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ANALYSIS
Status Quo of China’s FSMP Registration in 2023 H1
Jul 14, 2023
According to the data from Special Food Information Query Platform, 24 food for special medical purposes (FSMP) products were granted registration approval in 2023 H1. Among them, one imported product was approved.
Chinese Mainland
FSMP
ANALYSIS
Status Quo of China’s FSMP Registration in 2022 H1
Jul 15, 2022
According to the data sourced from the State Administration for Market Regulation (SAMR), only two food for special medical purposes (FSMP) products were granted registration approval during the first half of 2022, and both are from China.
Chinese Mainland
FSMP
Registration
ANALYSIS
The Status Quo of FSMP Registration in 2021H1
Jul 26, 2021
15 foods for special medical purposes products (FSMP) obtained registration approval in 2021H1. All of them are produced by domestic enterprises. By the end of June 2021, 72 FSMP products were registered in China. FSMP for infants accounted for 50% of all. Among them, premature/low birth weight infant formula, lactose free formula and partially-hydrolyzed lactoprotein infant formula occupy the majority.
Chinese Mainland
FSMP
Registration
ANALYSIS
Interpretation of Implementation Rules of Food Safety Law, 2019 – Impact on Administration of Special Food
Nov 05, 2019
The State Council has included considerable detail in the Food Safety Law Implementation Rules on regulation of health food, infant formula and food for special medical purposes. Changes in the Rules reflect the major tasks and goals of the government in food safety, market supervision, education, regulation of ecommerce supply chains and random inspections.
Chinese Mainland
Infant Formula
Health Supplement
FSMP
ANALYSIS
Preparatory Work for Special Food Registration/Filing in China
Oct 31, 2018
Chinese Mainland
Infant Formula
Health Supplement
FSMP
Registration
ANALYSIS
Recent Updates of China’s FSMP Registration Rules
Dec 28, 2017
Chinese Mainland
FSMP
Registration
ANALYSIS
Significant Revision to Foods for Special Medical Purpose Registration Requirements in China
Sep 30, 2017
Chinese Mainland
FSMP
Regulation & Standard
ANALYSIS
China’s New Food Legislative Framework
Nov 15, 2016
1. With the release of the “Food Safety Law Implementation Rules”, the framework of China’s new food legislative framework has been formed. 2. More than 40 administrative regulations have been issued to implement the key articles of the new Food Safety Law. 3. In general, the new food safety legislative framework will increase market access prerequisites, stringency and frequency of inspections and regulatory requirements. 4. At a domestic level we can expect closure of many substandard food enterprises and for importers we can expect more technically demanding barriers to trade.
Chinese Mainland
Infant Formula
Health Supplement
FSMP
ANALYSIS
Understanding China Food for Special Medical Purposes Clinical Trial Requirements
Oct 10, 2016
1. Clinical trial requirements for FSMPs are similar to pharmaceutical requirements. 2. The government provides 13 broad categories of disorders as examples in which FSMPs may be of therapeutic benefit however products are not limited to these categories. 3. Difficulties in substantiating scientifically significant therapeutic/clinical benefit, trail size requirements and cost are major difficulties for successfully meeting China’s FSMP registration requirements.
Chinese Mainland
FSMP
ANALYSIS
Comparative Analysis of Regulations on Health Food and FSMPs in China
Aug 26, 2016
Health food and foods for special medical purpose (FSMP) are both regulated as special food in China in accordance with the new Food Safety Law. As two important food categories of special food, their major differences are compared in the aspects of targeted consumption groups, raw materials, product formula, function claims, etc.
Chinese Mainland
Health Supplement
FSMP
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