• Proceedings of the Korean Geotechical Society Conference
• /
• 2001.03a
• /
• pp.3-14
• /
• 2001

This study introduces the framework of the mutual recognition project of APEC Engineer and also tries to find out what we, Korean engineers have to do with this project. The mutual recognition framework consists of 2 main frameworks ; the substantial equivalence framework and the mutual exemption framework. The participating Economies have discussed and agreed on the framework of the substantial equivalency and have been producing APEC Engineers from the 1st, Nov 2000 based on this agreement. However, more discussions will be required from now on in order to finalize the mutual exemption agreement, even though there have been a lot of discussions including the workshop for the regulatory authority for the last 5 years. Here we have to study and find out what we have to do with this project and prepare for the bilateral agreements and the Coordinating Committee meeting to be held in Hongkong in Oct this year.

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