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 …

1 2I 3I 28 PMDA i ii iii iv v vi vii viii ix x xi xii xiii 4II 5II asean ACTD asean 1967 8 8 asean 10 asean asean asean asean

2 International Council for Harmonisationof technical Requirements for Pharmaceuticals for Human Use ICH ACTD PIC/S GMP WHO-GDP Good Distribution Practice WHO-GSP Good Storage Practice WHO-GPP Good Pharmacy Practice EU asean asean asean ACTD ACTD The asean common technical Dossier for the Registration of Pharmaceuticals for Human Use asean 2009 1 asean 2016 12 ACTD ICH-CTD common technical Document ACTD CTD ACTD Part I ACTD ACTD e-CTD 6II asean ACTD PART I Part I ACTD Certificate of a PhaermaceuticalProduct CPP Free Sales Certificate FSC)

3 Part I 3 Section PARTII PARTII ACTD PARTII Part II ICH-CTD MODULE 2 MODULE 3 ACTD Part II 4 Section PART III PART III GLP PART New Chemical Entity NCE asean PART III Section A D 4 Section SectionC D 4 4 Section SectionA SectionBACTD SectionC SectionA SectionB SectionC SectionD SectionA SectionB SectionC SectionD SectionE SectionF AppendixA 7II asean ACTD PART IV PART IV PART IV PART III PART III New Chemical Entity NCE asean Part IV Section A F 6 Part III SectionA SectionB SectionC

4 SectionD SectionE SectionF 8II MinistryofHealth MoH DepartmentofDrugsandFood DDF Ministry'sNationalLaboratoryforDrugQuali tyControl NLDQC OnTheManagementofPharmaceuticals,1996 2007 lawontheamendmentoflawonmanagementofphar maceutical,2007 asean 1 9II

5 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 2 1 2 1 2 1 1

6 2014 6 RACHA 2003 ODDID Version 2003 ODDID ODDID Version 2011 CV GMP 11II 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.

7 Prescription Only Medicine:POM 2. Pharmacy only medicine:P) 3. General Sale List Medicine:GSL 1. (Innovator product: NCE/biotech) 2. Generic Product 3. (Application for registerationof medicinal products via abridged route) Medicines Order,2007 33 1. 2. 13II Medicines Order, 2007 23 Medicines [Licensing, Standard Provisions and Fees] Regulations, 2010 Guide to Application for Registerationof Medical Products 3rd Edition(2012) Medicines Order, 2007 74 BDMCA National Adverse Drug MoniteringCenter.

8 NADRMC 2 Medicines [Licensing, Standard Provisions and Fees] Regulations, 2010 24 1 7 1 4 2013 1 Brunei Darussalam Guidelines on Reporting of Adverse Drug Reactions 14II GMP QMS Medicines Order, 2007 23 Guide to Application for Registerationof Medical Products 3rd Edition(2012) 27 Manufacture license 2010 BuruneiDarussalam Guidelines for Manufacturing and Handling of Halal Medicinal Products, Traditional Medicines and Health Suplements GMP GLP Guide to Application for Registerationof Medical Products 3rd Edition(2012) 27 ANNEX2 GUIDE ON SUBMISSION OF NON-CLINICAL DOCUMENTS (PART III) GCP Medicines Order, 2007 Guide to Application for Registerationof Medical Products 3rd Edition(2012) Guide to Application for Registerationof Medical Products 3rd Edition(2012) GUIDE ON SUBMISSION OF CLINICAL DOCUMENTS (PART IV)

9 Minor Variation Products Major Variation Products Clinical Summary Summary Clinical Study Reports SetionE Clinical Study Reports Major Variation Products Medicines Order, 2007 23