Transcription of 平成29年度 アジア諸国医薬品・医療機器規制情報収集・分析 …
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5 DepartmentofDrugsandFood DDF Ministry'sNationalLaboratoryforDrugQuali tyControl NLDQC OnTheManagementofPharmaceuticals,1996 2007 lawontheamendmentoflawonmanagementofphar maceutical,2007 asean 1
6 9II Guideline for adverse Drug Reactions Monitoring and related matters 2012 GMP QMS GMP the Law on the Management of Quality and Safety of Products and Services 10II GCP the National Institute of Public Health the National Ethics Committee for Health Research
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8 GLP 12II Ministry of Health MoH Department of Pharmaceutical Services DPS Drug Administration Section DAS Drug Registration Unit DRU Brunei Darussalam Medicines Control Authority BDMCA Medical Product Medicines Order,2007 4 Guide to Application for Registerationof Medical Products 3rd Edition(2012) 3 1.
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