MFDS "New Guidelines Adopted at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals General Assembly"

[Asia Economy Reporter Byeon Seon-jin] The Ministry of Food and Drug Safety announced on the 24th that a new guideline was approved at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) biannual general meeting held over two days from the 15th to the 16th in Incheon. Established in 1990, the ICH is an international cooperative organization leading the international harmonization of standards related to pharmaceutical quality, safety, and efficacy.

At this meeting, the ICH guideline Q13, which provides scientific regulatory considerations for the development, implementation, and lifecycle management of continuous manufacturing processes for drug substances and drug products, was approved. The Ministry of Food and Drug Safety plans to promote the prompt implementation of the Q13 guideline domestically.

Additionally, the ICH Contribution Award was presented to 12 experts who led the ICH expert committee and contributed to international harmonization of pharmaceuticals.

They also shared updates on the use and translation status of the Medical Dictionary for Regulatory Activities (MedDRA). MedDRA, currently used by over 8,200 organizations in 134 countries, has completed translations into Greek and Polish, and Arabic translation is underway.

A Ministry of Food and Drug Safety official stated, "We will continue to actively participate in ICH activities to ensure that the domestic pharmaceutical regulatory environment reflects international standards."

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