Food and drug safety ministry proposes simpler drug change procedures

The food and drug safety ministry said it would simplify minor-change procedures for pharmaceutical businesses to reduce administrative burdens, letting address updates after administrative boundary reorganizations be settled through reporting rather than through change permits, notifications, approvals or designations.

Public comments on the draft, announced Aug. 21, will be accepted through Oct. 21. The ministry said it expects the revisions to "lay the foundation" for stronger drug quality and safety management.

The ministry wants to classify location changes tied to redrawn administrative boundaries as minor for drug manufacturers, importers, contract manufacturing and sales businesses, as well as clinical-trial plans and clinical-sample analysis and nonclinical research organizations. The proposed rules would allow the matter to be settled by a report submitted within one year, instead of requiring change permits, notifications, approvals or designations.

The revision would shorten the statutory processing period for clinical-trial plans and amendments that receive a suitable preliminary review to 10 days from 30 days. A recall plan would also need to be submitted within three days, compared with five days under the current rule, when medicines already circulating in South Korea raise safety or efficacy concerns.

Manufacturing and quality-control standards for investigational drugs would be revised in line with changes to the Good Manufacturing Practice guidelines of the Pharmaceutical Inspection Co-operation Scheme. The draft would also prohibit advertisements that use artificial intelligence systems in ways that could mislead doctors and other experts.