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China


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Fast Facts

  • Capital: Beijing
  • Economy: GDP/Economy: 2nd largest economy in the world, nominal GDP US$10.35 trillion, 2014
  • Health Expenditure: 5.6% of GDP, 2013
  • Population: 1.37 billion, as of Oct 2015
  • Average Life Span: 74/77 (m/f), 2013
  • Languages: China has 56 ethnic groups, the Hui and Manchu use the same languages as Han people, other groups have own spoken and written languages
  • Adult Literacy Rate: 95.1% 2013

Health trends

  • The Ministry of Health of the State Council oversees the health services system, which includes a substantial rural collective sector but little private sector. Nearly all the major medical facilities are run by the government.
  • 40,000 social welfare institutions of various types providing 3.123 million beds, accommodating 2,365 thousand inmates and 31,000 were rural elder-caring organizations providing 2.139 million beds, accommodating 1,704 thousand inmates in 2010.
  •  The 12th Five-Year Plan, issued in March 2011, encourages innovation throughout the biomedical industry, broadly defined as covering pharmaceuticals, vaccines, medical products and traditional Chinese medicine. 
  • Smoking related illnesses kill 1.2 million in the People's Republic of China in 2011. 
  • Tuberculosis is a major public health problem in China, which has the world's second largest tuberculosis epidemic
  • Every year, 300,000 people die from hepatitis B virus related diseases in China

Clinical Trial Landscape

  • First draft China GCP published in 1999. 
  • Westernise disease pattern and malignacy as the leading cause of mortality.
  • NCE approval timeline shortened from approx 14 months.
  • New biologics approval timeline - approx 26 months after regulatory submission.
  • Clinical trial sites must be accredited by China State Food & Drug Administration (SFDA)
  • Based on timeline of different category of investigational product (IP), overall start-up timeline (RA+SSU with HGRA application/approval) in China:
    • approx. 19 months (from CTA application to 1st SIV) for chemicals;
    • 31 months for biologics (from CTA application to 1st SIV).
  • CFDA targets to get the balance between submission and completion of the review for drug registration by the end of 2016, and all reviews for drug registration are completed within statutory timeline in 2018.  
  • Increasing trend of earlier involvement of China participation in global development to shorten launch of product to the market by 2-3 years.

Regulatory Information

  • CFDA for an administrative review and issuance of the Clinical Trial Authorization (CTA). The statutory timeline for a CTA is 155 working days, but the actual timeline on average can take from 12 to 15 months 
  • The statutory timeline for an Import Drug License is 215 days, but the actual timeline on average can take up to 26 months
  • China Food & Drug Administration (CFDA) - responsible for registration & Supervision of Drugs, Medical Devices and Health Food.
  • Centre for Drug Evaluation (CDE)- responsible for evaluation of drug covering both chemicals and biologics 
  • Global Trial Start-Up Timeline = Regulatory Approval time plus IRB and contract negotiation and HGRA (human genetic resource administration) approval time. 
  • Dossier preparation 8 weeks on average. 
  • Administration examination approval by CFDA - approx 1 month. 
  • Overall timeline for approval after submission to CFDA - 14 months (chemicals) to 26 months (biologics). 
  • HGRA application starts only after CTA approval and EC approval
  • HGRA Approval by CHGRAO-approx. 3.5-4 month 
  • Start up Timeline for Global Trial in China – approx. 15 months.

Sites

  • Increasing participation in global clinical trials enhance sites capability to align with global practices.
  • Need to be cognizant of language and culture
  • CFDA-certified drug clinical trial institutions are qualified to conduct clinical trials in specifically approved therapeutic areas.
  • Clinical trial sites must be accredited by China State Food & Drug Administration (CFDA)