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Accession of Taiwan FDA to PIC/S- Providing a major boost to the Taiwan pharmaceutical industry

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2017-07-11
  • Last Updated:2017-07-11

Taiwan Food and Drug Administration (TFDA) has become a member of The Pharmaceutical Inspection Co-operation Scheme (PIC/S) since January 1, 2013. A membership in PIC/S demonstrates that Taiwan regulatory framework of manufacturing medicinal products including the legislation, GMP standards, inspection resources and quality management systems has been accredited by the PIC/S against the international standards and norms. Being a full PIC/S Participating Authority is really inspiring for both TFDA and pharmaceutical industries in Taiwan, the GMP certificates and inspection results issued by TFDA could be recognized globally. In addition, all pharmaceutical manufacturers engaged in the manufacture of medicinal products have fully complied with PIC/S GMP. Both these achievements also sharpen Taiwan pharmaceutical manufacturers global competitiveness.

PIC/S is an official international organization presently comprises 49 Participating Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products coming from all over the world (Europe, Africa, America, Asia and Australasia). It leads the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates and other international affairs.

TFDA submitted PIC/S membership application in June 2010 and underwent a series of rigorous assessment process, which included dossier assessment and on-site visit. During the assessment, 89 indicators were satisfied by PIC/S, including regulatory directives and policies, quality management system, inspection resources, alert and crisis systems etc. The Pharmaceutical Affair Act had been amended to specify that all pharmaceutical manufacturers engaged in the manufacture of medicinal products in Taiwan must be in compliance with PIC/S GMP. After 2 years and 6 months' efforts, TFDA became PIC/S 43th official participating authority as from 1 January 2013 (6th in Asia-Pacific, ahead of Japan and Korea).

Through PIC/S platform, we could share information with other members, including quality defects of medicinal products by PIC/S Rapid Alert and Recall System, participate inspector training activities and harmonize the inspection procedures and quality system in the field of GMP with international standards, facilitate co-operation and networking with other members, thus increasing the mutual confidence and further to voluntary sharing of GMP reports or recognition of GMP Certificates.