REFERENCE CODE GDHC0080CHR PUBLICATION DATE JUNE 2015 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE REPUBLIC OF CHINA (TAIWAN)

Transcription

1 REFERENCE CODE GDHC0080CHR PUBLICATION DATE JUNE 2015 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE

2 Executive Summary An increasingly elderly population and a declining birth rate pose a demographic challenge for the government. Good access to health insurance, a growing healthcare burden and government initiatives are expected to drive market growth, although periodic price cuts have presented a major challenge. In 2013, the number of people above the age of XX accounted for XX% of the population of Taiwan (officially the Republic of China) (NDC, 2014a). It is increasing significantly, and this will increase the disease burden. Medical expenditure for chronic diseases has also increased, although the government is attempting to reduce the financial burden through comprehensive healthcare reforms. The overall population increased slightly between 2008 and 2013 from XX to XX million, mainly due to a rising life expectancy. However, the birth rate decreased at a negative Compound Annual Growth Rate (CAGR) of XX% between 2008 and 2013 (NDC, 2014a). Although, at $XX billion, Taiwan s pharmaceutical market was smaller than those of Japan, China, India and South Korea, in 2013, its per-capita expenditure on medicines was significantly higher, at $XX. The pharmaceutical market grew at a CAGR of XX% from 2008 to The government is taking various steps to ensure investment in and the growth of the pharmaceutical industry. According to the Act for the Development of Biotech and New Pharmaceuticals Industry, the government is providing incentives for new pharmaceutical companies, such as reductions in income tax. The Global Budget Payment System was implemented in 2002, since which the price of National Health Insurance (NHI)-funded drugs has been reduced seven times, impacting both domestic companies and their foreign counterparts. The last price cut took place in 2011 and led to price cuts on XX drugs amounting to $XXm. The Ministry of Health and Welfare (MoHW) introduced the Drug Expenditure System in 2013 on a trial basis. According to this system, prices would be adjusted, based on the deficits caused by the difference between the healthcare budget and the actual spending. If the actual spending for a particular year were more than the healthcare budget, a price cut would be brought into effect the following year. In 2014, there was a deficit of TWDXX billion ($XXm) that resulted in a price cut on XX drugs at an average cut rate of XX%. This went into effect in April 2015 (IRPMA, 2013). Pharmaceutical prices in Taiwan are on average approximately XX% of the price of the original industry developed products marketed in the US (USTR, 2013). The continual price cuts are a major challenge for the growth of the pharmaceutical market. 2

3 Executive Summary Pharmaceutical Market, Taiwan, Revenue ($bn), Medical Device Market, Taiwan, Revenue ($bn), Revenue ($bn) Revenue ($m) Source: Chen, 2010; MOEAIDB, Source: GlobalData, Medical etrack [Accessed on April 26, 2015] The Taiwanese market for medical devices is one of the largest in Asia due to the growing elderly population and consequent increase in the demand for healthcare products and services. It was valued at approximately $XX billion in 2008 and grew at a CAGR of XX% to $XX billion in By 2020, it is expected to have reached $XX billion. Universal healthcare coverage and access to healthcare facilities and reimbursement are the distinguishing features of the healthcare system. Taiwan has a compulsory NHI system with universal coverage: approximately XX% of the population (NHI, 2014a). The second-generation NHI system was implemented in January 2013, and in July 2013, the name Bureau of NHI (BNHI) was changed to National Health Insurance Administration (NHIA). Owing to the reforms in the NHIA system, the NHIA no longer has a deficit in funding (NHI, 2014a). In 2013, approximately XX% of all healthcare facilities were contracted by the NHI system. The government receives funds for health insurance from general tax revenue. 3

4 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction GlobalData Report Guidance Overview of Pharmaceutical and Medical Device Markets Pharmaceutical Market Market Overview Pharmaceutical Exports and Imports Supply Channels Market Segments Overview of Top Five Disease Areas Major Players Medical Device Market Market Overview Overview of Top Five Segments Diagnostic market Major Players Market Drivers and Barriers Drivers Barriers

5 Table of Contents 4 Market Access Reimbursement and Payer Landscape Overview of Healthcare System Reimbursement Process Overview of Insurance Providers Patient Share in Healthcare Spending Price Trend in Healthcare Services Pricing Policies Regulatory Landscape Overview of Regulatory Agencies Market Authorization Procedure for Pharmaceutical Products Market Authorization Procedure for Medical Devices Licensing Process for Pharmaceutical and Medical Device Manufacturing Licensing Process for Pharmaceutical Exports and Imports Intellectual Property Rights Clinical Trial Regulations Pharmaceutical Advertising Regulations Pharmacy Regulations Labeling and Packaging Regulations Country Analysis Political Environment Political Structure Analysis of the Current Political Environment

6 Table of Contents Healthcare Policy Initiatives Economic Landscape Economic Indicators Gross Domestic Product National Income per Capita Inflation Currency Exchange Rate Foreign Direct Investment Foreign Exchange Reserves Trade Balance Government Structural Balance General Government Gross Debt Major Industries Demographics Population Education and Literacy Employment Disease Burden Healthcare Infrastructure Healthcare Facilities Healthcare Parameters Environmental Health Healthcare Personnel

7 Table of Contents 5.6 Healthcare Expenditure Overview Major Components of Healthcare Spending Public and Private Sector Share Spending in Pharmaceutical Research and Development Trade Associations Taiwan Medical and Biotech Industry Association Taiwan Public Health Association Taiwan Medical Association Taiwan Generic Pharmaceutical Association Trade Fairs Opportunities and Challenges Opportunities Challenges Appendix Abbreviations Bibliography Research Methodology Coverage Secondary Research Forecasts Expert Panel Disclaimer

8 Table of Contents 1.1 List of Tables Table 1: Pharmaceutical Market, Taiwan, Revenue ($bn), Table 2: Pharmaceutical Market, Taiwan, Revenue Forecast ($bn), Table 3: Pharmaceutical Market, Taiwan, Exports and Imports ($bn), Table 4: Table 5: Pharmaceutical Device Market, Taiwan, Market Segments of Newly Emerging Biotech Industry by Share (%), Pharmaceutical Device Market, Taiwan, Top Five Therapeutic Areas by Expenditure on Personal Health Care, Table 6: Pfizer, Global, Major Products, Revenue, Table 7: Pharmaceutical Market, Global, Late-Stage Pipeline, Pfizer, Table 8: Sanofi, Global, Major Products, Revenue ($m), Table 9: Sanofi, Global, Late-stage Pipeline, Table 10: GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%), Table 11: Pharmaceutical Market, Global, Late-Stage Pipeline, GlaxoSmithKline, Table 12: Major Products, China Chemical and Pharmaceutical Co., Table 13: Medical Device Market, Taiwan, Revenue ($bn), Table 14: Medical Device Market, Taiwan, Revenue Forecast ($bn), Table 15: Medical Device Market, Taiwan, Nephrology and Urology Device Market ($m), Table 16: Medical Device Market, Taiwan, Nephrology and Urology Device Market, Sales Trend for Major Players, Table 17: Medical Device Market, Taiwan, Ophthalmic Device Market ($m), Table 18: Medical Device Market, Taiwan, Ophthalmic Device Market, Sales Trend for Major Players, Table 19: Medical Device Market, Taiwan, In Vitro Diagnostics Device Market ($m),

9 Table of Contents Table 20: Medical Device Market, Taiwan, In Vitro Diagnostics Device Market, Sales Trend for Major Players, Table 21: Medical Device Market, Taiwan, Cardiovascular Device Market ($m), Table 22: Medical Device Market, Taiwan, Cardiovascular Device Market, Sales Trend for Major Players, Table 23: Medical Device Market, Taiwan, Orthopedic Device Market ($m), Table 24: Medical Device Market, Taiwan, Orthopedic Device Market, Sales Trend for Major Players, Table 25: Medical Device Market, Taiwan, Diagnostic Market, Revenue ($bn), Table 26: Medical Device Market, Taiwan, Diagnostic Market, Revenue ($bn), Table 27: Major Products, Baxter International, Global, Revenue, Table 28: Major Products, Fresenius Medical Care, Table 29: Major Products, Medtronic, Table 30: Healthcare System, Taiwan, NHI Premium Formulas, Table 31: Healthcare System, Taiwan, Basic Outpatient Care Co-payments, Table 32: Healthcare System, Taiwan, Basic Outpatient Care Co-payments, Table 33: Healthcare Spending, Taiwan, Out-of-Pocket Expenditure (%), Table 34: Price of Prescription Drugs, Taiwan, Price Trend in Healthcare Services (%), Table 35: Healthcare System, Taiwan, Registration Fee Structure for New Drug Application ($), Table 36: Healthcare System, Taiwan, Regulatory Requirement for Medical Devices, Table 37: Market Access, Taiwan, Schedule of Patent Fees, Table 38: Market Access, Taiwan, Schedule of Trademark Fees, Table 39: Economic Indicators, Taiwan, Gross Domestic Product per Capita ($), Table 40: Economic Indicators, Taiwan, Gross Domestic Product per Capita Forecast ($), Table 41: Economic Indicators, Taiwan, Gross Domestic Product Annual Growth (%),

10 Table of Contents Table 42: Economic Indicators, Taiwan, Gross Domestic Product Annual Growth Forecast (%), Table 43: Economic Indicators, Taiwan, National Income per Capita ($), Table 44: Economic Indicators, Taiwan, Average Consumer Price Index, Table 45: Economic Indicators, Taiwan, Average Consumer Price Index Forecast, Table 46: Economic Indicators, Taiwan, Average Consumer Price Annual Change (%), Table 47: Economic Indicators, Taiwan, Currency Exchange Rate (TWD/$), Table 48: Economic Indicators, Taiwan, Foreign Direct Investment ($bn), Table 49: Economic Indicators, Taiwan, Foreign Exchange Reserves ($bn), Table 50: Economic Indicators, Taiwan, Imports of Goods and Services ($bn), Table 51: Economic Indicators, Taiwan, Exports of Goods and Services ($bn), Table 52: Economic Indicators, Taiwan, Government Structural Balance ($bn), Table 53: Economic Indicators, Taiwan, General Government Gross Debt (% of GDP), Table 54: Economic Indicators, Taiwan, General Government Gross Debt Forecast (% of GDP), Table 55: Economic Indicators, Taiwan, Major Industries, Gross Domestic Product by Industry ($bn), Table 56: Demographics, Taiwan, Population (million), Table 57: Demographics, Taiwan, Population Forecast (million), Table 58: Demographics, Taiwan, Urban-Rural Population (%), Table 59: Demographics, Taiwan, Population Distribution by Age Group (%), Table 60: Demographics, Taiwan, Population Distribution by Age Group Forecast (%), Table 61: Demographics, Taiwan, Births (per 1,000 population), Table 62: Demographics, Taiwan, Mortality (per 1,000 population), Table 63: Demographics, Taiwan, Major Causes of Mortality (per 100,000 population),

11 Table of Contents Table 64: Demographics, Taiwan, Children under Five, Infant Mortality Rate (per 1,000 live births), Table 65: Demographics, Taiwan, Immunization Rate (%), Table 66: Demographics, Taiwan, Gender Ratio (M/F), Table 67: Demographics, Taiwan, Life Expectancy at Birth (years), Table 68: Demographics, Taiwan, Student Net Enrollment by Level of Education (%), Table 69: Demographics, Taiwan, Unemployment Rate (%), Table 70: Demographics, Taiwan, Employment by Sector ( 000), Table 71: Demographics, Taiwan, Personal Health Expenditure by Disease (%), Table 72: Healthcare Infrastructure, Taiwan, Hospitals, Table 73: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, Table 74: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership, Table 75: Healthcare Infrastructure, Taiwan, Private Hospitals, Share by Ownership, Table 76: Healthcare Infrastructure, Taiwan, Hospitals by Standard of Care, Contracted by NHIA, Table 77: Healthcare Infrastructure, Taiwan, Hospitals by Services Rendered, Table 78: Healthcare Infrastructure, Taiwan, Beds by Type of Hospital, Table 79: Healthcare Infrastructure, Taiwan, Beds by Specialty Care, Table 80: Healthcare Infrastructure, Taiwan, Diagnostic Equipment, Table 81: Healthcare Infrastructure, Taiwan, Hospital Beds (per 1,000 population), Table 82: Healthcare Infrastructure, Taiwan, Doctors (per 1,000 population), Table 83: Healthcare Infrastructure, Taiwan, PM10 (µgm/m 3 ), Table 84: Healthcare Infrastructure, Taiwan, CO 2 emissions (million tons), Table 85: Healthcare Infrastructure, Taiwan, Nurses (per 1,000 population), Table 86: Healthcare Infrastructure, Taiwan, Pharmacists (per 1,000 population),

12 Table of Contents Table 87: Healthcare Infrastructure, Taiwan, Dentists (per 1,000 population), Table 88: Healthcare Expenditure, Taiwan, Healthcare Expenditure (% of GDP), Table 89: Table 90: Healthcare Expenditure, Taiwan, Primary Healthcare Expenditure, Current Health Expenditure by Provider (%), Healthcare Expenditure, Taiwan, Primary Healthcare Expenditure, Current Health Expenditure by Mode of Production (%), Table 91: Healthcare Expenditure, Taiwan, Healthcare Expenditure, Public-Private Share (%), Table 92: Healthcare Expenditure, Taiwan, Pharmaceutical R&D Expenditure, Table 93: Healthcare Expenditure, Taiwan, Major Healthcare Trade Fairs, List of Figures Figure 1: Pharmaceutical Market, Taiwan, Revenue ($bn), Figure 2: Pharmaceutical Market, Taiwan, Revenue Forecast ($bn), Figure 3: Pharmaceutical Market, Taiwan, Exports and Imports ($bn), Figure 4: Pharmaceutical Market, Taiwan, Market Segments of Newly Emerging Biotech Industry by Share (%), Figure 5: Medical Device Market, Taiwan, Revenue ($bn), Figure 6: Medical Device Market, Taiwan, Revenue Forecast ($bn), Figure 7: Medical Device Market, Taiwan, Nephrology and Urology Device Market ($m), Figure 8: Medical Device Market, Taiwan, Nephrology and Urology Device Market, Sales Trend for Major Players ($m), Figure 9: Medical Device Market, Taiwan, Ophthalmic Device Market ($m), Figure 10: Medical Device Market, Taiwan, Ophthalmic Device Market, Sales Trend for Major Players ($m), Figure 11: Medical Device Market, Taiwan, In Vitro Diagnostics Device Market ($m),

13 Table of Contents Figure 12: Medical Device Market, Taiwan, In Vitro Diagnostics Device Market, Sales Trend for Major Players ($m), Figure 13: Medical Device Market, Taiwan, Cardiovascular Device Market ($m), Figure 14: Medical Device Market, Taiwan, Cardiovascular Device Market, Sales Trend for Major Players ($m), Figure 15: Medical Device Market, Taiwan, Orthopedic Device Market ($m), Figure 16: Medical Device Market, Taiwan, Orthopedic Device Market, Sales Trend for Major Players ($m), Figure 17: Medical Device Market, Taiwan, Diagnostic Market, Revenue ($m), Figure 18: Medical Device Market, Taiwan, Diagnostic Market, Revenue ($bn), Figure 19: Healthcare Market, Taiwan, Drivers and Barriers, Figure 20: Healthcare System, Taiwan, Financial Flow in Healthcare System, Figure 21: Healthcare System, Taiwan, Evolution of Healthcare System, Figure 22: Healthcare System, Taiwan, Reimbursement Process, Figure 23: Market Access, Taiwan, Process for Coverage and Reimbursement of Medical Devices, Figure 24: Healthcare System, Taiwan, Premium Collection under Second-Generation NHI System, Figure 25: Healthcare Spending, Taiwan, Out-of-Pocket Expenditure (%), Figure 26: Price of Prescription Drugs, Taiwan, Price Trend in Healthcare Services (%), Figure 27: Market Access, Taiwan, Organization Structure of Center for Drug Evaluation, Figure 28: Market Access, Taiwan, Marketing Authorization Procedure for New Drug, Figure 29: Market Access, Taiwan, New Drug Evaluation Process, Figure 30: Market Access, Taiwan, HTA Process for New Drug Listing Application with the NHIA, Figure 31: Market Access, Taiwan, Marketing Authorization Procedure for Medical Devices, Figure 32: Market Access, Taiwan, Clinical Trial Regulation Process for an Investigational New Drug,

14 Table of Contents Figure 33: Economic Indicators, Taiwan, Gross Domestic Product per Capita ($), Figure 34: Economic Indicators, Taiwan, Gross Domestic Product per Capita Forecast ($), Figure 35: Economic Indicators, Taiwan, GDP Annual Growth (%), Figure 36: Economic Indicators, Taiwan, Gross Domestic Product Annual Growth Forecast (%), Figure 37: Economic Indicators, Taiwan, National Income per Capita ($), Figure 38: Economic Indicators, Taiwan, Average Consumer Price Index, Figure 39: Economic Indicators, Taiwan, Average Consumer Price Index Forecast, Figure 40: Economic Indicators, Taiwan, Average Consumer Price Annual Change (%), Figure 41: Economic Indicators, Taiwan, Currency Exchange Rate (TWD/$), Figure 42: Economic Indicators, Taiwan, Foreign Direct Investment ($bn), Figure 43: Economic Indicators, Taiwan, Foreign Exchange Reserves ($bn), Figure 44: Economic Indicators, Taiwan, Imports of Goods and Services ($bn), Figure 45: Economic Indicators, Taiwan, Exports of Goods and Services ($bn), Figure 46: Economic Indicators, Taiwan, Government Structural Balance ($bn), Figure 47: Economic Indicators, Taiwan, General Government Gross Debt (% of GDP), Figure 48: Economic Indicators, Taiwan, General Government Gross Debt Forecast (% of GDP), Figure 49: Economic Indicators, Taiwan, Major Industries, Gross Domestic Product by Industry ($bn), Figure 50: Demographics, Taiwan, Population (million), Figure 51: Demographics, Taiwan, Population Forecast (million), Figure 52: Demographics, Taiwan, Urban-Rural Population (%), Figure 53: Demographics, Taiwan, Population Distribution by Age Group (%), Figure 54: Demographics, Taiwan, Population Distribution by Age Group Forecast (%),

15 Table of Contents Figure 55: Demographics, Taiwan, Births (per 1,000 population), Figure 56: Demographics, Taiwan, Mortality (per 1,000 population), Figure 57: Demographics, Taiwan, Major Causes of Mortality (per 100,000 population), Figure 58: Demographics, Taiwan, Children under Five, Infant Mortality Rate (per 1,000 live births), Figure 59: Demographics, Taiwan, Immunization Rate (%), Figure 60: Demographics, Taiwan, Gender Ratio (M/F), Figure 61: Demographics, Taiwan, Life Expectancy at Birth (years), Figure 62: Demographics, Taiwan, Student Net Enrollment by Level of Education (%), Figure 63: Demographics, Taiwan, Unemployment Rate (%), Figure 64: Demographics, Taiwan, Employment by Sector ( 000), Figure 65: Demographics, Taiwan, Personal Health Expenditure by Disease (%), Figure 66: Healthcare Infrastructure, Taiwan, Hospitals, Figure 67: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, Figure 68: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership (%), Figure 69: Healthcare Infrastructure, Taiwan, Private Hospitals, Share by Ownership (%), Figure 70: Healthcare Infrastructure, Taiwan, Hospitals by Standard of Care, Contracted by NHIA, Figure 71: Healthcare Infrastructure, Taiwan, Hospitals by Services Rendered (%), Figure 72: Healthcare Infrastructure, Taiwan, Beds by Type of Hospital, Figure 73: Healthcare Infrastructure, Taiwan, Beds by Specialty Care, Figure 74: Healthcare Infrastructure, Taiwan, Diagnostic Equipment, Figure 75: Healthcare Infrastructure, Taiwan, Hospital Beds (per 1,000 population), Figure 76: Healthcare Infrastructure, Taiwan, Doctors (per 1,000 population), Figure 77: Healthcare Infrastructure, Taiwan, PM10 (µgm/m 3 ),

16 Table of Contents Figure 78: Healthcare Infrastructure, Taiwan, CO 2 emissions (million tons), Figure 79: Healthcare Infrastructure, Taiwan, Nurses (per 1,000 population), Figure 80: Healthcare Infrastructure, Taiwan, Pharmacists (per 1,000 population), Figure 81: Healthcare Infrastructure, Taiwan, Dentists (per 1,000 population), Figure 82: Healthcare Expenditure, Taiwan, Healthcare Expenditure (% of GDP), Figure 83: Healthcare Expenditure, Taiwan, Primary Healthcare Expenditure, Current Health Expenditure by Provider (%), Figure 84: Healthcare Expenditure, Taiwan, Primary Healthcare Expenditure, Current Health Expenditure by Mode of Production (%), Figure 85: Healthcare Expenditure, Taiwan, Healthcare Expenditure, Public-Private Share (%), Figure 86: Healthcare Expenditure, Taiwan, Pharmaceutical R&D Expenditure ($m), Figure 87: Healthcare Market, Taiwan, Opportunities and Challenges,

17 Introduction 2 Introduction 2.1 GlobalData Report Guidance The chapter begins with an executive summary, which gives an overview of the Taiwan s healthcare market and the key driving factors. It also gives a snapshot of the demographic, regulatory, and reimbursement landscape, and the healthcare infrastructure. Chapter three provides an overview of Taiwan s pharmaceutical and medical device markets, covering size; generic, Over-the-Counter (OTC) and biologic/biosimilar product shares; and the key drivers and barriers. It also includes profiles of the major players, as well as SWOT assessments. Chapter four covers the reimbursement and payer landscape, and includes details of the reimbursement process, insurance providers, pricing policies and drug price trends in Taiwan. It also looks at the regulatory landscape, and gives an overview of the regulatory agencies and approval processes for new drugs and medical devices. Also covered is the licensing process for the manufacture, export and import of pharmaceuticals; regulations for pharmaceutical advertising, labeling, packaging and clinical trials; and an overview of intellectual property rights. Chapter five provides detailed analysis of the political and economic environment in Taiwan, and analyses economic indicators, demographics, and healthcare infrastructure and expenditure. Chapter six provides an overview of the opportunities for and challenges to growth in Taiwan s healthcare market. 19

18 Country Analysis Public and Private Hospitals From 2008 to 2013, the number of private institutions decreased at a negative CAGR of XX%, owing to consolidation, yet they still dominated the market. The number of public hospitals increased slightly from XX hospitals in 2008 to XX hospitals in 2013 (MoHW, 2014b). Even though the number of private hospitals decreased, the number of corporate owned hospitals increased from XX to XX. This was due to the tax breaks given to hospitals, which made them ideal for corporate investment. Figure 67: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, Hospitals Public Private Source: MoHW, 2014b Table 73: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, Government Private Source: MoHW, 2014b

19 Country Analysis Figure 68: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership (%), 2013 Hospitals affiliated to organization (institution) Public chinese medicine hospitals Hospitals of VACRS MoHW hospital and municipality hospital Civilian clinics of military hospitals Hospitals affiliated to public medical schools County and city hospitals Source: MoHW, 2014b VACRS: Vocational Assistance Commission for Retired Servicemen Table 74: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership, 2013 Type of hospital Number of facilities Share (%) DoH and municipality hospitals Vocational Assistance Commission for Retired Servicemen hospitals Civilian clinics of military hospitals Hospitals affiliated to public medical schools County and city hospitals Hospitals affiliated to an organization Public Chinese medicine hospitals Source: MoHW, 2014b 194

20 Appendix 7 Appendix 7.1 Abbreviations µgm/m 3 : 5in1: AC: ANDA: API: ASEAN: BACE: BNHI: BOPA: CAGR: CCPC: CDE: CDI: cgmp: CKD: CMO: CNS: CE: COPD: CPI: CRAMS: CRL: micrograms per cubic meter DTaP-Hib-IPV Advisory Committee Abbreviated New Drug Application Active Pharmaceutical Ingredients Association of Southeast Asian Nations Beta Secretase Bureau of NHI Bureau of Pharmaceutical Affairs Compound Annual Growth Rate China Chemical & Pharmaceutical Co. Center for Drug Evaluation Clostridium Difficile Infection Current Good Manufacturing Practice Chronic Kidney Disease Contract Manufacturing Outsourcing Central Nervous System Conformité Européenne Chronic Obstructive Pulmonary Disease Consumer Price Index Contract Research and Manufacturing Services Complete Response Letter 222

21 Appendix CRO: CT: DBC: DET: DoH: DP: DPP: ECFA: EMA: EMAP: EPA: ESRD: FDA: FDI: Forex: FEPZ GCP: GCRC: GDP: GMP: HBP: HPA HepB: HIV: Contract Research Outsourcing Computed Tomography Drug Benefit Committee Drug Expenditure Target Department of Health Doctors-to-Population Democratic Progressive Party Economic Cooperation Framework Agreement European Medicines Agency EMA Emerging Markets Asia-Pacific Environmental Protection Administration End-Stage Renal Disease Food and Drug Administration Foreign Direct Investments Foreign exchange Free Economic Pilot Zones Good Clinical Practice General Clinical Research Center Gross Domestic Product Good Manufacturing Practice Hospital-Beds-to-Population Health Promotion Agency Hepatitis B vaccine Human Immunodeficiency Virus 223

22 Appendix HTA: ICD: IDEA: IDSA: IMF: impro: IPR : IRB: IVD: JE: JIRB: KMT: LIS: MMR: MoHW: MRI: NCE: NDA: NHE: NHI: NHIA: NRPB: OECD: OTC: Health Technology Assessment Implantable Cardioverter-Defibrillators International Design Excellence Awards Industrial Designers Society of America International Monetary Fund Integrated Medicinal Products Review Office Intellectual Property Right Institutional Review Boards In Vitro Diagnostics Japan Encephalitis vaccine Joint Institutional Review Boards Nationalist Party (Kuomintang) Laboratory Information System Measles, Mumps and Rubella combination vaccine Ministry of Health and Welfare Magnetic Resonance Imaging New Chemical Entity New Drug Application National Health Expenditure National Health Insurance National Health Insurance Administration National Research Program for Biopharmaceuticals Organization for Economic Co-operation and Development Over-the-Counter 224

23 Appendix PACS: PM10: PET) PMF: PUD: QSD: R&D: ROC: CDC TCM: TEPA: TFDA: TGPA: TIPO: UNFCCC: UNICEF: VACRS: VAR: WTO: YSP: Picture Archiving Communication Systems Particulate Matter with an aerodynamic diameter of less than 10 micrometers Positron Emission Tomography Plant Master Files Peptic Ulcer Disease Quality Systems Documentation Research and Development Republic of China Taiwan Center for Disease Control Traditional Chinese Medicine Taiwan Environmental Protection Agency Taiwan Food and Drug Administration Taiwan Generic Pharmaceutical Association Taiwan Intellectual Property Office United Nations Framework Convention on Climate Change United Nations Children s Fund Vocational Assistance Commission for Retired Servicemen Varicella vaccine World Trade Organization Yung Shin Pharmaceutical 225

24 Appendix 7.2 Bibliography 10times (2015). Medical and pharmaceutical trade shows in Taiwan. 10times. Available from: [Accessed on April 22, 2015] Baxter (2014). Baxter 10k filings. Baxter. Available from: baxter_form10-k.pdf CBC (2015). Monthly Releases: Foreign Exchange Reserves. Central Bank of the Republic of China (Taiwan). Available from: [Accessed on April 21, 2015] CCPC (2014). China Chemical & Pharmaceutical company info. China Chemical & Pharmaceutical. Available from: [Accessed on May 13, 2015] CDC (2014). Annual report Center for Disease Control. Available from: CDE (2014a). Organization. Center for Drug Evaluation. Available from: [Accessed on May 6, 2015] CDE (2014b). Drug Review and Registration Guideline. Center for Drug Evaluation. Available from: [Accessed on May 6, 2015] CDE (2014c). Fee schedule for the application of examination and registration of pharmaceuticals and medical equipment. Center for Drug Evaluation. Available from: [Accessed on May 6, 2015] CDE (2014d). Guideline for Registration of Medical Devices. Center for Drug Evaluation. Available from: CDE (2014e). Guideline for Good Clinical Practice. Center for Drug Evaluation. Available from: [Accessed on May 6, 2015]. 226

25 Appendix 7.3 Research Methodology GlobalData s dedicated research and analysis teams consist of experienced professionals with advanced statistical expertise and marketing, market research and consulting backgrounds in the pharmaceutical industry. GlobalData adheres to the codes of practice of the Market Research Society ( and Strategic and Competitive Intelligence Professionals ( All GlobalData databases are continuously updated and revised. The following research methodology is followed for all databases and reports Coverage The objective of updating GlobalData s coverage is to ensure that it represents the most up-to-date vision of the industry possible. Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources. Company coverage is based on three key factors: revenue; products; and media attention, innovation and market potential. The estimated revenue of all major companies, including private and governmental, are gathered and used to prioritize coverage. Companies that are making the news or are of particular interest due to their innovative approach are prioritized. GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated on a daily basis. The coverage is further streamlined and strengthened with additional input from GlobalData s expert panel (see below). 239

26 Appendix Secondary Research The research process begins with extensive secondary research using internal and external sources to gather qualitative and quantitative information relating to each market. The secondary research sources that are typically referred to include, but are not limited to: Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings Industry trade journals, scientific journals and other technical literature Internal proprietary databases Relevant patent and regulatory databases National government documents, statistical databases and market reports Procedure registries News articles, press releases and web-casts specific to the companies operating in the market The CountryFocus reports are largely based on secondary research and use reliable and authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, BEA, MHLW and NHS, among others Forecasts The CountryFocus reports use the data available from the secondary sources to forecast and validate the future trends for a country s healthcare market, as well as parameters related to the economy and healthcare infrastructure and expenditure Expert Panel GlobalData uses a panel of experts to cross-verify its databases and forecasts. GlobalData s expert panel comprises marketing managers, product specialists, international sales managers from pharmaceutical companies, academics from research universities, consultants from venture capital funds, and distributors/suppliers of pharmaceuticals and supplies. Historic data and forecasts are relayed to GlobalData s expert panel and adjusted in accordance with their feedback. 240

27 Appendix 7.4 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. 241