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NEWS
China Prioritizes Review and Approval for FSMP for Rare Diseases
Sep 21, 2023
According to an official media release on September 12, 2023, State Administration for Market Regulation (SAMR) plans to revise the Administrative Measures for Registration of Foods for Special Medical Purpose, shortening the review period for urgent clinical needs related to FSMP for rare diseases from 60 to 30 working days, and prioritizing the on-site inspections and sample testing for these FSMP products. Also, SAMR is currently trialing this priority review and approval process.
Chinese Mainland
FSMP
Registration
NEWS
China Solicits Feedback on Clinical Trial Quality Management Standard for FSMP
Aug 31, 2023
On August 24, 2023, the State Administration for Market Regulation (SAMR) of China released an exposure draft of Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (FSMP). The draft introduces substantial changes from the 2016 Trial Standard in areas like responsibilities of FSMP participants, timelines, definitions, and the content of protocols and final reports. Any comments can be submitted before September 24, 2023.
Chinese Mainland
FSMP
Registration
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
NEWS
Regulatory Insights from the 29th Annual Meeting of China Dairy Industry Association
Jun 15, 2023
Recently, with the 29th annual meeting held in Nanchang, Jiangxi Province, a large number of officials and professionals gathered there. This article summarizes the regulatory dynamics in China's dairy industry revealed at this meeting.
Chinese Mainland
Infant Formula
FSMP
Dairy
Regulation & Standard
NEWS
China Consults on Administrative Measures for Health Food, FSMP, Drug and Medical Device Advertising
Jun 01, 2023
On May 29, 2023, the State Administration for Market Regulation (SAMR) released a consultation draft of Administrative Measures on the Review of Health Food, FSMP, Drug and Medical Device Advertisements. This draft revises the Interim Administrative Measures to address issues that have arisen since its implementation. Major revisions include the regulation of internet live-streaming and advertising for health foods and food for special medical purposes (FSMP). Any comments can be submitted before June 28, 2023.
Chinese Mainland
Health Supplement
FSMP
Advertising
NEWS
Canada Unveils Guidance on Production and Marketing of Infant Formula & Human Milk Fortifiers
Apr 11, 2023
On March 28, 2023, Health Canada unveiled a series of guidance documents on the production control and marketing approval of infant formula milk powder and human milk fortifiers (HMFs).
Infant Formula
FSMP
Production
Importation
Canada
NEWS
Exploring the Future of Special Foods in China: A Review of the 7th Special Food Conference
Apr 03, 2023
The 7th China Special Food Conference closed on March 25, 2023 in Jinan. As this conference was mainly about special foods, the themes of most sessions focused on health foods, infant formula, and FSMP products. In this article, ChemLinked summarized the key points shared by officials as below.
Chinese Mainland
Infant Formula
Health Supplement
FSMP
Regulation & Standard
NEWS
China to Revise GB 25596 General Rules of Infant Formula for Special Medical Purposes
Feb 17, 2023
On February 13, 2023, China released an amendment draft to GB 25596-2010 General Rules of Infant Formula for Special Medical Purposes, along with other 37 GB food standard drafts. The proposed standard applies to food for special medical purposes (FSMP) of consumers from 1 to 12 months, which is the same as the current standard. The revision mainly involves definition, FSMP types and technical requirements. Any feedback can be sent back prior to March 20, 2023.
Chinese Mainland
FSMP
Regulation & Standard
NEWS
China Unveils 38 National Food Safety Standard Drafts
Feb 16, 2023
On February 13, 2023, the Department of Food Safety Standards, Risk Surveillance and Assessment under China National Health Commission (NHC) released the exposure drafts of 38 national food safety standards, which include 12 newly established standards, 21 newly revised standards, and 5 amendment sheets. These drafts mainly cover standards for contaminant limits, food products, nutritional fortification substance, foods for special dietary use, food additives and food-related products. All drafts are available for public comments prior to March 20, 2023.
Chinese Mainland
FSMP
FSDU
Beverage
Food Additives
FCM
Complementary Baby Food
Regulation & Standard
NEWS
[Updated] Taiwan Removes the Use Restrictions of 2′-FL on Infant Formula for Special Medical Purposes
Feb 08, 2023
On September 20, 2022, Taiwan Food and Drug Administration (TFDA) consulted on the amendment to the use restriction of 2′-fucosyllactose (2′-FL) produced by genetically modified Escherichia coli strain K-12 DH1 MDO MAP1001d (hereinafter referred to as “E. coli K-12 MAP1001d”) and genetically modified Escherichia coli strain BL21 (DE3) #1540 (hereinafter referred to as “E. coli BL21 (DE3) #1540”). Any comments on the drafts shall be returned within 60 days since September 20, 2022.
Taiwan, China
Infant Formula
FSMP
Regulation & Standard
Pre
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