K-API·listed essential medicine to get preferential price

MOHW shifts its initial stance of providing a 'preferential price for newly listed essential medicines'

Preferential track for domestic API was implemented in March, '0 cases' of pharmaceutical companies that applied…a follow-up measure after it was pointed out during the parliamentary inspection

The roadmap for API self-sufficiency was submitted to Rep. Baek Jong-heon's office

Minister Jeong Eun Kyung promised Rep.

 

Baek Jong-heon to implement the

The Ministry of Health and Welfare (MOHW) has decided to expand eligibility for the 68% preferential drug price for National Essential Medicines that use domestic active pharmaceutical ingredients (API).

 

The MOHW aims to foster the domestic industry by incentivizing the use of domestically sourced API.

 

The MOHW is shifting its initial stance—which applied the 68% preferential drug price only to essential medicines that received marketing authorization after the policy's implementation in March of this year—to granting the 68% preferential price to already listed products.

 

Notably, the MOHW will also add the measure of domestic API self-sufficiency to its ongoing research on advanced policies for drugs with unstable supply.

 

Furthermore, it plans to review the need for a preferential drug price for combination drugs using domestic API at a later stage.

 

This is a follow-up measure by the MOHW after Rep.

 

Baek Jong-heon (People Power Party) criticized Minister Jeong Eun Kyung during a parliamentary inspection this year, pointing out a policy failure: not a single pharmaceutical company had applied for or benefited from the 68% preferential prices of essential medicines.

 

This announcement is from the 'Roadmap for Fostering Domestic Active Pharmaceutical Ingredients' submitted by the MOHW to Rep.

 

Baek Jong-heon's office on October 29.

 

According to the documents submitted to the representative's office, the MOHW will expand the eligibility for the 68% domestic API preferential drug price, currently applied only to newly listed National Essential Medicines, to include 'already listed essential medicines.' To establish this, the MOHW stated that it initiated a survey on the status of domestic API-using drugs held by domestic pharmaceutical companies on the 20th, through organizations such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and the Korea Biomedicine Industry Association.

 

Rep.

 

Baek explained that, based on the survey results, essential medicines that were already listed and had obtained National Health Insurance drug prices before the implementation of the preferential policy in March are expected to receive a retroactive application of the 68% price hike.

 

The MOHW also decided to include strategies for API self-sufficiency in the ongoing research service to analyze trends and stabilize the supply of drugs with unstable supply (from September to November 2025).

 

Upon completion of this research, the ministry will consider commissioning additional research to develop an API self-sufficiency roadmap.

 

The MOHW plans to increase the Korea Health Industry Development Institute (KHIDI) budget by KRW 100 million next year for this purpose.

 

The MOHW stated, "Next year's project to strengthen API self-sufficiency will address the excessive reliance on specific countries for imported APIs, such as China (35%) and India (15%)," and stressed, "We are also pursuing the expansion of the 68% preferential drug price for National Essential Medicines using domestic API to include already listed essential medicines.

 

We are currently confirming the status and gathering opinions through the pharmaceutical and biotech organizations."