生命科学2025

Life Sciences2025 Definitive global law guides offeringcomparative analysis from top-ranked lawyers China: Law & PracticeAlan Zhou, Coco Fan,Kelly Cao and Stephanie WangGlobal Law Office CHINA Law and Practice Contributed by:Alan Zhou, Coco Fan, Kelly Cao and Stephanie WangGlobal Law Office Contents 1. Life Sciences Regulatory Frameworkp.6 1.1Legislation and Regulation for Pharmaceuticals and Medical Devices p.61.2Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation p.71.3DifferentCategoriesofPharmaceuticalsandMedicalDevicesp.7 2. Clinical Trialsp.7 2.1Regulation of Clinical Trials p.72.2Procedure for Securing Authorisation to Undertake a Clinical Trial p.82.3Public Availability of the Conduct of a Clinical Trial p.92.4Restriction on Using Online Tools to Support Clinical Trials p.92.5Use of Data Resulting From Clinical Trials p.92.6Databases Containing Personal or Sensitive Data p.10 3. Marketing Authorisations for Pharmaceuticals or Medical Devicesp.10 3.1ProductClassification:PharmaceuticalsorMedicalDevicesp.103.2Granting a Marketing Authorisation for Biologic Medicinal Products p.113.3Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices p.113.4Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices p.113.5Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations p.123.6MarketingAuthorisationsforPharmaceuticalsandMedicalDevices:OngoingObligationsp.133.7Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and MedicalDevices p.14 4. Regulatory Reliance and Fast Track Registration Routesp.14 4.1Fast Track Registration Routes p.144.2Regulatory Reliance p.15 5. Manufacturing of Pharmaceuticals and Medical Devicesp.155.1Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices p.15 6. Distribution of Pharmaceuticals and Medical Devicesp.16 6.1Wholesale of Pharmaceuticals and Medical Devices p.166.2DifferentClassificationsApplicabletoPharmaceuticalsp.17 CHINACONTENTS 7. Import and Export of Pharmaceuticals and Medical Devicesp.17 7.1Governing Law for the Import and Export of Pharmaceuticals and Medical Devicesand Relevant Enforcement Bodies p.177.2Importer of Record of Pharmaceuticals and Medical Devices p.187.3Prior Authorisations for the Import of Pharmaceuticals and Medical Devices p.187.4Non-TariffRegulationsandRestrictionsImposedUponImportsp.187.5Trade Blocs and Free Trade Agreements p.19 8. Pharmaceutical and Medical Device Pricing and Reimbursementp.19 8.1Price Control for Pharmaceuticals and Medical Devices p.198.2Price Levels of Pharmaceuticals or Medical Devices p.208.3PharmaceuticalsandMedicalDevices:ReimbursementFromPublicFundsp.208.4Cost-BenefitAnalysesforPharmaceuticalsandMedicalDevicesp.208.5Regulation of Prescriptions and Dispensing by Pharmacies p.20 CHINALaw aNd PraCTiCE Contributed by:Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang,Global Law Office Global Law Office(GLO) has become one ofthelargest,leadingChineselawfirms,withmore than 500 lawyers practising in its Bei-jing,Shanghai,ShenzhenandChengduof-fices. Its life sciences and healthcare practicegroup was one of the first in China and provides“one-stop”legal services for every area of theindustry, including M&A, investment and fund-ing, licence-in and out, daily operation, IP pro-tection, and advice on compliance, includinginternal and government investigations as well as anti-bribery matters and dispute settlement.Under a changing regulatory environment, thefirm’s team has the perfect combination of in-ternational experience and local knowledge tosupport various innovation or pilot projects, in-cluding digital healthcare and MAH/cMAH trialcases. The team participates in the formulationof local codes of conduct and benchmark poli-cies/rules and also co-operates closely with as-sociations such as the CPIA and the RDPAC. Authors Coco Fanis a partner in the lifesciences and healthcarepractice group at Global LawOffice and specialises incorporate, compliance, privateequity, venture capital and M&A. Alan Zhouis the leading partnerof the life sciences andhealthcare practice group atGlobal Law Office and has astrong background in the area,routinely representing multinational corporations, well-knownChinese state-owned and private enterprises,and private equity/venture capital funds. As aparticipant or an external counsel, he has beenengaged by local authorities and industrialassociations to advise on legislation andindustrial standards in the life sciences andhealthcare industry, including guidelines oncompliance and risk control, e-healthcare,medical insurance reform and medicalrepresentative administration. He has beenwidely published both at home and abroad. Her experience covers prescription medicine,over-the-counter medicine, contract researchorganisations, medical devices, biopharmaceuticals, hea