MFDS to improve essential drug designation standard

MFDS launches study to improve standard for designating essential medicines

Reorganizes the Safe Supply Council and Subcommittee, and prepares operation plans

The Ministry of Food and Drug Safety will conduct a study to improve the standards for designating essential medicines.

 

When the national essential medicine system was first implemented in 2017, the designation focused on government stockpiles, but there have been continuous calls to expand the list to include items that require stable supply in the private medical setting.

 

This was announced in the “Proposal Request for Research on Classification of National Essential Drugs and Measures for Stable Supply” announced by the Ministry of Food and Drug Safety on the 23rd.

 

The MFDS designates and manages essential medicines that need a stable supply because they are necessary for medical use, such as disease control and radiation disaster prevention, Efforts have been made to ensure a stable supply of essential medicines, including improving the designation criteria, introducing a reevaluation system, providing administrative support for expedited approval, and revising laws.

 

The study plans to review cases from other countries to develop measures to improve the current system.

 

Following the recruitment of researchers, KRW 50 million will be invested over a period of 6 months to conduct the following: ▲survey and compare the operation and utilization of essential medicine systems in major countries; ▲analyze the current status of national essential medicine operations and explore directions for improvement; and ▲analyze the current status of utilization and explore directions for improvement to ensure the stable supply of national essential medicines.

 

First, the study will examine the purpose of essential medicine management in other countries, classification methods (product characteristics, uses, etc.), selection criteria and procedures, and consultation processes.

 

It will also investigate the current status of policy support and preferential measures for stable supply.

 

In addition, the study will derive key considerations for designating national essential medicines based on the characteristics of each item and prepare proposals for improving the standards for designating national essential medicines.

 

The study will also review the classification methods for national essential medicines by use, referencing the WHO Model List of Essential Medicines, to revise the list.

 

The list will be revised based on a comprehensive review of the necessity of each item within the category when designating or reevaluating national essential medicines.

 

In addition, the purpose of the national essential medicines system and the need to distinguish it from similar systems will be considered, and the scope of designation and exclusion of national essential medicines be reviewed.

 

This study will also establish a reorganization and operational plan for the Stable Supply Council and Subcouncil to facilitate discussions on the designation and stable supply of national essential medicines.

 

The study will identify government policy tools and collaboration requirements with relevant ministries and agencies to ensure that stable supply policies decided through the council are implemented, and will review measures to strengthen human and material infrastructure for the stable supply of essential medicines.

 

The MFDS stated, “The supply of essential medicines continues to be an ongoing issue, and we expect the government to play a stronger role in improving the national essential medicines system and ensuring a stable supply in response to environmental changes in various fields.”