Understanding Chinese Pharmacopoeia (ChP) 2020

Background The Pharmacopoeia of the People\’s Republic of China (Chinese Pharmacopoeia, or ChP) is China\’s official collection of standards for drug development, production, sales, utilization, supervision, and control. ChP is updated by the Chinese Pharmacopoeia Commission every five years. The latest version is the ChP 2020, of which the API & excipient standards are listed in BaiPharm Database. In China, all drugs shall comply with the ChP standards to obtain marketing authorization. Therefore, ChemLinked BaiPharm Portal holds this webinar to help drug applicants understand and meet the ChP standards.   Contents 1. China National Drug Standard System 2. Content of Chinese Pharmacopoeia (ChP) 20203. How to Get Access to API & Excipient Standards of ChP 2020   Schedule Date Time (GMT +8) World Clock Language 2022-06-15 21:00 ~ 22:00 London: 14:00-15:00 (BST) New York: 9:00-10:00 (EDT) English Speakers Grace Wang ChemLinked Regulatory Analyst Grace Wang is a regulatory analyst and…

Jun. 01st, 2022

Efficacy Claim Evaluation Focus: New Cosmetic Compliance Requirements under China\’s CSAR

Background Before the Cosmetic Supervision and Administration Regulation (CSAR) was released in China, only sunscreen efficacy and the waterproof efficacy of sunscreens were required to be evaluated in accordance with Safety and Technical Standards for Cosmetics 2015. For other efficacies of cosmetics, there is no mandatory requirement, and the testing methods for ready reference are also limited. Under this background, consumers have no access to the supporting materials of cosmetic\’s claimed efficacy, while cosmetic enterprises lack methods to convince consumers.Responding to this situation, in CSAR, NMPA specifies that cosmetic\’s efficacy claims shall be supported by sufficient scientific basis, and requires to publicize the summary of cosmetic efficacy evaluation. Later on April 9, 2021, NMPA issued the finalized Standards for Cosmetic Efficacy Claim Evaluation, rolling out a detailed plan to standardize and guide the evaluation of cosmetic efficacy claims. The implementation of these new requirements reflects China\’s increasingly comprehensive supervision on cosmetics. But at the same…

May. 30th, 2022

China to Renew Medical Sodium Hyaluronate\’s Administrative Classifications

As more sodium hyaluronate products emerge on the market, China is going to update its regulations to better guide the registration and supervision of the products.   On May 20, China National Medical Products Administration (NMPA) released the revised draft of the Announcement on the Administrative Classifications of Sodium Hyaluronate Products for Medical Use (hereafter referred to as the draft and the Announcement, respectively) for public comments. The draft renews the classification system of medical sodium hyaluronate products according to their intended uses and mechanisms of action. RELATED: Interpreting Aesthetic Medicines: Thermage, Hyaluronic Acid and Collagen   Current Classifications of Medical Sodium Hyaluronate The current classifications are based on the 2009 version of the Announcement. Medical sodium hyaluronate products are generally classified into two categories: administered as drugs and as medical devices. Medical Sodium Hyaluronate Classification Products that have clear pharmacological effects, e.g., treating arthritis, dry eyes, skin ulcer, etc. Drug Adjuvant products in eye…

May. 30th, 2022

China to Renew Medical Sodium Hyaluronate\’s Administrative Classifications

On May 20, China National Medical Products Administration (NMPA) released the revised draft of the Announcement on the Administrative Classifications of Sodium Hyaluronate Products for Medical Use (hereafter referred to as the draft and the Announcement, respectively) for public comments. The draft renews the classification system of medical sodium hyaluronate products according to their intended uses and mechanisms of action.1 RELATED: Interpreting Aesthetic Medicines: Thermage, Hyaluronic Acid and Collagen Current Classifications of Medical Sodium Hyaluronate The current classifications are based on the 2009 version of the Announcement. Medical sodium hyaluronate products are generally classified into two categories: administered as drugs and as medical devices.2 Medical Sodium Hyaluronate Classification Products that have clear pharmacological effects, e.g., treating arthritis, dry eyes, skin ulcer, etc. Drug Adjuvant products in eye surgery; Anti-adhesion products in surgery; Tissue filler and tissue volume-augmenting products, etc. Medical Device Classifications for Consultation If following the current classification rules, some sodium hyaluronate products are…

May. 30th, 2022

China Food Import: Procedures and Compliance Tips

Background China is at the forefront of the global importation of food products. According to \”China Imported Food Industry Report 2021\”, China\’s food imports have exceeded 100 billion dollars, and the market is still expanding. The abundant market opportunities have attracted a large number of newcomers. Meanwhile, China is further standardizing its supervision system for imported food. The emergence of updated regulations and new supervisory increased the barriers to market entry. In order to help remove these entry barriers and minimize the risks, ChemLinked combed out key regulatory knowledge and practical tips on food import for international enterprises to avoid common pitfalls and failures.  Contents Part 1  Things You Need to Know 1.1 The Laws You Must Obey 1.2 Who Are the Regulators? 1.3 China Food Import Procedures Part 2  Learn about Food Classification 2.1 China Food Classification Systems 2.2 GB Standard Classification 2.3 HS Code Classification Part 3  Avoid…

May. 30th, 2022

How to Comply with the Cosmetic Regulations in the Middle East

Background The Middle East has long been a relative patchwork of chemical substance regulations, from some countries implementing significant restrictions and requirements on the management of such items to others that appear to employ little-to-no regulation. The landscape for cosmetic products is similarly fragmented, although several countries in the region have taken significant steps to implement regulatory controls on these types of products within their borders. In this webinar, Mr. Michael S. Wenk, President/Director of m4 Global Consulting LLC, will first examine the regulations applicable to cosmetic products across the Gulf Cooperation Council, and then focus on five countries in the region that have well-developed management, labeling, and notification schemes for such products, namely United Arab Emirates, Kuwait, Oman, Bahrain, and Saudi Arabia. Upon completing the webinar, stakeholders will have a much stronger understanding of how such products are regulated and will be able to more confidently approach the Middle…

May. 30th, 2022

Decoding China\’s Drug Marketing Authorization Holder System

In recent years, China\’s pharmaceutical industry has been developing, reforming, and innovating. As a highlight in China\’s Drug Administration Law revised in 2019, the marketing authorization holder (MAH) system impacts the pharmaceutical industry significantly. For overseas pharmaceutical companies interested in the Chinese market, it is helpful to attend the webinar to know the answers to the following questions: How is the MAH system designed in China? What companies can act as MAHs in various scenarios? What are the responsibilities and obligations of MAHs in China? How to choose an MAH when an overseas drug is ready to enter the Chinese market? In this webinar, Joy Chen, BaiPharm Business Development Manager, will answer the questions and talk about the requirements of the new MAH system in China, the way to control the change of MAHs under different circumstances, and the future trends and advantages of the Chinese MAH system based on its development history. RELATED…

May. 20th, 2022

Decoding China\’s Drug Marketing Authorization Holder System

In recent years, China\’s pharmaceutical industry has been developing, reforming, and innovating. As a highlight in China\’s Drug Administration Law revised in 2019, the marketing authorization holder (MAH) system impacts the pharmaceutical industry significantly. For overseas pharmaceutical companies interested in the Chinese market, it is helpful to attend the webinar to know the answers to the following questions: How is the MAH system designed in China? What companies can act as MAHs in various scenarios? What are the responsibilities and obligations of MAHs in China? How to choose an MAH when an overseas drug is ready to enter the Chinese market? In this webinar, Joy Chen, BaiPharm Business Development Manager, will answer the questions and talk about the requirements of the new MAH system in China, the way to control the change of MAHs under different circumstances, and the future trends and advantages of the Chinese MAH system based on its development history. RELATED…

May. 20th, 2022

China Encourages Innovative Drug R&D in Draft of Regulations for Implementing DAL, 2022

On May 9, China National Medical Products Administration (NMPA) released the draft of the revised Regulations for Implementation of the Drug Administration Law (hereafter referred to as the Regulations) for public comment. The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Compared to the 2016 revised version, the draft of the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019. The new contents involve a marketing authorization holder system, patent protection, and pharmacovigilance, whose regulations just came out in the past few years. (Pharmaceutical Application Services) RELATED: China\’s Marketing Authorization Holder (MAH) System; China\’s Drug Patent Linkage System; China\’s Good Pharmacovigilance Practices. Regulation Contents Contents of the Regulations for Implementation of the Drug Administration Law 2016 Revised Version1  Revised Draft of the 2022 Version for   Consultation2 Ÿ   Chapter I: General Provisions Ÿ   Chapter II: Administration of…

May. 20th, 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
  • 문의하기
  • +82-02-6245-1610
  • korea@reach24h.com

TSCA Inventory Search Tool