Taiwan FDA Proposes Regular Reporting for 584 Essential Medicines

Taiwan's Food and Drug Administration (FDA) is moving to bolster the nation's drug supply resilience by introducing new regulations that will mandate regular reporting of inventory and supply data for 584 essential medicines. The proposed measures, currently open for public comment, are expected to be finalized by the end of the year and implemented in 2025.

The new "Essential Medicines Reporting and Notification Measures" and "Drug Shortage Registration and Special Approval Manufacturing Import Measures" build upon existing requirements. Currently, drug manufacturers and importers must notify the FDA at least six months before a shortage occurs. The revised regulations introduce a proactive, systematic reporting mechanism based on risk assessment.

Under the proposed system, essential medicines will be categorized by risk level. Those identified as having a history of shortages, requiring close monitoring, or deemed critical will be subject to quarterly reporting. Companies will need to submit their current inventory levels, manufacturing, import, and supply status by the 15th of January, April, July, and October each year. For essential medicines without a history of shortages or those not requiring close monitoring, annual reporting will suffice, with submissions due by January 15th each year.

Failure to comply with these reporting requirements, including missing deadlines or providing inaccurate information, will carry significant consequences. The FDA reserves the right to publicly disclose the names, addresses, responsible persons, and drug details of non-compliant companies. Furthermore, repeat offenses or severe violations could lead to fines between NT$60,000 and NT$300,000 (approximately $1,800 to $9,000 USD). The FDA also emphasizes that even with these new measures, drug suppliers must still report potential shortages at least six months in advance.

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The draft will be open for public comment for two months, and we expect to finalize the announcement by the end of the year, with official implementation next year. At that time, based on risk classification, we will require companies to report inventory levels quarterly or annually.