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Taiwan has successfully been included in the list of third countries for APIs, indicative of the regulatory system recognized by the European Union

【Update Date:2023-11-29unit:品質監督管理組

Taiwan has been included in the list of third countries by the European Commission (EC), signifying that our regulatory system for active pharmaceutical ingredients (APIs), encompassing manufacturing, quality systems, and GMP standards, is recognized as equivalent to European requirements. This inclusion aims to expedite the timeline for the entry of APIs into the EU market, thereby bolstering the global competitiveness of Taiwan's pharmaceutical manufacturers.

The Taiwan Food and Drug Administration (TFDA) submitted its application to be included in the list of third countries on 8 December 2021. Following a review of the relevant documents, the European Commission conducted an on-site audit from April 20 to 27 this year. The audit team, consisting of one auditor from the EC and one from an EU member state, engaged in a comprehensive assessment, which included documentary review and personnel interviews with TFDA to grasp the design of the regulatory control system in place and scrutinize its actual implementation. The audit team also visited two API manufacturers in Taiwan to witness their inspection performance. Impressed by TFDA's performance, the audit team reached a positive conclusion, affirming that the Taiwanese system can be considered equivalent to the EU. After several months of internal procedures, the European Union officially announced on 10 November that Taiwan has been included in the list of third countries.

According to EC regulations, starting from July 2013, imported APIs from countries outside the EU must be accompanied by a "Written Confirmation" from the competent authorities of the exporting third countries. This confirmation verifies that the APIs were manufactured under control and enforcement of good manufacturing practices equivalent to those in the EU. The only exception is for APIs imported from countries already on the list of third countries. Presently, nine countries, including Taiwan, Canada, South Korea, Australia, Brazil, Israel, Japan, Switzerland, and the US, have successfully been added to this list.