Complex rules and regulations can make conducting trials in mainland China a challenge. This is despite that fact its pharmaceutical market is the second-largest in the world with an annual growth rate of 9.1%.

Due to its geography and relationship with China, Hong Kong attracts the world as a gateway to clinical research in China. Providing excellent infrastructure and well-established research institutes has garnered Hong Kong official recognition as a location to conduct clinical trials for drug registration in China.

For these reasons, Hong Kong can serve as a gateway opportunity to the mainland.

University of Hong Kong Clinical Trials Centre (HKU-CTC)

The HKU-CTC was established in 1998 as an academic clinical research institute. The HKU-CTC works with clinical investigators, other research institutes, and the healthcare industry to promote, attract, and facilitate a wide variety of clinical trials.

Since its beginning, the HKU-CTC has developed into a leading full-service organization. It has implemented:

• Over 880 sponsored clinical studies
• Over 100 investigator-initiated clinical research exercises in collaboration with more than 200 sponsors abroad and
• Over 100 clinical investigators at the University of Hong Kong (HKU)

This is at the HKU alone.

Information obtained from www.clinicaltrials.gov indicates that some 100 studies commenced in Hong Kong each year between 2014 and 2016.

Hong Kong Science & Technology Parks Corporation (HKSTP)

Combining Science Park, InnoCentre, and Industrial Estates the statutory body HKSTP continues to build a strong innovation and technology ecosystem.

Since its establishment in May 2001, HKSTP has been a regional hub for growth and innovation in several clusters, including the biomedical technology.

Two medical schools (with clinical trial centers of their own) and over 80 biomedical technology enterprises at HKSTP also serve as a biotech hub for clinical trials in Hong Kong and across Asia.

Government commitment of monetary resources to phase 1 and 2 capabilities

In 2011, Hong Kong's government allocated HK$1 billion to a new health and medical research fund to promote phase 1 trials. Prior to this, Hong Kong's capability in clinical trials had been limited. More than half of Hong Kong's clinical trials were focused on phase 3 and another quarter was on phase 4.

Understanding that phase 3 trials can be conducted more feasibly in mainland China due to its sizeable population, Hong Kong is now committed to building solid phase 1 and 2 capabilities.

Hong Kong's intention is to move trials to the mainland for phase 3 as an efficient resource allocation strategy.

Official recognition from the China State Food and Drug Administration (CFDA)

Hong Kong is officially recognized by the CFDA as a location to conduct clinical trials for drug registration in China (for certain therapeutic areas).

Trial data from Hong Kong can be used to file new drug applications, making Hong Kong a perfect gateway to the mainland.