October 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 Issues New Administrative Measures for Drug Recall 2. China NMPA Temporarily Extends Deadlines for Submitting Supplemental Documents 3. China NMPA Consults on GLP Certification Regulation 4. China NMPA Releases the 61th List of RLDs 5. China NMPA to Issue Electronic Certificates and Approval Documents 6. CDE Issues a Series of Guidelines and Rules 7. ChP Commission Seeks Public Advice on Drug Standards 1. China NMPA Issues New Administrative Measures for Drug Recall On Oct. 26, China NMPA issued the New Administrative Measures for Drug Recall, which took…

Nov. 09th, 2022

How to Comply with Cosmetics Advertising Regulations in Japan

After years of development, the target group of Japanese cosmetics has expanded from young people to the elderly to children, and the level of consumers has continued to improve. But the advertising problems that came with it, such as exaggerated or false claims, have also been exacerbated. Such illegal acts not only undermine consumer trust and reduce sales, but also face severe penalties from the government, which imposes a fine equivalent to 4.5% of sales on illegal products based on its administrative discretion. Therefore, complying with the laws and regulations related to cosmetics advertising in Japan, such as the Pharmaceutical and Medical Devices Law, and the Guidelines for Cosmetic Advertisements 2020 formulated by the Japan Cosmetics Industry Association, etc. is of significant importance for companies to conduct cosmetics business in Japan. This webinar will introduce the current advertising regulations, supervision, essential advertising claim requirements, etc. and analyze some advertising cases, offering a preliminary overview for stakeholders that want to…

Nov. 07th, 2022

Regulatory Compliance of Food Labels in the United States

Background According to the FDA, more than 10,000 registered food facilities in China export to the United States. Chinese Entrepreneurs have a major opportunity to gain exposure and knowledge about the US market and regulations. The FDA has basic labelling requirements and other regulations. The webinar will focus on several topics around Labels and information that will be required to meet regulatory compliance. Contents Introduction Topic 1: Food Labeling Government Agencies Topic 2: Labeling Requirements Topic 3: Ingredient and Allergens Declaration Topic 4: Food Labeling Claims Topic 5: Nutrition Labeling Summary Notes:  Please feel free to send us questions before, during and/or after this webinar. The presentation deck, recording video and QA document will be uploaded to this web page after this webinar. Schedule Date Time (GMT+8) World Clock Language 2022-11-22 16:00 ~ 17:00 London: 08:00-09:00 English 👉Register now Speaker Napoleon Poulos Managing Director Napoleon is the Managing Director of…

Nov. 02nd, 2022

Cross-Border E-Commerce for OTC Drug

E-commerce market in China has become one of the most developed ones in the world, accordingly, the competition is fierce. Well-functioning ecosystem of online payment options and powerful mobile segment has made this market one of the important components of Chinese economy overall. As market trends are always changing, it is vital to take proper methods to create your competitive advantages and educate the consumers, thus generate ideal sale. BaiPharm has established our own online stores on Tmall Global and JD Worldwide, which are licensed to sell overseas OTC drugs to individual Chinese consumers. We would be delighted to try new and vigorous brands and products. Also, we can help overseas brands set up their own online stores in Tmall, JD, Tik Tok, and serve as a local agency for running the online business. Besides, we are open to supporting clients’ digital marketing campaigns. Our Services Local Agency Services Select…

Oct. 31st, 2022

China to Issue Electronic Drug Registration Certificates from November 2022

From Nov. 1, 2022, China National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as legally valid as the paper version. Electronic drug registration certificates will cover: Clinical trial approval certificate Marketing authorization certificate Re-registration certificate (for registration renewal) Supplemental application approval certificate Traditional Chinese medicine (TCM) protection certificate Imported raw ingredient certificate Certificate for active pharmaceutical ingredient (API) of chemical drug Good laboratory practice (GLP) certificate Marketing authorization holders (MAH) and drug applicants should sign up at NMPA\’s online service platform and confirm their real names, then check and download the electronic drug registration certificates. They can also log in to NMPA\’s mobile app \”中国药监\” to check the electronic certificates. Documents such as drug manufacturing process document, quality standard document, medication package insert, and label will not be included in electronic drug registration certificate itself. Instead, along with the electronic certificates, the attachments will be available in…

Oct. 31st, 2022

OTC Drug Focus: How to Start and Manage Your Cross-border E-commerce (CBEC) Operations in China

Background According to Statista, China has already surpassed the US and become the largest OTC pharmaceutical market in the world. The OTC drug revenue in China is expected to be the US $27.28bn in 2022. 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 if exempted from clinical trials, or even 4-5 years if subject to clinical trials. China has issued pilot policies that support the import of OTC drugs via cross-border e-commerce (CBEC). In December 2019, China\’s National Medical Products Administration (NMPA) permitted Beijing to import OTC pharmaceutical products through CBEC. In May 2021, another CBEC pilot program was approved by the State Council for importing drugs to Henan Province. Thus, cross-border e-commerce is developing as a promising approach to China\’s OTC pharmaceutical market. In Statista\’s estimation, 57.9% of total revenue will be generated…

Oct. 17th, 2022

OTC Drug Focus: China Market Overview and CBEC Channel Analysis

In China, OTC drugs mainly refer to cold drugs, cough drugs, pain relievers, gastrointestinal prokinetic drugs, gastric antacids, vitamins, anthelmintics, tonics, constipation drugs, drugs for external use, contraceptives, skin care drugs, etc. According to IQVIA, China’s OTC drug market has been keeping steady growth. The market sales are expected to increase from 244 billion yuan in 2021 to 306.1 billion yuan in 2025, with a CAGR of 5.3%. Cross-border e-commerce (CBEC), an emerging entry channel to China, has also become a popular option for OTC drug companies to try out the Chinese market. Euromonitor’s data shows that the CBEC market of OTC drugs achieved a CAGR of 120% from 2018 to 2021, far outpacing the growth of other retail channels. During the webinar, Angelita Hu will give a detailed introduction to the Chinese OTC market, analyze the performance of the CBEC channel and detail how to access China via CBEC….

Oct. 14th, 2022

How to Sell OTC Drugs to China via Cross-Border E-Commerce (CBEC)

To market over-the-counter (OTC) drugs in China, stakeholders used to obey the same documentation requirements and marketing authorization application procedures as prescription drugs. *Please refer to the article to learn about OTC drug marketing authorization application procedures in China. In recent years, cross-border e-commerce has been developing as a different approach to enter China\’s OTC drug market. Cross-border e-commerce (CBEC) refers to selling goods on a third-party online CBEC platform from one country to individual consumers in another country. Contents China\’s OTC Drug Market Overview Differences Between CBEC and General Trade CBEC Positive List Three Delivery Modes for CBEC How to Establish an Online Drugstore on a Chinese CBEC Platform BaiPharm\’s CBEC Service for Overseas Medical Suppliers Related Webinar Webinar: How to Sell OTC Drugs to China via Cross-Border E-Commerce 1. China\’s OTC Drug Market Overview OTC drugs in the Chinese market mainly include cold drugs, cough drugs, pain relievers, gastrointestinal…

Oct. 14th, 2022

How to Open and Manage CBEC Store on Tmall & JD?

China is the largest consuming market and Ecommerce takes 25% percent of the consumer market share, however, entering the Chinese market is a long process that requires lengthy preparation and investment.  Regulatory affair is a complicated topic for many categories of products such as cosmetics, health food, pet food, etc. Cross-border e-commerce can be a fast route for new brands and products to enter the Chinese market by selling products directly without a long registration process or setting up a company in mainland China. In this webinar, Paolo Shan, the Project Manager of Digiant will present and analyze a new way of exporting goods to China – Cross-border E-commerce and explain how it works. Contents Part 1  Why CBEC and What is CBEC a. Benefit and definition of CBEC b. Main CBEC Models c. Logistics Mode of CBEC Part 2  Ecommerce Landscape a. Digital Environment b. Main Ecommerce Platforms c. Comparison of main…

Oct. 13th, 2022

Sept 2022: New Drug Approvals in China

Editor’s Notes: New drugs in this article refer to Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China; Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China; First generic drugs in China. *”First generic drug in China” refers to the first generic drug developed by Chinese companies and approved by China National Medical Products Administration (NMPA). Technically, generic drugs are not innovative/improved drugs according to Chinese drug regulations. Yet, first generics are still included in this article because they are new in the Chinese market. Related Articles: China Chemical Drug Registration Classification China Biological Product Registration Classification Expedited Programs for Drug Registration in China In September 2022, China\’s NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Nanjing Biosnwill Medical\’s Edaravone Sublingual Tablet AstraZeneca\’s Dapagliflozin Tablets Bayer\’s Rivaroxaban Tablets AstraZeneca\’s Olaparib Tablets Yichang…

Oct. 12th, 2022
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