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Aekyung Registers AK3 with China NMPA

Because of this, it is considered a difficult area for domestic companies to tackle directly due... In particular, it is the first case to prove skin moisturizing efficacy in China. This...

Aekyung Registers AK3 with China NMPA

Aekyung Says AK3 Completed New Ingredient Registration on April 29

Aekyung Industrial has officially completed the registration of its proprietary pseudo-ceramide material ‘AK3’ as a new cosmetic ingredient with China’s National Medical Products Administration (NMPA).

Aekyung Industrial announced on April 29 that its proprietary pseudo-ceramide material ‘AK3’ has officially completed registration as a new cosmetic ingredient with China’s National Medical Products Administration (NMPA).

With this registration, AK3 has completed the essential procedures to be utilized as a cosmetic ingredient in the Chinese market.

Ingredients used for the first time in cosmetics in China must undergo a strict review under the supervision of the Chinese NMPA. In particular, for ingredients produced overseas, extensive data must be submitted, including physical and chemical characteristics, manufacturing processes, toxicological safety evaluations, skin irritation and allergic reaction tests, and efficacy verification data, and distinct from existing domestic and global test data, an independent evaluation must be received at a testing institution within China designated by the Chinese NMPA. Because of this, it is considered a difficult area for domestic companies to tackle directly due to the high costs and lengthy review periods.

In reality, although the threshold was somewhat lowered when the NMPA’s new cosmetic ingredient registration system in China was revised in 2021, cases of completed registration remain limited. According to the results of statistical analysis from the revision in 2021 until April 2024, the cumulative number of new ingredient registrations in China is 444, and among these, the number of new ingredient registrations for ingredients produced in countries other than China is merely 66, while new ingredient registrations for ingredients produced in Korea account for about a 1% level.

Aekyung Industrial’s AK3 has become the fifth registration case by domestic standards since the system revision in 2021. In particular, it is the first case to prove skin moisturizing efficacy in China.

This achievement was accomplished through a regulatory response project promoted under the support of the Ministry of Health and Welfare’s ‘Innovative Growth Skin Health Basic Technology Development Project’. Aekyung Industrial has been carrying out this project since 2023, focusing on the advancement of global regulatory response capabilities and material technology.

Aekyung Industrial plans to accelerate its penetration of the Chinese market using this new ingredient registration as momentum.

Kim Han-young, head of the Beauty Convergence Research Team at Aekyung Industrial’s Cosmetics Research Institute, said, “The new ingredient registration of AK3 with the Chinese NMPA is a meaningful achievement in which Aekyung Industrial’s proprietary material technology and quality competitiveness have been recognized in the global market,” and added, “We will continue to contribute to enhancing the competitiveness of the K-beauty industry through differentiated ingredient research and development and the strengthening of global regulatory response capabilities.”

Choi Mun-hee

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