Government to Manage Medicines Needed for Temporary Demand Surges

Legislative Amendments Overseen by the Ministry of Food and Drug Safety,
Including the 'Pharmaceutical Affairs Act,' Passed at National Assembly Plenary Session

The Ministry of Food and Drug Safety announced on October 27 that four legislative amendments, including the Pharmaceutical Affairs Act, were passed at the National Assembly plenary session the previous day.

First, under the amendment to the Pharmaceutical Affairs Act, the 'National Essential Medicines Stable Supply Council' will now be able to discuss items that require stable supply due to temporary increases in demand, among other reasons.

Additionally, the council will be expanded and reorganized to include private sector participation, allowing the opinions of patient groups and healthcare professionals to be reflected.

The National Essential Medicines Stable Supply Council is an organization that designates medicines as national essential medicines when they are crucial for public health but face unstable supply, and discusses necessary measures to ensure their stable supply.

Furthermore, a legal basis has been established for the creation of the 'Natural Products Safety Management Research Institute,' which aims to ensure the safety and improve the quality of medicines derived from natural products.

The Ministry of Food and Drug Safety also amended the Narcotics Control Act, requiring narcotics handlers who report business closure to submit their inventory status and disposal plans for narcotics. This is to systematically manage any remaining narcotics after business closure. In addition, if narcotics are disposed of or transferred after closure, it must be reported to the Narcotics Integrated Management System.

The Hygiene Products Control Act was also amended, so that hygiene products with a low risk of harm and those imported repeatedly will now be automatically inspected and approved upon notification. Samples or promotional items brought in free of charge for exhibitions, fairs, and similar events will be exempt from import notification requirements.

The Act on Testing and Inspection in the Fields of Food and Pharmaceuticals was also revised. As a result, if the head of a testing and inspection agency does not directly engage in testing and inspection work, a responsible person may be designated to receive training on behalf of the head.