep. 27th, 2022

IChEMS: New Way in Managing Environmental Chemical Risks in Australia

Background Under the Industrial Chemicals Environment Management (Register) Act 2021, the Industrial Chemicals Environmental Management Standard – IChEMS has been established in Australia. The IChEMS provides a consistent, nationwide approach to managing the risks that industrial chemicals may pose to the environment. Industrial chemicals will be scheduled on the IChEMS register according to their level of concern to the environment, with risk management measures also prescribed. Chemicals will be listed in one of seven schedules according to their environmental risk. On March 23, 2022, a national roadmap to deliver the IChEMS was issued, which sets out key steps, roles and responsibilities in the transition to IChEMS. The authority expects the first scheduling decisions to be made in 2022 H2. The IChEMS Register instrument and a database of publicly accessible chemical scheduling decisions will be available to provide easy access to decisions. In this webinar, Mr. Nick Zovko, Regulatory Policy and Stewardship…

Sep. 26th, 2022

How to Get China\’s Marketing Authorization for OTC Drugs

In China, the marketed drugs have been divided into prescription drugs (Rx drugs) and non-prescription drugs since 2000.Non-prescription drugs, also known as over-the-counter (OTC) drugs, can be bought and used without a prescription from a licensed physician. According to the health information and clinical research service provider IQVIA, China’s OTC drug market size is expected to grow from 244 billion yuan (circa US$35.39 billion) in 2021 to 306.1 billion yuan (circa US$44.4 billion) in 2025, with a compound annual growth rate of 5.3%. To enter such a market via general trade, OTC drugs usually need to go through complicated marketing authorization procedures that may last 2-3 years for drugs exempted from clinical trials, or even 4-5 years for drugs subject to clinical trials. This article discusses how to market OTC drugs in China via marketing authorization application or Rx-to-OTC switch. Contents 1. China\’s Marketing Authorization for OTC Drugs 1.1. NDA &…

Sep. 22nd, 2022

Understanding Cosmetic Regulations in Turkey

Background Turkey holds a position as the bridge between Asia and Europe where there is a high demand for cosmetics. Despite the covid 19, Turkey\’s cosmetic market grows 10% each year. Turkey’s cosmetic supervision is special. It adopts a declaration system for cosmetic products based on the manufacturer’s own statements. It has a different definition of \”manufacturer\” whose scope also includes the \”importer\”. However, still, the cosmetic industry includes particular procedures for certification requirements. In this webinar, ChemLinked invited Ms. Burcu Seven, an attorney from CETİNKAYA. She will give us an overview of cosmetic requirements in Turkey. Contents Cosmetic Market Overview Regulatory Framework Competent Authority Main Regulations Compliance requirements Notification System Product Tracking System («ÜTS») Packaging and Labelling Informing the National Poison Information Center Promotion and Advertisement of Cosmetic Products Audit, inspection, surveillance of Cosmetic Administrative Fines Practicable Advice for Importers (Importing Manufacturers) Schedule Date Time (GMT+8) World Clock Language Speaker…

Sep. 22nd, 2022

How to Succeed in China with KOL Marketing?

Background Online influencers, or key opinion leaders (KOLs), are huge in China, particularly in today’s changing online landscape. Traditional e-commerce platforms like Taobao and JD are becoming increasingly social, such as WeChat and Weibo are more focused on e-commerce, and rising social platforms like RED, Douyin and Bilibili have successfully sped up their pace in advertising and e-commerce. Driven by the wave of social media, KOLs have become ever more noticeable. They become an essential means of brand promotion, a bridge between brands and consumers. In this webinar, Kim Leitzes, Managing Director of Asia Pacific at Launchmetrics, a pioneer in the Chinese Influencer Marketing (KOL) industry, will share her insights into China’s KOL marketing and some takeaways on how brands can leverage KOL marketing. Contents Part 1  Overview of China\’s Social LandscapePart 2  Trends in China KOL MarketingPart 3  Unlocking KOL Analytics:Identifying Winning Strategies with Media Impact ValueTM Part 4  Key Takeaways on How…

Sep. 15th, 2022

Carbon Peaking: China Issues Action Plan for Industrial Carbon Peaking by 2030

China unveiled its carbon peaking plan, highlighting six significant tasks and setting targets for seven key sectors, including steel, building materials, petrochemicals, nonferrous metals, consumer goods, equipment manufacturing and electronics. On August 1, 2022, China’s Ministry of Industry and Information Technology (MIIT), National Development and Reform Commission (NDRC), and Ministry of Ecology and Environment (MEE) jointly released the Carbon Peaking Action Plan for Industrial Sectors, in an effort to shift towards green and low-carbon industry and achieve carbon peaking by 2030. Six Major Tasks 1. Industrial Restructuring It is proposed to readjust the structuring of nonferrous metals, petrochemicals and steel sectors and form industry clustering with low-carbon sectors. The projects with high energy consumption and emissions are expected to be put under tight control. Industries such as steel, cement, flat glass and electrolytic aluminum will implement supply-side structural reform and eliminate excess capacity by means of marketization and legalization. 2. Energy Conservation To further optimize the energy structure, the authorities will…

Sep. 15th, 2022

China’s Beverage Market: Stats and Trends to Watch

Background China’s beverage market has maintained steady growth in recent years. In 2021, the retail sales of Chinese beverages reached 280.8 billion yuan with an increase of 20.4% year on year. The growth has been stimulated by the ongoing consumption upgrade as well as the emergence of new brands such as Genki Forest, Hope Water, etc., and new beverage categories such as sugar-free beverages, and plant-based products.During the webinar, Angelita Hu will give an overview of China’s beverage market from the perspectives of market retail sales, import data, segment performance, consumer analysis, etc., detail the market trends in the industry, and introduce the mandatory market access regulations, helping beverage branding better tap into the market or capture market share. Contents Market Overview Definition and classification Market retail sales Import data Distribution channels Segments performance and top brands Popular products Consumer Analysis Consumer groups Category preference Purchasing factors Trends and Opportunities Segments Products Branding/marketing Market Access Regulation * The final outline may be subject to subtle changes. Schedule Date Time (GMT+8) World Clock Language Speaker 2022-09-22 17:00 ~ 18:00 London: 10:00-11:00 am English Angelita Hu 👉Register now Speaker Angelita Hu ChemLinked Content Manager Angelita Hu is the content manager and regulatory analyst of ChemLinked. She focuses on reporting and interpreting regulatory updates in China, ASEAN and the rest of the Asia Pacific region, promoting and implementing regulatory content innovation and finding global partners to co-build a content ecosystem. With over 7 years of work experience at ChemLinked, she has gained extensive knowledge of cosmetic and food regulations and market entry and an in-depth understanding of the cosmetic and…

Sep. 14th, 2022

China Pharmaceutical Regulatory Updates | August 2022

This is a collection of China’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities: National Medical Products Administration (NMPA); NMPA’s Center for Drug Evaluation (CDE); National Health Commission (NHC); National Healthcare Security Administration (NHSA); National Joint Drug Procurement Office; Chinese Pharmacopoeia (ChP) Commission. Contents China NMPA Grants One Rx-to-OTC Switch China NMPA Publishes the 57th List of RLDs China NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol China NMPA to Adopt ICH E8 (R1) and E14 Guidelines CDE Seeks Public Comments on Pharmaceutical Guideline Drafts China NMPA Grants One Rx-to-OTC Switch On Aug. 26, NMPA granted OTC status to Omeprazole Enteric-coated Tablets, a widely used drug for gastrointestinal diseases. According to Menet Database, Omeprazole\’s sales value in China\’s retail market reached 1.068 billion yuan (circa 155 million USD) in 2020. China NMPA has approved 5,041 OTC drugs, including 1,111 chemical drugs, 3,921 traditional Chinese medicines, and…

Sep. 14th, 2022
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