Report on Drug Supply Disruption, Advance Notification from 60 Days to 180 Days Earlier

Administrative Notice Issued for Revision of Reporting Regulations
on Production, Import, and Supply Interruption of Pharmaceuticals

The reporting timeline for supply interruptions of finished pharmaceutical products produced by pharmaceutical companies will be moved forward from 60 days to 180 days in advance.

The Ministry of Food and Drug Safety announced on the 12th that it has issued an administrative notice for the revision of the "Regulations on Reporting of Production, Import, and Supply Interruption of Pharmaceuticals," which sets the reporting standards for supply shortages of finished pharmaceutical products by pharmaceutical companies. Comments will be accepted until the 31st.

The revision was prepared to stipulate matters delegated by the Prime Minister's decree following the amendment of the "Pharmaceutical Affairs Safety Rules" in October last year and to reflect other necessary adjustments.

The main points include ▲ reflecting the amendment of the Prime Minister's decree such as changing the supply interruption reporting timeline (from 60 days to 180 days in advance) ▲ establishing criteria for production and import reduction that trigger supply shortage reporting ▲ clarifying the scope and exceptions for supply interruption and shortage reporting.

The criteria for supply shortage reporting are defined as cases where the production or import volume for the upcoming year decreases to less than half compared to the average annual volume over the past three years, or when production or import is temporarily suspended for more than three months and market supply is temporarily suspended for more than one month.

Detailed information can be found on the Ministry of Food and Drug Safety website under 'Laws/Materials → Legal Information → Legislative/Administrative Notice.'

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