Korea is Pressing Forward on CMC/GMP Harmonization Quest

South Korea’s quest to more closely harmonize its CMC and GMP quality regulatory processes with ICH/global norms is creating openings for outside companies and regulators to work with the Korean FDA (KFDA) to resolve remaining differences.

This opportunity was highlighted by Lilly Global Regulatory CMC Director Jeffrey Ferguson in addressing quality regulatory developments in Korea at the ISPE annual meeting in Orlando, Florida in November.  Ferguson addressed a session of the meeting at which ISPE’s recently-formed Asia Pacific Focus Group (APFG) shared its knowledge about and experience with CMC/GMP developments across the Asia Pacific region.

Korea is in a “state of change” and is “open to a continuous set of legislative efforts to make sure that it is able to support regulatory harmonization with the rest of the world,” the Lilly official commented.  In turn, this desire to harmonize is an opportunity for outside companies and regulators “to influence where there are still some differences between Korea and the rest of the world.”

KFDA’s harmonization objective is evidenced by its active participation in ICH’s Global Cooperation Group (GCG), the Asia Pacific Economic Cooperation (APEC) and joint meetings with China and Japan.  The agency’s goal, Ferguson said, is to learn what the current standards are and to compare them with its own regulatory processes to see where changes may be needed.

KFDA will also be applying soon to join the Pharmaceutical Inspection Cooperation Scheme (PIC/S).  Asia Pacific countries Malaysia and Singapore are already members, and Indonesia and Thailand have applied (IPQ “In the News” Dec. 20, 2010).

[Korea’s progress toward international conformity on the CMC/review and GMP/inspection fronts is analyzed for subscribers hereNon-subscribers can purchase the full story for $95 by contacting Jonathan Trethowan (Jonathan@ipq.org).  For subscription information, click here.]