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Medicines manufacturers

Routine Assessment

【Update Date:2015-10-06】 unit:品質監督管理組
 
I:Administration of Overseas Plants
   Based on the consistent regulations of domestic and overseas pharmaceutical manufacturers, Ministry of Health and Welfare promotes the ongoing managements of overseas pharmaceutical manufacturers in order to ensure the quality of input medicines. According to Regulations of Medicament Manufacturer Inspection, the follow-up inspections of foreign pharmaceutical manufacturers of imported drugs shall be conducted every two years and may extend one to two years depending on the management system and standards for pharmaceutical manufacturing in country of origin which is according to Regulations of Medicament Manufacturer Inspection.
 
II:Legal Basis
1.Pharmaceutical Affairs Law (PAL), Article 57.
2.Pharmaceutical Manufacturer Inspection Measures, Article 9.
 
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.