Legislation of ‘INN prescriptions’ for drugs begin

Which recommends international non-proprietary name prescriptions of out-of-stock and National Essential Medicines

Will newly establish a definition for drugs in unstable supply and grant them the same status as national essential medicines

Korea Orphan & Essential Drug Center will exclusively mark drugs in unstable supply

Representative Yoon Kim presented a Bill for the Amendment to the Pharmaceutical Affairs Act as representative

The government is promoting legislation to recommend international non-proprietary name prescriptions for national essential medicines and drugs with unstable supply and demand and to encourage the use of 'product name and the international non-proprietary name’ when obtaining a marketing authorization.

 

The bill also includes a provision that requires the government to establish a policy to resolve stockouts by legislating the definition of unstable drugs and giving them the same status as national essential medicines.

 

The legislation recommends that the government prescribe and approve the use of ingredient names only for drugs with unstable supply and national essential medicines, which are frequently out of stock and cause inconvenience to pharmacies and patients.  On the 2nd, Rep.

 

Yoon Kim, a member of the Democratic Party of Korea, introduced a bill as representative to amend the Pharmaceutical Affairs Act.  First, the bill defines an unstable supply drug as a drug designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety in consultation as a drug that needs to secure a stable supply due to unstable supply and demand.  The amendment puts unstable drugs on the same level as national essential medicines.

 

The Minister of Welfare and the Minister of Food and Drug Safety are obligated to carry out support tasks to promote the production and utilization of drugs with the same ingredients as drugs with unstable supply and demand.

 

The Minister of Welfare and the Minister of Food and Drug Safety are required to establish and promote comprehensive measures to stabilize the supply of drugs with unstable supply and demand and to support the establishment of a stable supply base, research and development, and safe use.

 

Recommendation of international non-proprietary name prescriptions and approving ingredient-containing product names In particular, the law recommends doctors prescribe ingredient names for national essential medicines and drugs with unstable supply and demand and encourages pharmaceutical companies to receive marketing authorization based on ingredient-containing product names.

 

Specifically, the Minister of Welfare is required to establish a policy to activate the use of ingredient names for nationally essential medicines and drugs with unstable supply and demand in prescriptions.

 

This provision has the effect of encouraging the prescription of nationally essential medicines and drugs with unstable supply and demand.

 

In addition, the Minister of Food and Drug Safety recommends the use of international non-proprietary names for those who intend to sell or import national essential medicines and drugs with unstable supply and demand.

 

The Minister of Food and Drug Safety can provide administrative and financial support for those who want to sell and import nationally essential medicines, etc.

 

Through the provision, the government recommends pharmaceutical companies planning to sell and import drugs with domestic marketing authorizations to include the names of ingredients in the product names.

 

The law also stipulates that the MFDS National Council for Stable Supply of Essential Drugs shall consult on matters related to national essential medicines.  The Korea Orphan & Essential Drug Center will manage drugs with unstable supply along with national essential medicines.

 

The amendment is expected to create a government organization dedicated to drugs with unstable supply and demand.

 

“In recent years, the problem of unstable supply and demand of certain drugs has not been easily resolved and is often prolonged,” said Rep Yoon Kim.

 

”This causes problems within the drug supply process, from distribution to consumer purchases, such as stockpiling, issuing long-term prescriptions, and over-the-top trading between pharmacies.” “Therefore, the government will establish a stable supply mechanism for drugs with unstable supply and demand and promote the use of international proprietary names for nationally essential medicines to lay the foundation for stable and timely supply of drugs to consumers.” Yoon Kim was joined in the bill by Democratic Party members Gi-Pyo Kim, Nam-Geun Kim, Nam-Hee Kim, Seung-won Kim, In-soon Nam, Ji-won Park, Hae-Cheol Park, Hee-Seung Park, Seung-A Bak, Hoon-Gi Lee, and Mi-ae Lim.