USP forges closer ties with South Korean FDA
The memorandum of understanding (MOU) is similar to those the USP has with various regional drug regulators around the world and will focus on information sharing, training and the establishment of mutually-agreed reference standards to ensure the quality of
Potential areas of collaboration include annual scientific meetings and workshops, the development of standards, joint education and training programmes on compendial procedures and the direct exchange of scientific expertise.
This process actually started in December last year when three scientists from the KFD worked at the USP’s HQ in Rockville, Maryland to experience how the organisation operates, particularly in terms of its quality management structure and reference standard development process.
USP CEO Roger Williams stressed the importance of such collaborations at the MOU signing ceremony in the South Korean capital Seoul.
“The global pharmaceutical community is inextricably connected, making arrangements like this important to both countries,” he said, adding that “KFDA and USP have already engaged in a number of mutually beneficial activities, providing each organisation with an in-depth knowledge of how the other operates.”
This was echoed by KFDA commissioner Hee-Sung Lee, who said: “I hope to exchange experience and establish mutual trust to facilitate the pharmaceutical trade between the two countries.”
KORUS of approval?
The siging of the MOU follows just over a month after the US and South Korean' Governments agreed a new free trade agreement that – despite some significant drug industry reservations about reimbursement, notably from PhRMA – is likely to see more US made drugs sold in South Korea.
This is certainly the view of the Officer of the United States Trade Representative who said the agreement – certified on March 15 – "makes sure that American manufacturers of medicines and medical devices are able to compete in South Korea, based on fair, predictable, and understandable rules and regulations.”
