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Medicines manufacturers

New Application

【Update Date:2015-10-06】 unit:品質監督管理組
I:Administration of Overseas Plants
     Taiwan has required that pharmaceutical manufacturers submit relevant basic (overseas) plant data as part of registration procedures for pharmaceutical products submitted for license approval review since 1976. From 1988, with the implementation in Taiwan of the Good Manufacturing Practice (GMP) system, all overseas pharmaceutical manufacturers applying for approval to import pharmaceuticals into Taiwan have been required to submit their Plant Master Files (PMFs) for review and approval.
     Procedures were revised further in June 2002 to incorporate the 3-stage validation process already required of domestic pharmaceutical plants as well as to permit plants overseas to request a Department of Health (DOH) on-site inspection in lieu of submitting relevant validation documentation. Henceforth, the approval process for overseas pharmaceutical plants could follow one of two tracks – the first focused on review and approval of required documents and the other focused on actual on-site inspection and approval of said plants.
 
II:Legal Basis
1.Pharmaceutical Affairs Law (PAL), Article 57.
2.Pharmaceutical Manufacturer Inspection Measures, Article 3 and 5.
3.Standards for Medicament Factory Establishments
4.PIC/S Guide to Good Manufacturing Practice for Medicinal Products 
 
III:Dual Tracks
          In order to bolster the legal basis for plant inspections overseas, December 2004 revisions to the “Regulations of Pharmaceutical Manufacturer Inspection” specified that, for all plant approval applications involving overseas pharmaceutical manufacturers, local agents or subsidiaries of the manufacturer needed to fill out relevant application forms, pay relevant fees, prepare relevant PMF information on overseas plants and submit completed applications to the TFDA.
New application