Generic Drug Application (ANDA) in China

Generic drugs comprise a significant part of China\’s pharmaceutical market. In 2020, 63% of marketed drugs in China were generics. The Chinese generic drug market size reached 970.7 billion yuan (143.85 billion USD) in 2019 and fell to 808.7 billion yuan1 (circa 119.84 billion USD) in 2020 due to the economic slowdown brought by the COVID-19 pandemic. However, China\’s generic drug market is expected to grow. One reason is that generics usually have lower prices than patented originator drugs, so generics have advantages in volume-based procurement where the price competition is fierce. Another reason is that generics\’ quality has improved remarkably since 2015 as China mandates that generics should be equivalent to originator drug/reference listed drug in quality and therapeutic effects. Furthermore, China encourages the development of clinically-needed and high-quality generics. In the drug patent linkage system, China awards the first generic to successfully challenge the relevant patent drug with 12-month market…

May. 19th, 2022

Generic Drug Application (ANDA) in China

Generic drugs comprise a significant part of China\’s pharmaceutical market. In 2020, 63% of marketed drugs in China were generics. The Chinese generic drug market size reached 970.7 billion yuan (143.85 billion USD) in 2019 and fell to 808.7 billion yuan1 (circa 119.84 billion USD) in 2020 due to the economic slowdown brought by the COVID-19 pandemic. However, China\’s generic drug market is expected to grow. One reason is that generics usually have lower prices than patented originator drugs, so generics have advantages in volume-based procurement where the price competition is fierce. Another reason is that generics\’ quality has improved remarkably since 2015 as China mandates that generics should be equivalent to originator drug/reference listed drug in quality and therapeutic effects. Furthermore, China encourages the development of clinically-needed and high-quality generics. In the drug patent linkage system, China awards the first generic to successfully challenge the relevant patent drug with 12-month market…

May. 19th, 2022

Generic Drug Application (ANDA) in China

Generic drugs comprise a significant part of China\’s pharmaceutical market. In 2020, 63% of marketed drugs in China were generics. The Chinese generic drug market size reached 970.7 billion yuan (143.85 billion USD) in 2019 and fell to 808.7 billion yuan1 (circa 119.84 billion USD) in 2020 due to the economic slowdown brought by the COVID-19 pandemic. However, China\’s generic drug market is expected to grow. One reason is that generics usually have lower prices than patented originator drugs, so generics have advantages in volume-based procurement where the price competition is fierce. Another reason is that generics\’ quality has improved remarkably since 2015 as China mandates that generics should be equivalent to originator drug/reference listed drug in quality and therapeutic effects. Furthermore, China encourages the development of clinically-needed and high-quality generics. In the drug patent linkage system, China awards the first generic to successfully challenge the relevant patent drug with 12-month market…

May. 19th, 2022

Regulatory Compliance Strategy for Cosmetic Ingredients Entering China Market

China is the world\’s largest market and factory for cosmetic products, which makes China the most active country for cosmetic ingredients trading. 2021 witnessed several big changes in cosmetic-related regulations in China. In particular, the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12) became effective from January 1, 2021, and on the same day the overarching cosmetics regulation, the Cosmetic Supervision and Administration Regulation (CSAR) entered into force. This webinar will introduce the compliance strategies for cosmetic ingredients entering China under these two regulations, e.g., new chemical registration, new cosmetic ingredients (NCI) registration and notification, existing ingredient code application on the CFDA portal, etc. Contents Session 1: China\’s Cosmetic Ingredient Compliance under MEE Order No.12 Introduction of MEE Order No.12-China REACH How to Cope with MEE Order No.12 for Cosmetic Industry Common Concerns from Cosmetic Industry Compliance Suggestions from REACH24H FAQs Session 2: China\’s Cosmetic…

May. 09th, 2022

Similarities and Differences Between ASEAN and European Cosmetic Regulations

Background ASEAN or Association of South East Asian Nations is a political, economic and cultural organization operating by consensus among its member states. It includes ten countries of Southeast Asia: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam. In 1998, ASEAN cosmetics regulators and industry representatives established a working group to address issues related to trade barriers for the cosmetics sector. As a result of this collaboration, ASEAN Cosmetic Directive (ACD) has been in force since January 1, 2008, which is based on the former European Union Directive 76/768/EEC and aims to harmonize requirements for cosmetic products. Thus, there are many similarities between the EU Cosmetic Regulation and the ASEAN Cosmetic Directive, among them the definitions of a cosmetic product, the requirements for Product Information File and safety assessment. But there are also differences that should be taken into account before putting cosmetics on the ASEAN…

Apr. 20th, 2022

How to Sell Pet Food to China?

Background Along with the steady national economic growth, urbanization, influence of the one-child policy, low marriage rate and an expanding senescent demographic, keeping pets is trending in China. Up to the end of 2020, China has over 55 million dogs and over 44 million cats in urban area. In this webinar, ChemLinked will share an overview of China’s pet food market, corresponding regulatory requirements, and ways to enter China’s market. Contents 1. An overview of market performance 2. Framework of pet food regulation 3. Product compliance 4. Steps to complete MoARA registration 5. Importation via general trade & CBEC Schedule Date Time (GMT+8) World Clock Language 2022-05-19 16:00 ~ 17:00 UK: 09:00-10:00 English Contact Information If you have any questions about this webinar, please contact us at: EMAIL: contact@chemlinked.com TEL: +86 (0) 571 8609 4444  

Apr. 20th, 2022

How to Sell OTC Drugs to China via Cross-border E-commerce

Background China\’s over-the-counter (OTC) drug market is enormous, with the size of 109.22 billion yuan (circa US$17.13 billion) in 2020. The market keeps gaining momentum due to the aging population and the growing healthcare awareness. The market access regulation on OTC drugs has eased a bit in recent years. In 2019 and 2021, China approved two pilot programs in Beijing and Henan, respectively, for importing over-the-counter (OTC) drugs through cross-border e-commerce (CBEC). Thus, CBEC emerges as a new opportunity for foreign OTC medicines to enter China. This webinar will introduce China\’s OTC drug market and CBEC regulations. We recommend the article for understanding the topic better. For any related questions, please send them to customer@reach24h.com. Contents 1. How China Regulates OTC Drugs 2. An Overview of China\’s OTC Drug Market 3. China\’s CBEC Regulations Import Procedures: (1) Bonded Warehouse; (2) Direct Mail from Overseas Preferential Tax Policy 4. How to Establish…

Apr. 20th, 2022

New Pesticide Registration in China: In-depth Analysis of Challenges and the Trend

New pesticide registration in China is applicable for pesticides containing active ingredients that have not yet been approved for registration in China, including new pesticide TC (TK) and new pesticide formulations. The applicant applying for new pesticide registration shall submit the registration applications for both new pesticide TC and new pesticide formulations, as well as reference samples of the pesticide in accordance with the Administrative Measures for the Registration of Pesticides. Since the implementation of the new Pesticide Registration Data Requirements, pesticide registration has become a risk-oriented pesticide safety assessment mode, with increased test data requirements, extended technical assessment period, high registration costs, and with uncertainty in China. It to some extent inhibits the registration of new pesticides, but pesticide enterprises still have internal motivation for new pesticide registration. The Inevitable Trend of New Pesticide Registration 1. Policy orientation On January 29, 2022, the Ministry of Agriculture and Rural Affairs,…

Apr. 18th, 2022

How to Amend a Registered Pesticide Product under US EPA?

As is well known, the US EPA pesticide registration has always been a difficult task for pesticide enterprises. Enterprises usually have to spend a huge amount of cost to complete a pesticide registration under the US EPA, but subject to registration amendments afterwards due to various reasons, such as trade market demands, formula changes, active ingredient source changes, label changes, etc. What’s the difference between the pesticide registration amendments and new registration? Is the registration amendments easier than new registration? In this article, REACH24H will give a detailed introduction to pesticide registration amendments under the US EPA. What is Pesticide Registration Amendment?  Registration amendments are required when any changes in composition, labeling and packaging of registered pesticide products occur. According to the content of the changes, registration amendments can be categorized into three types: amendment application, notification and non-notification. Registration Amendments Amendment Application Fast-track Amendments Do not require data submission…

Apr. 11th, 2022

Turkey REACH: KKDIK Registration Progress and Strategy

Background The Turkish Authorities (MoEU) published the expected REACH-like regulation (KKDIK) in the official Gazette of the State on 23 June 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. Registration in Turkey REACH is under going and very active. Then the main points of 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 registration and so on.   Contents Review of the regulations for registration of KKDIK The progress and updates of KKDIK Strategies and suggestions for KKDIK Registration in several scenarios Notes on preparing for registration   Schedule Date Time (GMT+8) World Clock Language May 18, 2022 10:00 ~ 11:00 Beijing: 10:00~ 11:00 Chinese May 18, 2022 21:00~ 22:00…

Apr. 11th, 2022
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