1. Infrastructure:
Hong Kong has excellent infrastructure in terms of transportation, work force and legal framework.
2. English skills and trained staff:
Hong Kong has two official languages- English and Chinese. The English language is used in higher education and in many important sectors of society. Hospital records are all in English. Hong Kong has a highly trained population, with 50% of the working population employed by international companies.
3. Healthcare:
Hong Kong has an outstanding healthcare system, as indicated by one of the lowest infant mortality rates (2-3/1000) and the longest life expectancy (80 for males, 86 for females) in the world. Hong Kong has a population of close to seven million. The 41 public hospitals provide 90% of the medical care in Hong Kong. Public hospital records are computerized and stored in a central computer.
4. Ethics committees:
The 41 public hospitals in Hong Kong are organized into seven clusters. The cluster ethics committees operate according to international standards- including the Declaration of Helsinki and the ICH GCP- and also according to their unified operational guidelines. The ethics committee affiliated with HKU, which is registered with the US Office for Human Research Protections (OHRP), handles over 300 protocols annually. Meetings are scheduled every two weeks.
5. Regulatory framework:
The regulatory framework for testing new drugs in Hong Kong is quite simple. The entire approval process takes two to three months for normal trial. The first requirement is ethics committee approval, which is followed by a regulatory approval for trial conduct and an import license for the test drug. These regulations apply only to drug trials and not to device or cell therapy trials, which are non-governemnt regulated and require only ethics committee approval.
6. China SFDA:
Hong Kong is officially recognized by China State Food and Drug Administration (SFDA) for conducting clinical trials for drug registration purpose in mainland China in certain therapeutic areas. The drug trials in Hong Kong may be used in filing new drug applications in China, within accredited therapeutic areas in recognized medical institutions. For instance, The University of Hong Kong/ Queen Mary Hospital has obtained accreditation for seven therapeutic areas: Endocrinology and Metabolism, Anesthesiology, Hematology and Bone Marrow Transplantation, Cardiology, Obstetrics and Gynecology, Respiratory Medicine and Liver Surgery/ Transplant. Clinical trials in oncology and infectious diseases and on vaccines within each of seven areas are also accredited.
7. Leading trial city:
Hong Kong is among the leading clinical trial cities worldwide. Hong Kong is the third most active industry sponsored clinical trial city in Asia after Seoul and Taipei.
8. Clinical Research Excellence:
Hong Kong has two medicals with many years of high quality clinical research output and has for this reason taken scientific leadership in Asia.
9. Trial Experience:
Hong Kong has a long and impressive track record of conducting global clinical trials. For instance, since the introduction of the ICH GCP guideline in 1996 Hong Kong has participated in over 1000 global clinical trials, all requiring ICH GCP compliance.
10. Leading Trial Centre:
The University of Hong Kong has a leading Clinical Trials Centre in the region with 205 ongoing global clinical trials in early 2008. CTC has also established a trial network- ClinCluster- which makes standardized budgets, contracts and ethical committee applications possible under 41 public hospitals.
