In 2021-1st Review Results of the New Excellent Technology (NET) Specialized Subcommittee, "HIS-linked cylinder type drug mixing device system and kit set in a closed state, anti-cancer (injection) preparation and injection integrated device" had been decided as "pending" with the condition of submitting a supplementary document.

# Review Result

-       After the 2016 New Excellent Technology (NET) certification, evidence of advanced performance and differentiation is required, and it is judged that it is necessary to submit it by reflecting this in the purpose of use of the KFDA license

-       The necessity and advancement of the product are partially recognized for the product subject to this technology, but it is necessary to submit a certified test report for qualitative evaluation of the quantitative dispensing technology for each preparation target product, and the test result of installing and removing the preparation kit in the air is also required.

-       Additional data on differentiation and excellence compared to the already certified NET technology are required.

-       It is reasonable to proceed with approval process of the Ministry of Food and Drug Safety as an item suitable for the purpose of use, and to decide whether to approve it by reviewing the safety and efficacy data obtained in this process.

-       The necessity of submitting evidence from an accredited institution that can prove the performance and effectiveness of automatic dispensing, and deleting the HIS linkage part from the name of the applied technology or supplement the insufficient data since patents or data related to HIS linkage are insufficient,.

As above, the company's patented technology, "Injection preparation kit and injection preparation system" is the result of the examination by the Expert Committee for the 1st NET certification examination in 2021-1st.

As soon as the requested data are ready, we will request a re-examination.

Thank you.