The year 2016 is a watershed in Chinese health food management reform, changing from the registration system lasting 20 years to the dual-track management system (registration and filing). Nearly 150 imported health food filing certificates have been issued until now since filing management implemented in May, 2017, compared with about 250 in total of imported health food registrations approved in the 13 years between 2003 and 2016, suggesting a simplified application process and requirements to some extent, so that imported food supplements can enter the Chinese market more smoothly.
On February 20th, 2021, SAMR released Dosage forms and Technical Requirements of Health Food Filing (2021 version), adding gelatin candy and powder as allowed forms and this regulation will be effective since 1st of June, 2021. Previously, the permitted forms are capsule (hard and soft), oral liquid or granule. At present, with the addition of these two forms, it is believed that more high-quality imported food supplements can quickly enter the Chinese market through the filing system and Chinese health food market will be further motivated.
This Webinar is focusing on extra requirements on filing of imported food supplements in gelatin candy and powder forms compared with filing requirements on the food supplements in other forms, including the introduction on the required process, documents, and other points for attention for filing process.
U.S.-China Health Products Association
May 12th 2021
May 13th 2021
May 13th 2021
Training Topics and Content
Background: the specific requirements for producing and importing the food supplements in gelatin candy and powder forms
- Suitable crowds, unsuitable crowds, daily intake and specification of gelatin candy and powder products;
- Main producing process of gelatin candy and powder products;
- Product technical requirements of gelatin candy and powder products;
- Allowed excipients of gelatin candy and powder products;
Topic 1: The Process and Duration of Imported Health Food Filing
- Introduction of imported health food filing process (product filing and applicant account application)
- Detailed introduction on the application steps and diagrams of oversea applicant account
- Detailed introduction on the application steps and diagrams of health food filing
- The timeline of imported health food filing
- How to shorten the entire filing cycle?
Topic 2: The requirements on documents of imported health food filing
- Documents that shall be submitted for applicant account application
- Documents that shall be submitted for imported health food filing
- For filing affairs run by domestic agency, what materials can be prepared by the agent?
- Test items and requirements for filing process
- Notice and tips when preparing the documents
Ms. Cathy Yu, Senior Food Regulatory Consultant
Ms. Cathy Yu's major in university was food science and engineering, she is very familiar with food industry, and has extensive experience in China food and food contact material laws and regulations. She has been invited to Germany, France, the United States, South Korea and many other regions to give the training to foreign food related companies in international regulatory conferences. She works in CIRS Group for more than 8 years and leads the Food Business Division to assist global well-known companies.
Ms. Lena Ma, Food Regulatory Specialist
Ms. Lena Ma graduated from Jiangnan University with a Master Degree in Food Engineering. After joining CIRS, she focuses on Chinese health food regulations and policies. She is mainly responsible for health food registration/filing, and is professional in food regulatory support for domestic and oversea enterprises.
Mr. Hui Xu, Food Regulatory Consultant
Mr. Hui Xu has a deep research into food related regulations. He is especially professional in the new food raw materials, new food additives, new food contact material and health food registration. He is devoted to providing food regulatory services for Japanese companies.
Ms. Doris Huang, Food Regulatory Consultant
Ms. Doris Huang graduated from Wageningen University with a Master degree in food quality and management. She is familiar with the latest food supplement, FSMP, infant formula related regulations and trends, and is an expert in providing overseas enterprises with regulatory compliance consultancy.
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Chemical Inspection & Regulation Service (CIRS China)
Addr: 11/F., Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
TEL: +86 571 8720 6574