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The First Full-nutrition FSMP Approval Issued by SAMR


On August 7, 2018, the State Administration of Markets and Regulations (SAMR) issued information on the registration catalogue of FSMP.


For the first time in the catalogue, a full-nutrition FSMP is approved. So far, except for the specific nutrition FSMP, the other three types of FSMP have products being approved. The "food" of the FSMP consumer has a better guarantee.

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Product category
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In terms of product categories, FSMP are mainly divided into infant formulas FSMP, non full-nutrition FSMP, full-nutrition FSMP and specific nutrition FSMP. 

Until now, the approval rate of infant formulas FSMP is 77%, still occupying the first place. Non full-nutrition FSMP ranked in second placed. The full-nutrition FSMP is approved for the first time, and it takes the third place. only specific nutrition FSMP has not been approved, and it is expected there will be approved products in this category.

Market Share from Enterprises
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Look into the market share from the enterprises, there are currently six companies have products being registered, among which domestic companies include Beingmate and Suzhou Hengrui, and others are international enterprises. Overall, the approval rate of Abbott products accounted for 39% of the total approved products. Danone, Mead Johnson and Suzhou Hengrui ranked second with 15% respectively, and Nestlé and Beingmate ranked third.

Since November 2017, the former CFDA and the SAMR have successively published seven batches of catalogues for the registration of FSMP. Since June 2018, six products have been approved in less than two months. The only explanation is that the evaluation process is intensifying the approval on FSMP.

In the official news from the beginning of this year, 75 product registration cases of more than 20 domestic and foreign companies have been acceptted. Within half a year, the full-nutrition FSMP product has been approved for the first time, which add one more FSMP category to the FSMP family. Nowadays, infant formulas FSMP, non full-nutrition FSMP, and full-nutrition FSMP have been approved. only special nutrtion FSMP has not been approved. The main reason from the analysis of the Foodamte may be that specific nutrient FSMP needs to be clinically tested, and the company is preparing for clinical trials. The test is also taking nearly one to two years.

For more information on the previous registration details, please click here to see.

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