Korea: More Effort Placed on Pharmaceutical Safety and Quality

In May 2005, a Memorandum of Understanding was signed by members of the World Health Organization (WHO), Korea Ministry of Health and Welfare (MOHW) and Korea Food and Drug Administration (KFDA), as a means of cooperating on chemical safety activities. Under the MOU, Korea will participate in the International Program on Chemical Safety (IPCS), a global program established to ensure chemical safety and regulate the levels of harmful chemicals in pharmaceuticals, foods, cosmetics, and other products. In particular, the KFDA hopes that their new membership in the IPCS will help increase the competitiveness of the Korean pharmaceutical market, currently valued at over $6 billion.

The IPCS chemical safety program will be regulated by the KFDA in collaboration with Korea National Institute of Toxicological Research and the Korea Occupational Safety and Health Agency. Some of the areas these three agencies will focus on include: (1) chemical risk management, (2) establishment of standard methodology to evaluate quality guidelines for pharmaceuticals and foods, and (3) harmful chemical prevention, through the collection of human toxicology data.

In June 2005, the KFDA also announced plans to create a National Center for Risk Analysis, a division of the KFDA which will assist with the IPCS chemical safety program. Membership in the IPCS is expected to boost Korea cooperation with international organizations in the areas of food, drugs, and cosmetics.