• Korea Trade Review
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• v.48 no.3
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• pp.131-150
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• 2023

The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

• Journal of the Korean Applied Science and Technology
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• v.41 no.1
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• pp.9-18
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• 2024

Smilax china is known for its excellent antimicrobial, antioxidant, and anti-inflammatory properties. As a foundational study for applying the functionality of Smilax china extracts to cosmetics, it is necessory to investigate the concentration-dependent skin permation characteristics of the flavonoids in the extract, namely quercetin, catechin, and naringenin. Therefore, it serves as a crucial method for conducting this basic research on the functional aspects fo Smilax china extracts for cosmetic applications. This investigation focused on examining the percutaneous permeability characteristics of flavonoids originating from Smilax china. Applying Marzulli's definition, the Kp value of quercetin was categorized as "fast" at 0.1 mg/mL and "moderate" at 0.2 and 0.4 mg/mL. Notably, the permeation rate exhibited a decline with increasing concentration. For naringenin, Flux values were 0.69, 1.07, and 1.42 ㎍/hr/cm² at concentrations of 0.1, 0.2, and 0.4 mg/mL, respectively, with corresponding Kp values of 6.95, 5.34, and 3.56. Naringenin's Kp value fell into the "moderate" category across all concentrations, and as observed with quercetin, the permeation rate decreased with higher concentrations. Likewise, for catechin, Flux values were 0.75, 1.09, and 1.66 ㎍/hr/cm², and corresponding Kp values were 7.55, 5.46, and 4.16. Catechin's Kp value was consistently classified as "moderate" across all concentrations. The efficacy of quercetin, catechin, and naringenin, active ingredients in high-performance and anti-inflammatory Smilax china extracts, was found to exhibit skin penetration properties above the average. This confirms their suitability as excellent natural materials for use in functional cosmetics, given their outstanding capabilities in preventing acne and reducing inflammation.