亚洲制药协会合作会议：2022年版PMRE亚洲药品市场与监管环境报告第一卷（英文版）（50页）.pdf

1、 Asia Partnership Conference of Pharmaceutical Associations(APAC)Pharmaceutical Market&Regulatory Environment in Asia（PMRE）ver.2022 Volume 1:Regulatory Environment Identification and Clarification of the Differences in Regulatory Environment between Asian Economies APAC PMRE Task Force April 5,2022

2、Tokyo,Japan Table of contents Page Abbreviation List-1 Executive Summary-5 Data sheets from each economy IND/CTA-8 NDA-14 Clinical Trials-29 Manufacturing-37 Post Approval-43 Acknowledgments-48 AbbreviationDescriptionACRAAccounting and Corporate Regulatory Authority(Singapore)ACTDASEAN Common Techni

3、cal DocumentADHDAttention Deficit Hyperactivity DisorderADMEAbsorption,Distribution,Metabolism and ExcretionADRAdverse Drug ReactionAEAdverse EventAEFIAdverse Event Folloing ImmunizationAFApplication FormAPIActive Pharmaceutical IngredientASEANAssociation of South-East Asian NationsASTTAdministratio

4、n of Science,Technology and TrainingAVGASEAN Variation GuidelineBABioavailabilityBEBioequivalenceBLABiologics License ApplicationBPBritish PharmacopoeiaBPOMBadan Pengawas Obat dan Makanan(Indonesian national agency of drug and food control)BSEBridging study evaluation(Taiwan)Cat.CategoryCDECenter fo

5、r Drug EvaluationCDFSCouncil on Drug and Food Sanitation(Japan)CDRRCenter for Drug Regulation and Research(Philippines)CDSCOCentral Drugs Standard Control Organization(India)CEPCertification of suitability to the monographs of the European PharmacopoeiaCFDAChina Food and Drug AdministrationCFDICente

6、r for Food and Drug InspectionChPChinese PharmacopoeiaChPCChinese Pharmacopoeia CommissionCIOMSCouncil for International Organizations of Medical SciencesCIRBCentralised Institutional Review Board(Taiwan）CLACentral Licensing Authority(India)CMCChemistry,Manufacturing and ControlCMOContract Manufactu