• The Journal of the Convergence on Culture Technology
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• v.7 no.4
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• pp.833-844
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• 2021

In the era of Corona, companion animals provide a lot of comfort to people, and the Pet Pam group, who thinks of companion animals as family members, has appeared. There is also the Pet Pour phenomenon, in which young consumers spend less on their pets and spend on their companion animals. Despite these changes in the times, pet products, including pet food, are still highly dependent on imports. In addition, since domestic standards for cosmetics and supplies for companion animals have not been established, they rely only on cosmetic safety standards and regulations. In addition, the terminology for domestic pet cosmetics has not been established yet. Currently, only the Animal Protection Act related to companion animals has been amended in the domestic law, but in the case of Japan, the Companion Animal Feed Safety Act came into effect in June 2009. In the United States, the federal Food, Drug, and Cosmetic Control Act covers pet cosmetics and supplies. Germany, which has strong animal protection laws, has various national regulations on food and feed, and detailed national regulations are also provided on the website of the Food Safety Administration. National policies and environments should be established to manage and develop the companion animal industry in Korea as in such a country, and it is considered essential for the development of companion animal cosmetics and various companion animal industries.

• 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).