- Very large, homogenous population
- Strong focus of NMPA (previously CFDA) on shortening regulatory timelines
- Largest clinical trial hub in Asia, with over 17,000 active investigators
At more than 1.4 billion people, China is the world’s most populated country, with an increasing shift to living in urban areas.
On the back of major regulatory changes, an increasing number of biotechnology companies are looking at China to run their clinical trials. Biotechnology companies are particularly attracted to the large and accessible treatment-naïve populations and are keen to take advantage of the lower risk of competing trials compared with North America or Europe.
Novotech has established strong clinical teams in China and Hong Kong with deep local knowledge to deliver quality CRO services to biotechnology companies. Novotech has partnered with key specialist hospital and research facilities including the Integrated Oncology Centre as part of its Partner Program, giving Novotech clients direct access to the most active and reputable KOLs, PIs and sites to facilitate study start-up and patient recruitment.
The Chinese National Medical Products Administration (NMPA) encourages fast-track reviews for breakthrough technologies and clinical priority areas, in particular in oncology, orphan and rare diseases. The NMPA issued a series of regulatory reforms focused on improving the drug review process, shortening the Investigational New Drug (IND) and New Drug Application (NDA) review timeline and encouraging new drug innovation.
Hong Kong offers a fast approval timeframe and has established the Clinical Research Ethics Committee of the Hong Kong Doctors’ Union which is empowered to issue IRB approval for research conducted in private practice. Once IRB approval is obtained, principal investigators can apply for a clinical trials certificate from the Department of Health.
Novotech Shanghai Limited
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