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TFDA Reinforces Commitment to Ensuring Safety and Quality of imported Pharmaceuticals

【Update Date:2023-06-29unit:品質監督管理組

As technology advances and markets globalize, and with increasing demands from consumers for the safety and quality of medicinal products, Taiwan has fully implemented the international PIC/S GMP standards to ensure the quality of medicinal products. For foreign pharmaceutical manufacturers exporting medicinal products to Taiwan, the Taiwan Food and Drug Administration (TFDA) dispatches inspectors to conduct on-site inspections or review documents to verify their compliance with GMP standards. Additionally, as a Participating Authority of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), TFDA can share information with other members. This includes sharing information on quality defects of medicinal products or non-compliance with GMP through the PIC/S Rapid Alert and Recall System. This enables immediate assessment of the impact and allows for prompt measures to address any potential risks.

The TFDA emphasizes its commitment to ensuring that the public has access to pharmaceutical products of equivalent quality to those found in advanced countries. It will continue to enhance the management of foreign pharmaceutical manufacturers, monitor international non-compliance with GMP issues and alerts, and take immediate actions to ensure the safety of medication for the Taiwanese public. The TFDA strives to achieve the goal of guaranteeing the safety and quality of pharmaceuticals.