Regulations of Medicament Manufacturer Inspection｜第 5 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2014-02-21
For foreign manufacturers of imported pharmaceuticals mentioned in Subparagraph 1, Paragraph 1 of Article 3, the Taiwan agents (pharmaceutical companies) shall apply for inspection by submitting a fee, along with completed application materials and a Plant Master File (hereafter shortened to “PMF”) containing the items detailed in the application materials to the central competent health authority. However, for manufacturers of countries approved by the central competent health authority, the PMF may be replaced by the SMF and an inspection report from said country’s competent health authority. The PMF and SMF referred to in the preceding Paragraph shall be certified by the highest competent health authority or chamber of commerce in the country of origin. However, if documents from the highest competent health authority in the country of origin proving that the manufacturer is in compliance with local pharmaceutical GMP standards, or the original copy of a manufacturing and sales approval certificate clearly stating that said manufacturer is in compliance with local pharmaceutical GMP standards are submitted, the above certification is not required. If the country of origin is Germany, the documents may be issued by the competent health authority of a German state government, certification by the German federal government is not required. If inspection of foreign factory is required as part of the inspection mentioned in Paragraph 1, the applicant shall submit a fee to the central competent health authority, and coordinate with the foreign manufacturer in preparing the information required for the inspection process.