Increased User Fees for Drug Applications in Korea

The Korea Food and Drug Administration (KFDA) recently announced plans to increase application fees for drug applications. The KFDA plans to increase fees starting July 1 and then increase the fees again starting January 2009.

For New Drug Applications (NDA), the application fees per product will increase almost 7 times from approximately $400 to $3,000 during the first increase. For the second increase starting in January 2009, the application fee will increase to approximately $4,000. In Korea, a new drug is defined as a product not previously registered or marketed in Korea for medicinal purposes. This definition also includes any new salts and esters of an active substance, new fixed combinations of previously marketed substances, or any previously marketed drug whose indication, mode of administration, or formulation changes.

Abbreviated New Drug Applications (ANDA) will have increased application fees per product from approximately $400 to $1,000. The second increase will be a new application fee of approximately $1,500. In Korea, ANDA usually refers to the registration of new dosage forms, new strengths, and new claims of an already registered chemical entity.

The application fee for Brand Generics will increase from approximately $30 to $600 per product in the first increase, and then $800 in the second increase. These fees will differ slightly if the application requires pharmaceutical equivalency testing or a bio-equivalency study. Brand generics refer to drugs produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient.

Other applications, such as generic products whose formulation is exactly the same as those listed in one of the foreign pharmacopoeias, will also be subject to application fee increases. Current application fees of approximately $10 will increase to $70 in the first increase and $100 in the second increase.

Orphan drug approval will also have increased application fees, from approximately $60 to $1,200 in the first increase to almost $2,000 in the second increase.