Hong Kong An Asian Hub for Clinical Trials

Hong Kong is an outstanding modern international metropolis in Asia. For decades it has been well-known for its unrivalled location, state-of-the-art infrastructure, high-calibre workforce, transparent legal system and free flow of information, as well as its international lifestyle. Besides being an Asian business and logistics centre, Hong Kong has also emerged as an Asian hub for clinical research. Hong Kong's history of clinical research can be traced back to the foundation of the Hong Kong College of Medicine in 1887. Adoption of the ICH GCP guidelines in 1996 facilitated international collaboration, which stimulated an upsurge of clinical research activities in Hong Kong. The number of certificates for clinical trial issued by the Hong Kong Department of Health increased sharply from the level of around 20 per year before the mid-1990s to 139 in 2002. Hong Kong's outstanding conditions have been attracting a continuous inflow of industrial sponsorship of phase I to IV clinical trials. Most of the major research-based healthcare and medical product companies, including the top 20 global pharmaceutical companies, have already run their clinical trials in Hong Kong.

Hong Kong's Cutting Edges

Dense Population A dense population of 6.8 million Patients are easily accessible through the healthcare system under the Hospital Authority

Excellent Infrastructure Excellent public healthcare system consisting of 42 hospitals, 47 specialist clinics and 13 general outpatient clinics managed by the Hospital Authority, which contributes to a low infant mortality rate of 3/1000 and an average life expectancy of 80 years Centralized electronic patient records accessible on an intranet system linking all hospitals and clinics under the Hospital Authority Accredited central laboratory facilities capable of supporting multinational clinical trials Prime logistical hub which is less than five hours' flight from most Asian countries and links to some 130 destinations worldwide by over 3,600 flights per week

Rich Research Experience and Highly Qualified Investigators Decades of experience in clinical research as illustrated by the large quantity of quality scientific publications in clinical research Vast experience in conducting phase I to IV clinical trials in a wide range of therapeutic areas Extensive collaboration with multinational and local trial sponsors Full compliance with the ICH GCP guidelines and other international standards Satisfactory regulatory inspections by overseas regulatory agencies, including the US Food and Drug Administration (FDA) and Japan Ministry of Health, Labour and Welfare (MHLW) Key opinion leaders in various research areas

High Quality Ethics Committees Six cluster ethics committees overseeing clinical research in all hospitals and clinics under the Hospital Authority Harmonized guidelines and application procedure among the six cluster ethics committees Fully compliant with the ICH GCP guidelines in terms of composition and operation Review of clinical research applications by regular meetings Comprehensive training organized for all ethics committee members

Simple Regulatory Requirements Parallel regulatory and ethics committee applications permitted Fast regulatory review process which normally takes only eight weeks

Reasonable Cost Significantly lower costs relative to North America and Europe while achieving the same quality