November 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 1. China NMPA Renews Classifications of Sodium Hyaluronate Products 2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks 3. China NMPA Consults on Chemical API Registration Renewal Regulation 4. China NMPA Announces Drug Banned from Online Sales 5. China NMPA Requires Online Drug Sellers and E-commerce Platforms to File Information 6. China NMPA to Enforce Drug Retail Delivery Regulations 7. China NMPA Consults on Drug MAH’s Main Responsibilities 8. China CDE Implements Work Procedures for Changes During Drug Review 9. China CDE Implements…

Dec. 14th, 2022

(K-BPR) Chemical Safety Concerns in Consumer Products – Exposure and Health Risk

REACH24H hosts its 14th Chemical Regulatory Annual Conference, free for all attendees to participate. Building on the success of the past two years of virtual forums, CRAC 2022 this year 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. CRAC 2022 – Global Chemical Compliance Management Session In response to the rising concerns over chemical products after the “toxic humidifier sterilizer” accident in 2011, South Korea has accelerated the legislative process regarding chemical products.  Since the enactment of the “Consumer Chemical Products and Biocides Safety Control Act” (i.e., “Chemical Product Safety Act”) in 2018, any manufacturer, importer, seller, and distributor of active substances and biocidal products shall receive approval from the Ministry of Environment(MOE). To help simplify the K-BPR compliance, we have invited Dr. Jaewoong Lee, Government Research Officer of the National Institute of Environmental…

Dec. 13th, 2022

Overview and Comparison of EU and US Cosmetic Regulations

When it comes to cosmetic product regulation, the European Union and the United States of America have very different standards. Yet, these two markets are very attractive and represent nearly 50% of the value of the global cosmetics industry. To help companies interested in going to Europe or looking to expand to the US understand EU and US cosmetic regulatory framework, EcoMundo, a company with over 15 years of experience in navigating through regulations in the US and EU, has teamed up with ChemLinked to host this webinar. During the webinar, regulatory experts from EcoMundo will describe the regulations in place in these two different regulatory areas and will identify the similarities and differences between the two. They will also provide precious information and tips to help companies reach regulatory compliance in the targeted destinations. Notes: Please feel free to send us questions before, during or after the webinar; The presentation deck…

Dec. 07th, 2022

Analysis of EU CLP Compliance and Progress Update | CRAC 2022

REACH24H hosts its 14th Chemical Regulatory Annual Conference, free for all attendees to participate. Building on the success of the past two years of virtual forums, CRAC 2022 this year 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. CRAC 2022 – Global Chemical Compliance Management Session The CLP Regulation is Regulation (EC) No 1272/2008 on the Classification, Labelling, and Packaging of substances and mixtures. The legislation introduces throughout the EU a new system for classifying and labelling chemicals, based on the United Nations’ Globally Harmonised System or ‘GHS’. Annex VIII was adopted and was added to CLP Regulation (EC) No 1272/2008 on 22 March 2017, harmonising the information to be provided relating to emergency health response. The regulation describes the information of hazardous mixtures that are put on the EU market and have physical…

Dec. 06th, 2022

EU REACH Compliance Requirements and Future Update Plans | CRAC 2022

REACH24H hosts its 14th Chemical Regulatory Annual Conference, free for all attendees to participate. Building on the success of the past two years of virtual forums, CRAC 2022 this year 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. CRAC 2022 – Global Chemical Compliance Management Session The European Union’s REACH Regulation (Registration, Evaluation and Authorization of Chemical Substances – EC1907/2006, EU REACH) is mandatory for the continued sale of chemicals and products into the European Union, which is managed and enforced by the European Chemicals Agency (ECHA). In recent years, we have witnessed some significant regulatory changes and updates of EU REACH, which makes compliance somehow confusing and difficult for a lot of companies. To help simplify the REACH compliance, we have invited Catherine Cornu, Senior Scientific Officer of ECHA, to introduce the updated…

Dec. 02nd, 2022

Practical Experience of Customs Clearance for Food and Cosmetic Products to China

According to the State Council Information Office of China (SCIO), China\’s imports via general trade grew by 6.5% to 5.55 trillion yuan in the first half of 2022, which showcased that an increasing number of foreign products are entering the Chinese market. As we know, China is at the forefront of the world\’s food and cosmetics imports. However, products are subject to stringent supervision in China and must undergo a series of inspections for customs clearance. In this webinar, the speaker will introduce the regulatory requirements of food and cosmetic products. After that, she will focus on customs clearance, including the steps, commonplace mistakes and tips to mitigate the potential risks. Content Part 1 Preparations for market access 1.1 Entry conditions for cosmetics and food goods via general trade 1.2 Qualification preparation for customs clearance Part 2 Procedures and required documents for customs clearance 2.1 Flow chart of import customs…

Nov. 30th, 2022

Comparison between EU and China Cosmetic Regulatory Framework

Since 2021, China National Medical Products Administration (NMPA) released and implemented the Cosmetic Supervision and Administration Regulation and a series of subsidiary regulations, reconstructing the entire cosmetics regulatory system. The regulatory focus of NMPA is gradually shifting from the previous emphasis on pre-market approval to the combination of pre-market approval and post-market surveillance. China\’s brand-new regulatory system has similarities and differences with the EU\’s. For European companies or companies already marketing cosmetics in Europe, what differences should be considered before placing cosmetics on the Chinese market? In this webinar, Hedy He from ChemLinked will detail the similarities and differences in basic regulatory information, pre-market requirements, post-market surveillance, company responsibility, etc. Notes: Please feel free to send us questions before the webinar; The presentation deck and recording video will be uploaded to this webpage after the webinar; If you can\’t attend the live webinar, register anyway and we will send you the webinar…

Nov. 29th, 2022

Understanding the Requirements of Food Additives in Indonesia

Since food additives are consumed through processed foods, food additives are strictly supervised and required to undergo various safety tests before being placed on the market in many countries. In Indonesia, the Food and Drugs Authority, which is knowns as Badan Pengawas Obat dan Makanan or BPOM, regulates food additives through a well-established safety management mechanism, which required a certain set of complex regulations. These barriers, including language, make it difficult for many foreign companies to learn compliance requirements and enter the Indonesian market. To help overseas enterprises better understand Indonesia\’s food additive requirements, Tassa Agustriana, a founder of Thrive Food Consulting, an Indonesian-based independent consulting service, that also covers Scientific Regulatory Affairs and Compliance, will provide a comprehensive understanding of Indonesia\’s food additive regulations, including the definition and classification of food additives, approval, and registration of new food additives for trading and distribution purpose, and the most up-to-date regulation. Content…

Nov. 28th, 2022

Introduction to Taiwan Chemical Substance Registration Regulation

Since Taiwan EPA issued the Regulation of New and Existing Chemical Substances Registration, it has attracted a lot of attention. This year, China\’s Taiwan region has made amendments to the New and Existing Chemical Registration Regulation and extended the registration deadline for 106 PECs. In this webinar, we will focus on the introduction to the latest existing and new chemical registration regulation, including registration types, data requirements, post-registration obligations, and compliance advice for companies, in an effort to help companies keep abreast of regulatory developments and avoid trade disruptions. Content Framework of Taiwan Chemical Substance Registration Regulation Existing and New Chemical Substance Registration Regulation Post-Registration Obligation Advice from REACH24H Schedule Date Time (GMT+8) World Clock Language Speakers 2023-01-10 21:00 ~ 22:00 London: 13:00-14:00 New York: 08:00-9:00 English Jessica Zhang 👉Register now Speakers Jessica Zhang Regulatory Affairs Consultant, REACH24H Consulting Group Ms. Jessica Zhang is an experienced consultant specializing in chemical…

Nov. 28th, 2022

ANDA, NDA, BLA Registration and Registration Renewal in China

ANDA: abbreviated new drug application; NDA: new drug application; BLA: biologics license application Legal Basis of ANDA, NDA, BLA Registration and Registration Renewal Drug Administration Law of the People\’s Republic of China (2019 Revision); Regulations for the Implementation of the Drug Administration Law of the People\’s Republic of China (2019 Amendment); Measures for the Administration of Drug Registration (2020 Revision) ANDA: Application for Market Approval of Generic Drugs Product Scope ANDA: generic drugs which are imported, sold, and used within the territory of the People’s Republic of China. Eligibility of Applicants Domestic applicants shall be an enterprise or drug development institution that can assume corresponding legal responsibilities. Overseas applicants shall be overseas pharmaceutical manufacturers with legal drug market approval. For overseas applicants, they must entrust a China business entity as the local agency. Application Procedure Domestic generic drugs, imported generic drugs Post-Marketing Obligation Change management, including major, medium, and minor-level…

Nov. 28th, 2022
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