中华人民共和国医药行业标准 - glo.com.cn

1 ICSCCS PIAC/T00001-2020 Pharmaceuticalindustrycompliancemanageme ntpractices2020-12-31 2021-02-26 IPIAC/T00001-2020 IIPIAC/T00001-2020 1 PIAC/T00001-2020 1.

2 1 2 PIAC/T00001-20202. 2020 2021 MAH 1 MAH CRO CMO CDMO CSO 3 2 MAH CRO CMO CDMO CSO

3 4 PIAC/T00001-20203. :2014GB/T51116-2016 2019 1 9 2019 1 2018 11 2 2018 106 2018 12 26 2018 1916 2018 12 28 2018 464 SZDB/Z245-2017 4. Compliance ComplianceRisk ComplianceManagement ComplianceManagementAssessmentAreas 8 5 PIAC/T00001-2020 ComplianceRiskIndicator

4 KeyComplianceRiskIndicator Non-keyComplianceRiskIndicator PharmaceuticalProduct MedicalDevice a) b) c) d) e) f) PharmaceuticalandMedicalDeviceProduct PharmaceuticalandMedicalDeviceEnterprise / MAH / CRO / CMO CDMO / CSO / MarketAuthorizationHolder/MAH 6 PIAC/T00001-2020 PharmaceuticalandMedicalDeviceProductMan ufacturingEnterprise

5 DomesticAgencyofaForeignMarketAuthorizat ionHolder / / PharmaceuticalandMedicalDeviceProductDis tributingEnterprise / ContractResearchOrganization/CRO / ContractManufacturingOrganization/CMO / ContractDevelopmentandManufacturingOrgan ization/CDMO / ContractSalesOrganization/CSO / / / HealthcareProfessionals/HCP HealthcareOrganization/HCO / 7 PIAC/T00001-20205.

6 A B C D E F G H I J 6. - - - 8 PIAC/T00001-2020 2 CEO 9 PIAC/T00001-2020 3

7 A) 1) 2) 3) 4) 5) 6) 7) 8) 9) b) 1) 2) 3) 4) 5) 6) 7) 10 PIAC/T00001-2020c) 1) 2) 3) 4) 5) a) b) c)

8 11 PIAC/T00001-2020d) a) b) c) a) b) 1)

9 12 PIAC/T00001-2020 4 2) 3) c) 5 13 PIAC/T00001-2020d) 1) 2) 3) 4) a) b) c) d)

10 14 PIAC/T00001-2020 6 a)