钱伯斯：全球法律指南：生命科学2024之中国篇（中译版）（30页）.pdf

1、CHAMBERS GLOBAL PRACTICE GUIDESLife Sciences 2024Definitive global law guides offering comparative analysis from top-ranked lawyersChina:Law&Practice Alan Zhou,Coco Fan,Stephanie Wang and Kelly Cao Global Law OfficeCHINA2CHAMBERS.COMLaw and PracticeContributed by:Alan Zhou,Coco Fan,Stephanie Wang an

2、d Kelly Cao Global Law OfficeContents1.Life Sciences Regulatory Framework p.61.1 Legislation and Regulation for Pharmaceuticals and Medical Devices p.61.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation p.71.3 DifferentCategoriesofPharmaceutical

3、sandMedicalDevicesp.72.Clinical Trials p.72.1 Regulation of Clinical Trials p.72.2 Procedure for Securing Authorisation to Undertake a Clinical Trial p.82.3 Public Availability of the Conduct of a Clinical Trial p.92.4 Restriction on Using Online Tools to Support Clinical Trials p.92.5 Use of Data R

4、esulting From Clinical Trials p.92.6 Databases Containing Personal or Sensitive Data p.93.Marketing Authorisations for Pharmaceuticals or Medical Devices p.103.1 ProductClassification:PharmaceuticalsorMedicalDevicesp.103.2 GrantingaMarketingAuthorisationforBiologicMedicinalProductsp.103.3 PeriodofVa

5、lidityforMarketingAuthorisationforPharmaceuticalsorMedicalDevicesp.103.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices p.113.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations p.123.6 MarketingAuthorisationsforPharmaceuticalsa

6、ndMedicalDevices:OngoingObligationsp.133.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices p.133.8 Rules Against Illegal Medicines and/or Medical Devices p.143.9 Border Measures to Tackle Counterfeit Pharmaceuticals and Medical Devices