KOTRA 대표 홈페이지
해외비즈니스 정보 포털
수출바우처 · 지사화
외투기업고충처리
투자유치정보제공
국내 · 해외전시정보
수출지원 온라인 플랫폼
경제외교 활용포털
해외전문인력유치센터
방산물자교역지원센터
무역투자빅데이터
Background of the Initiative Following the global instability in the supply of pharmaceuticals caused by the COVID-19 pandemic, concerns have arisen not only over the disruption in the production, import, and supply of medicines but also the current situation of "shortages," which should be reported in advance for preparedness (highlighted during the 2023 National Assembly audit of the Ministry of Food and Drug Safety). In response, the Prime Minister's Order has been amended to expand the reporting scope to include cases where pharmaceutical production and imports are planned to be reduced below a certain level (October 2024). Additionally, to facilitate easier reporting for businesses, the amendment aims to establish reporting deadlines and standards for shortage reporting and plan changes, as delegated by higher regulations.
Need for Government Intervention In the past, shortage reporting was operated as a recommendation. However, it is now mandatory to establish criteria for businesses required to report any plans to reduce the production or import of finished pharmaceutical products. This provides businesses with clear standards for reporting shortages. The government seeks to proactively identify information about the pharmaceuticals in short supply and take necessary measures to ensure that there are no difficulties in the supply of medicines, so that citizens will not face challenges in accessing essential medications.
Regulatory Content The newly established shortage reporting system aims to set clear criteria for the reduction of production and imports, as well as the reporting targets as delegated by the Prime Minister's Order. It also seeks to establish reporting deadlines in the event of changes to production or import plans.
Regulatory Goal By clarifying the criteria for reductions in production and imports and the reporting targets, the goal is to facilitate the reporting of supply shortages by businesses. This will enable appropriate administrative actions to address shortages of pharmaceuticals, minimizing medical service gaps for patients. Additionally, to reduce the burden on businesses in cases where production or import plans change unexpectedly, flexible reporting deadlines will be provided.
