New Drug Master File Application Requirements for Korea

The Korea Food & Drug Administration (KFDA) recently announced that 22 drug substances would be subject to drug master file (DMF) registration by the end of 2007. Any imports of these drug substances or products containing one or more of these 22 drug substances without DMF registration will be banned beginning January 1, 2008. The KFDA recommended that companies submit applications for DMF filing by mid-February 2007 to meet this 2008 deadline.

To make the DMF filing process more manageable, the KFDA has set recommended submission dates for the 22 substances affected by the new KFDA regulations. Half were recommended for January 15-19, 2007 submission, while the remaining half were recommended for February 12-16, 2007 submission. These 22 substances include phenylephrine HCL, S-carboxymethyl cysteine, ofloxacin, diethylpropion HCL, and others.

Per Korean FDA guidelines, foreign manufacturers of these drug substances or products containing these substances can submit a DMF through a Korean importer or third-party representative with a Korean address. Domestic manufacturers can submit a DMF to the KFDA directly.

Once a DMF is submitted, the KFDA will review the documents and conduct a facility inspection. Most applications will need to undergo a facility inspection before getting approval. Once the application is approved, the KFDA will send a letter of acceptance and make public on its official website the names of the DMF sponsors and registered substances. The timeframe is approximately 5 months, though depending on the workload it can extend to 8-9 months.

A DMF will often contain confidential information on such items as facilities, materials, processes, and packaging. By submitting a DMF to the KFDA, the registered manufacturer can then refer importers or distributors to the registration number without disclosing confidential information to Korean business counterparts.