이 누리집은 대한민국 공식 전자정부 누리집입니다.
Biz News Korea(Eng)
Korea to give medical suppliers better access to human-derived materials
- Collected
- 2023.11.27
- Distributed
- 2023.11.28
- Source
- Go Direct
Human-derived materials refer to any parts of the human body, as well as secretions or excretions collected from the body, including blood, tissues, cells, and organs.
The current law requires manufacturers of in vitro diagnostic devices to submit requests to human-derived materials banks and undergo a rigorous review each time they need various materials for clinical testing during their product manufacturing.
But this practice caused inefficiencies, as manufacturers had to identify which banks have the materials they need and undergo the complicated application and safety review procedures.
As part of its effort to streamline the practice, the regulatory authority recently decided to set up a nationwide committee among the banks during the latest meeting moderated by Prime Minister Han Duck-soo on Sunday. The committee will have its office at the Daejeon Bio-Medical Regulation Free Special Zone, a district known for its regulatory sandbox approach, to review the requests.
By Kim Si-gyun and Han Yubin
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