MFDS recruits companies to develop 6 National Essential Drug

including amiodarone etc.

Among 11 finished and raw materials will additionally recruit developers for items only a single company applied for

MFDS will invest KRW 5 billion for 5 years... 4 items to be selected in the first stage of the project

The government is busy recruiting institutions to develop domestic manufacturing technology for items that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines.

 

The Ministry of Food and Drug Safety had recently selected 11 products, including 5 raw materials and 6 finished products, as candidates for Stage 1 development after deliberation by the Product Selection Committee, and posted an open recruitment for developers on the webpages of research institutions including Korea Orphan & Essential Drug Center and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association.

 

The government will additionally recruit developers for items only a single company had applied for, which include 2 finished products (‘Amiodarone Inj,’ ‘stiripentol Cap’) and 4 APIs (‘amiodarone (amiodarone tablet, injection),’ ‘ibuprofen (ibuprofen injection 5mg/ml),’ ‘ketoconazole (ketoconazole tablet),’ ‘benserazide (levodopa, benserazide tablets)’).

 

Although there is no limit to the number of development projects each institution may apply for, if the same applicant applies to develop the APIs that are candidates for a stable supply of national essential drugs and use them for the development and production of the finished drugs, the items will be recognized as two separate items and be supported separate R&D expenses.

 

The MFDS selected drugs that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines and has been carrying out the ‘Research Project for Managing Stable Supply of National Essential Drugs’ from this year until 2026.

 

Despite the need to maintain a stable supply of national essential drugs at all times, there recently has been a shortage of raw materials as well as finished drugs internationally due to the COVID-19 outbreak.

 

In particular, Korea is heavily dependent on imported drugs, therefore criticism had been raised on the need to prepare a supply chain for essential drugs in case of the rise of public health crises in the future.

 

in The MFDS will invest a total of KRW 5 billion for 5 years - KRW 1 billion each year- to build a stable supply system for national essential drugs that have supply concerns and will aim to develop raw materials and finished drug production technology for domestic production.

 

In the first stage (first-second year) of the project, the development targets will be selected and over 40% of the technology for the target drugs will be developed.

 

In the second stage (third-fifth year), the remaining technology will be developed and be subject to comprehensive assessments.

 

The MFDS said, "In addition to developing the technology for the localization and self-sufficiency of API manufacturing, we will also expand the recognition of multiple specifications of APIs when adding API manufacturers to diversify the supply chain for APIs.

 

Also, if a disruption in supply is expected, we will promptly handle related complaints including adding drug substance manufacturers, etc."