• 최종편집 2024-07-15(월)
 

350eebaa-6b83-4a78-968a.jpg

 

On the occasion of the state visit of President Yoon Suk Yeol, the Ministry  of  Food and  Drug  Safety (MFDS)  of the  Republic  of Korea  (Minister  Oh  Yu-Kyoung) met  with  Dr.  Robert  M.  Califf, Commissioner  of  the  US  Food  and  Drug  Administration  (FDA)  to discuss  cooperation  between  the  two  organizations  in  the  field  of digital health and signed a Memorandum of Cooperation (MOC*) on April 27 (local time) to strengthen cooperation on medical products using artificial intelligence (AI). 


The  signing  of  the  MOC  is  part  of  the  strengthening  of cooperation in the Korea-U.S. high-tech alliance and supports the core and emerging technology cooperation agreed upon by the two leaders.  It  was  also  promoted  as  a  follow-up  to  the  meeting between  Minister Oh Yu-Kyoung and  Commissioner  Robert Califf in March. 


Specifically, it was designed to ▲ share experiences in using AI for  medical  product  development  ▲  discuss  ways  to  promote  the use of innovative technologies to develop effective and safe medical products  ▲  and  promote  the  harmonization  of  medical  product regulations using AI, which is jointly led by the MFDS and the US FDA.  


AI technology, which has been rapidly developing in recent years, is  increasingly  being  utilized  in  the  field  of  medical  product development. In particular, with the advent of the borderless digital era based on the cloud, regulatory agencies in each country agree on the need for international harmonization of the regulatory system to  promote  the  development  of  medical  products  using  AI technology and support their rapid use on site.


Against  this  backdrop,  the  signing  of  the  MOC  is  significant  as both  organizations  have  recognized  the  importance of  international harmonization in the digital health sector and have taken the first step  for  considering  and  discussing  together  to  activate  the development of medical products using AI technology. 


Building  on  the  signing  of  this  MOC,  the  two  organizations  will hold joint workshops to share experiences in using AI for medical product  development  with  regulators  from  around  the  world  and discuss  how  regulators  can  help  advance  the  use  of  innovative technologies to deliver safe and effective medical products.


MFDS will continue and develop in-depth discussions with the US FDA based on the joint workshop so that the results of the joint workshop can be used as a global standard. Based on this, we will strengthen  regulatory  support  to  revitalize  the  development  and export  of  medical  products  using  AI,  such  as  refining  the  system more rationally and taking initiative in setting guidelines.

Prior to this, on April 26 (local time), Minister Oh visited WellDoc, a  US-based  company  that  received  approval  for  its  digital therapeutics for the first time in the world. She shared her views on recent global market trends and future development directions in the digital health sector. 


In  addition,  on  April  26  (local  time),  the  Minister  attended  the '2023  APEC  Medical  Product  Supply  Chain  Dialogue'  event  at  the United States Pharmacopeia (USP), where she shared Korea's best policy  practices  for  the  pharmaceutical  supply  chain.  She  also discussed with USP representative Dr. Ronald Piervincenzi ways to actively cooperate with each other, including ways to promote joint research on innovative medicines and human resource exchange. 


The  visit  laid  the  groundwork  for  concrete  and  practical cooperation  with  the  US  FDA  and  USP  in  the  field  of  medical products.  MFDS  will  continue  to  expand  cooperation  on  issues  of common  interest,  such  as  clinical  trials  and  food  safety management. The Korea Medical Devices Industry Association and the  Korea  Pharmaceutical  and  Bio-Pharma  Manufacturers Association  commented  on  the  bilateral  cooperation  that  they welcome  the  MFDS’  advanced  regulatory  science  activities  and international  harmonization  efforts  to  support  Korean  companies' initiatives in overseas markets.


MFDS will spare no efforts to expand our role on the global stage through  multifaceted  cooperation  with  food  and  drug  regulatory agencies  around  the  world.  The  Ministry  will  proactively  prepare regulations  for  medical  products  applied  with  innovative  future technologies so that Korea's regulations can soon become a global regulatory standard.


BEST 뉴스

비밀번호 :
메일보내기닫기
기사제목
Korea-U.S. High-Tech Alliance to Set Global Standards
보내는 분 이메일
받는 분 이메일