Bioanalysis Zone

Update on Chinese Regulated Bioanalysis


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1 Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences
2 GlaxoSmithKline R&D Shanghai
3 Institute of Clinical Pharmacology, Peking University
4 Beijing eStart Medical Technology
5 United-Power PharmaTech (*Corresponding author,

Fast growing pharmaceutical R&D in China

China has become the second largest economy this decade with an average GDP growth of > 8% in the past 30 years. Meanwhile the Chinese pharmaceutical market has grown to the second largest in the world with a growth rate of 20% per year in the past 10 years. It has been widely appreciated that China’s pharmaceutical market is one of the major growth drivers in the global market. In light of the large patient population with a high demand of unmet medical needs, investment in Chinese drug R&D has seen one of the fastest growth rates in the world with double digit increases in the past 5 years. The evolving local pharma R&D ecosystem, particularly the governmental support and rapid growing talent pool, will enable China to build a strong presence in the global R&D landscape in upcoming years.

The local pharmaceutical industry is also growing with an unprecedented speed. Chinese Pharma companies have been focusing on generic drugs and Traditional Chinese Medicine (TCM). While encouraging the industry to move toward ’internationalization’ by obtaining approval from the US FDA/EMA on their generic products, recently, the Chinese government has been investing heavily in new drug development programs, especially in attractive areas such as biosimilars and novel biologics. Some large local Pharma companies supported by government funds have established their own R&D centers with growing pipelines at Investigational New Drug (IND) or even clinical Phase III. The emergence from businesses with low R&D investment to more innovative drug R&D has also been encouraged. It is inevitable that the rapid growth in local registration trials and global clinical trials offers a great opportunity and challenge to the local bioanalytical community.

Chinese bioanalysis regulation landscape

To cope with the fast growth of drug development, the China Food and Drug Administration (CFDA) has been actively involved in promoting practices of cGMP, GCP and GLP (mainly in preclinical animal testing). There is a great need for regulated bioanalysis to be embedded as well.

Currently there are several guidelines related to biological sample analysis in China, each with its own scope. So far no independent bioanalytical guidance has been issued by the CFDA for novel drugs. For nonclinical studies, sample analysis should follow “The guideline on the non-clinical pharmacokinetic study (issued in 2014)” [1]. In clinical research studies, the relevant provisions of “The guideline on the clinical pharmacokinetic study of chemical drugs (issued in 2005)” [2] and “The guideline on the bioavailability and bioequivalence study of chemical drugs (issued in 2005)” [3] should be followed.

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