Korea to Reorganize KFDA

The Korea Food and Drug Administration (KFDA) is undergoing some reorganization. In his second year at his post, Commissioner Yun Yeo-pyo has decided to restructure the KFDA to improve its efficiency and oversight of food, drug, and medical device safety.

New divisions of the KFDA will include a Risk Prevention Policy Bureau and a Risk Violation Central Investigation Agency. The Risk Prevention Policy Bureau will be established to focus more resources on preventing incidents before they occur. The new bureau is planned to have 45 employees. The Risk Violation Central Investigation Agency will be established to strengthen post-marketing surveillance and response. This agency will conduct criminal investigations of manufacturers that undertake illegal and unsafe practices in food, drug, and medical device production or distribution. The agency will have the authority to penalize such manufacturers. The new agency will have about 80 employees, which include 20 stationed at the main office and 10 at each of 6 local KFDA offices.

Several functions previously handled by the KFDA main office, including those of GMP evaluation, will now be taken over by the local KFDA offices so that the main office may concentrate on policy and safety. The local offices will be restructured to execute these nation-wide tasks. Their simpler duties will be transferred to the local governments.

Standards for promotion and hire have also been increased, and a budget of 2.9 billion won (approximately USD$2.1 million) was approved for improved personnel management. This budget will allow the KFDA to hire about 40 new professionals in 2009, which should improve registration review time and efficiency.