Mandatory reporting of market supply suspended drugs

MFDS give an administrative notice on revision to the reporting criteria for

New criteria have been established for reporting drug shortages due to reduced production·importation

The mandatory reporting is being considered to include drug products of suspended production·importation and supply, and 'supply shortage drugs' of which supply has been halted for more than 1 month.

 

The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) stated that it would announce on March 11 an administrative notice of revision to the 'Regulation on Notification of Production·Importation·Supply suspended drug products' and will receive opinions until March 31.

 

The regulation concerns the notification criteria for pharmaceutical companies reporting a supply shortage of drug products.

 

The revision details include reducing the time for reporting the discontinuance of production, importation, and supply of drug products from 60 days in advance to 180 days in advance, and it establishes a new duty to report on production and importation shortage.

 

The MFDS has established criteria for production·importation shortage to address the issue of lack of definition of drugs sold out and drugs in supply shortage.

 

Revision (draft) to the

According to the MFDS' criteria for reporting drug supply shortages due to reduced production·importation, two types have been set as ▲A decrease in production·import volume to less than half of the three-year annual average over the next one year ▲A decrease in supply or supply suspension, including a temporary halt in production·imports for at least three months or a market supply suspension for more than one month.

 

In the case of supply reduction, if production or imports are expected to decrease to 50% or less of the three-year annual average for the upcoming one year as of the end of each quarter, a report must be submitted to the MFDS within one month of the quarter's end.

 

Suppose production or imports are expected to be suspended for more than three months, and market supply is expected to be halted for over one month.

 

In that case, a supply reduction plan must be established and reported within one month.

 

However, if the temporary suspension of production·imports·supply is extended and meets the reporting criteria, the revised plan must be reported within 10 days of the change.

 

Supply reduction and temporary supply suspension are excluded from reporting requirements in cases where ▲Temporary suspension or reduction of production·import occurs before the designation of a reportable item ▲Temporary suspension or reduction occurs naturally due to decreased market demand, or only specific packaging units are affected without significant disruption to the overall drug supply ▲Manufacturing·import·sales suspensions resulting from administrative sanctions.

 

Additionally, reporting on temporary supply suspensions is exempt ▲If the product has been on the market for less than three years after approval or has been produced·imported two or fewer times in the past three years ▲If the company holds inventory equivalent to its quarterly production or import volume for the past year and faces no difficulty in market supply.

 

Additionally, as previously announced by the MFDS, the revised regulations now require companies to report supply discontinuation 180 days in advance, moving up the reporting timeline from the previous 60 days.

 

For permanent·temporary discontinuation of drug production·import·supply due to reasons such as withdrawal of product approval or contract termination, companies must report at least 180 days before the scheduled discontinuation date.

 

Along with enhanced reporting duty, administrative penalties have also been revised.

 

If a company reports supply discontinuation between 180 days before the discontinuation date and the actual discontinuation date, the first violation will result in a 7-day suspension of manufacturing operations.

 

A second violation will lead to a 15-day suspension, a third violation will result in a 1-month suspension, and a fourth violation will incur a 3-month suspension of manufacturing operations.

 

Failure to report production reduction will also result in penalties.

 

A first violation will result in a warning, a second violation will lead to a 15-day suspension, a third violation will result in a 1-month suspension, and a fourth violation will lead to a 3-month suspension of manufacturing operations.