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Definitive global law guides offering China: Law and PracticeAlan Zhou, Coco Fan, Kelly Cao,Stephanie Wang and Rae ZhangGlobal Law Office CHINA Law and Practice Contributed by:Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae ZhangGlobal Law Office Contents 1. Life Sciences Regulatory Framework 5. Manufacturing of Pharmaceuticals and MedicalDevicesp.135.1Requirement for Authorisation for ManufacturingPlants p.13 1.1Legislation and Regulation p.51.2Challenging Decisions of Regulatory Bodies p.61.3Categories of Pharmaceuticals and Medical Devices p.6 6. Distribution of Pharmaceuticals and MedicalDevicesp.136.1Wholesale of Pharmaceuticals and Medical Devices p.136.2DifferentClassificationsApplicabletoPharmaceuticalsp.14 2. Clinical Trialsp.6 2.1Regulation of Clinical Trials p.62.2Securing Authorisation to Undertake a Clinical Trial p.72.3Public Availability of the Conduct of a Clinical Trial p.72.4Use of Online Tools to Support Clinical Trials p.72.5Use of Data From Clinical Trials p.8 7. Import and Export of Pharmaceuticals andMedical Devicesp.14 7.1Governing Law and Relevant Enforcement Bodies p.147.2Importer of Record of Pharmaceuticals and MedicalDevices p.157.3Prior Authorisations for the Import of Pharmaceuticalsand Medical Devices p.15 3. Marketing Authorisations 3.1ProductClassificationp.83.2Marketing Authorisation for Biologic Medicinal Products p.93.3Period of Validity of Marketing Authorisations p.93.4Procedure for Obtaining a Marketing Authorisation p.93.5Access to Pharmaceuticals and Medical DevicesWithout Marketing Authorisations p.10 8. Pharmaceutical and Medical Device Pricing andReimbursementp.16 8.1Price Control for Pharmaceuticals and MedicalDevices p.168.2Price Levels of Pharmaceuticals or Medical Devices p.168.3Reimbursement From Public Funds p.178.4Cost-BenefitAnalysesp.17 4. Regulatory Reliance and Fast-Track RegistrationRoutesp.12 4.1Fast-Track Registration Routes p.124.2Regulatory Reliance p.12 CHINALaw and Practice Contributed by:Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang,Global Law Office Global Law Office(GLO) has become one of the larg-est, leading Chinese law firms, with more than 500lawyers practising in its Beijing, Shanghai, Shenzhenand Chengdu offices. Its life sciences and health-care practice group was one of the first in China andprovides “one-stop” legal services for every area of matters and dispute settlement). Under a changingregulatory environment, the firm’s team has the per-fect combination of international experience and lo-cal knowledge to support various innovation or pilotprojects, including digital healthcare and MAH/cMAH Authors Kelly Caois a partner in the lifesciences and healthcare practicegroup at Global Law Office. Her mainpractice areas encompass dispute Alan Zhouis the leading partner ofthe life sciences and healthcarepractice group at Global Law Officeand has a strong background in the known Chinese 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 and industrial employment. Ms Cao has advised major lifesciences companies on general compliance anddispute resolution, and assists multinationalenterprises and well-known domestic enterprises Stephanie Wangis an of counsel inthe life sciences and healthcarepractice group at Global Law Officeand has more than ten years’ Coco Fanis a partner in the lifesciences and healthcare practicegroup at Global Law Office,specialising in corporate, compliance, pharmaceutical and medtech companies on theircorporate governance, daily operations andcompliance. She has extensive knowledge andexperience in the life sciences and healthcareindustry, and routinely advises clients on a variety of L&H practice includes prescription medicine,over-the-counter medicine, contract researchorganisations, medical devices, biopharmaceuticals,health foods, clinical supply, vaccines, animal healthand hospitals. Ms Fan has advised manymultinational companies, private companies and CHINALaw and Practice Contributed by:Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang,Global Law Office Rae Zhangis an of counsel in the lifesciences and healthcare practicegroup at Global Law Office andspecialises in life science and and ESG. She is the legal counsel of manymultinational and biotech companies in MainlandChina, including Boehringer Ingelheim, Sanofi, MSD,GSK, Novartis, Daiichi Sankyo, Medtronic, Zai Lab,Nhwa, Gensci, Jemincare, etc. She has rich legaland regulatory compliance experience in the Global Law Office 36th Floor, Shanghai One ICCNo 999 Middle Huai Hai RoadXuhui District Tel: +86 21 2310 8200Fax: +86 21 2310 8299Email: Alanzhou@glo.com.cnWeb: www.glo.com.cn CHINALaw and Practice Contributed by:Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang,Global Law Office 1. Life Sciences Regulatory Framework