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Taiwan


Fast Facts

  • Capital: Taipei
  • Economy: Dynamic capitalist, export-driven economy with gradually decreasing state involvement in investment and foreign trade, nominal GDP: US$529 billion, 2014
  • Health Expenditure: 6.63% of GDP, 2013
  • Population: 23.4 million, 2014
  • Average Life Span: 76 / 82 (m/f), 2014
  • Languages: Taiwanese, Mandarin (Traditional Chinese), Hakka and basic English
  • Adult Literacy Rate: 98.29% 2014

Health Trends

  • Healthcare in Taiwan is administrated by the Department of Health of the Executive Yuan. 
  • National Health Insurance Program launched March 1, 1995. It is universal, mandatory, and comprehensive. The program covers 63.2 % of population national wide (2010).
  • Bureau of National Health Insurance (BNHI) collects premiums from the insured and reimburses medical payments to health care providers. 
  • Leading causes of death: Cancer, Heart diseases, Cerebrovascular diseases, Pneumonia, Diabetes Mellitus, Accidents, Chronic Respiratory Disease, Chronic Liver Disease and Cirrhosis, Suicide and Nephritis, Nephritic Syndrome and Nephrosis. 
  • The top 5 incidence of cancer: Colorectal Cancer, Liver Cancer, Lung Cancer, Breast Cancer, and Oral Cancer

Clinical Trial Landscape

  • GCP announced in 1996, fully implemented 1997.
  • GCP inspection implemented in 1997 for all studies for local registration purpose and triggered by the study report submitted to HA.
  • Parallel submission to IRB and HA after year 2001.
  • Clinical trials set-up time: approx 9-12 weeks.
  • Second highest country in Asia Pacific to be involved in FDA studies.
  • Investigators must be GCP-trained with certificated course score presented to participate and conduct clinical trials
  • Most institutions have clinical trial centres which can assist in the set-up, conduct and coordination of clinical trials.
  • Strong Government support to conduct early global trials.

Regulatory Information

  • Clinical trials set-up time: approx 148 days. 
  • Second highest country in Asia Pacific to be involved in FDA studies. 
  • 10 December 2010, China and Taiwan entered agreement (pact of 15th commercial agreement) as a platform for the two sides to develop the biotechnology industry and facilitate the development of new drugs and clinical trials (I would not suggest to put this as still under the discussions)
  • Taiwan FDA - streamline product regulation, consumer protection, crisis management of product safety, and international affairs. The average IND review time, including all sponsor time, is 34.5 calendar days and from CTA submission to issue approval letter is 40.7 calendar days. 
  • CDE provides scientific advice according to the specific need of each individual sponsor. 

Sites

  • Adheres to ICH GCP guidelines closely 
  • 19 medical centers around the island: Over 10,000 OPD patients per day in top 3 medical centers and over 2,000 beds in 7 medical centers. 
  • Most IRB of medical centers obtain FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) accreditation 
  • Clinical Research Center in most of the medical centers which can assist in the set-up, conduct and coordination of clinical trials: Partially funded by the government and specialized in Neurology/Stroke, Oncology, or Herbal/Traditional medicine. 130 teaching hospitals are qualified to carry out clinical trials 
  • Physicians were trained in English thus majority of source documents and medical chart are made in English.  
  • Strong Government support to conduct early global trials.
     

ICON in Taiwan

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  • Presence in Taiwan office since 2006 
  • 67 employees, 2015
  • Staffs have broad therapeutic experience in particular oncology 
  • Experience with Phase I - IV studies including First-In-Man. Excellent relationships with key opinion leaders in various therapeutic areas and the evolving CDE and regulatory authorities.
  • Strategic partnership with key medical centers to expedite study set-up and enhance study delivery  
     

Services Offered

  • Major services: Clinical Operations and Regulatory Consultancy
  • Project Management
  • Clinical Monitoring
  • Medical & Safety Services
  • Regulatory support
  • Training
  • DOCS resourcing solutions:
    • Functional Resourcing 
    • Flexible Resourcing
    • Permanent Recruitment 

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