- Foreword
- Advisory Board
- Introduction - CCT
- Training and Education
Provided by CCT
> SFDA Inspection and Accreditation
- Ethics Committee
- Central Laboratories
- Clinical Trials Capabilities
 Cardiology
 Clinical Oncology
 Digestive and
 Liver Diseases
 Endocrinology
   Ophthalmology
   Phase I Studies Unit
   Paediatrics
   Anaesthesia and
 Intensive Care
   Community and
 Family Medicine
   Neurology
   Orthopedic and
 Traumatology
   Psychiatry
   Rheumatology
   Surgery
 
 

SFDA Inspection and Accreditation

SFDA Accreditation

The CUHK, together with the Prince of Wales Hospital (PWH), obtained approval from the State Food and Drug Administration (SFDA) of China on August 1, 2006, to carry out clinical trials for Mainland China registration purposes in the following 10 disciplines:

  • Digestive Diseases消化
  • Oncology腫瘤
  • Endocrinology內分泌
  • Ophthalmology眼科
  • Cardiology心血管
  • Paediatric – haematology小兒血液
  • Paediatric – respiratory小兒呼吸
  • Paediatric – immunology小兒免疫
  • Paediatric – infectious diseases小兒傳染
  • Bioequivalence trials 生物等效性試驗 


CUHK Symposium on Clinical Drug Trials Development for SFDA

To celebrate gaining SFDA accreditation, and to further stimulate university-industry collaboration, CCT organized a symposium on November 1, 2006, titled, “CUHK Clinical Drug Trials Development for China’s SFDA.”

Around 430 people from academic institutions and pharmaceuticals & biotechnology companies attended the event, held at the Hong Kong Convention and Exhibition Centre. Following the symposium, CCT also held a press conference to inform the media about clinical drug trials and SFDA.

Dr. Ling Su (Medical Director of Roche China and HK) and Dr. Janet Lu (Regulatory Affairs Director, MSD China) shared their experiences with the audience on clinical trial application and drug registration in Mainland China during their respective talks titled “Industry Experiences of China’s SFDA Drug Registration Process” and “Regulatory Requirements for Conducting a Clinical Trial in China.”.

The Hong Kong market is relatively small, but nonetheless plays a strategic role in health care development in greater Asia, especially in Mainland China, due to its unique characteristics. These include:

1) Hong Kong, as the leading gateway to China, recently expanded liberalization of various service industries under the Closer Economic Partnership Arrangement (CEPA), in which medical and dental services are listed as important economic sectors.
2) Hong Kong has a simple and low tax system which is attractive to investors and stimulates economic development both in Hong Kong and in Mainland China.
3) Medical institutions can easily collaborate with their counterparts around the world due to all hospital documentation being in English. Moreover, research and clinical personnel in Hong Kong are fluent in both English and Chinese, making global studies easy.
4) Hong Kong is continually striving to raise the standard of its already high quality products and services, which will also contribute to quality control for clinical trials management.