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| Biomedical development process large animals (e.g., dogs, pigs and monkeys). While laboratory
standards differ according to experiments, they have to be
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In the biomedical industry, the R&D process for drugs and conducted in laboratories conforming to Good Laboratory
vaccines is the most complex, and conceptually touches on Practice (GLP) guidelines set forth by the competent drug
processes in other areas like genetic testing and therapies and regulator. 27
advanced medical devices. We therefore give a simple overview of
the conventional R&D process for drugs and vaccines in Figure 9, Following the preclinical stage is the clinical trial stage, where
which broadly divides itself into drug discovery, preclinical tests are conducted in the human body. Drug developers are
research, clinical trials and production and product registration. required to submit an Investigational New Drug Process (IND)
application to the competent authorities (see Figure 10). The
The drug discovery stage begins with target discovery, where the clinical stage is divided into four phases, with study participants,
pathogen or genetic mutation of the relevant illness and the signal purpose and length of study varying at each stage. Generally
transduction pathway are identified. The next step is called drug speaking, as the study progresses in phases, the length of study
screening, which is the search for biomolecules or chemicals that and number of participants increase, while technical complexity
can act on the target to treat the disease, and the identification decreases. Therefore, Phase I trials need to be conducted in a
and optimisation of the candidate compounds.
region with established clinical strengths and a shorter length of
Preclinical research, meanwhile, entails pharmacological study, study, while later phases are mainly conducted simultaneously
cellular experiments and animal study. Pharmacological study is around the world with a multicentre approach. Clinical trial
concerned with pharmacodynamics, pharmacokinetics and procedures need to conform to Good Clinical Practice (GCP)
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toxicology study, and can be conducted in vitro (in test tubes or guidelines. The above processes from drug discovery to clinical
cell culture) or in vivo (in the body of animals). Animal tests can be trials may be conducted by pharmaceutical companies
conducted in laboratories designed for small animals (e.g., mice) or themselves or outsourced to universities or Contract Research
Organisations (CRO).

25 According to documents published by the Shenzhen Municipal Government, the biomedical industry can be broadly defined to encompass conventional drugs, advanced medical devices,
the integration of bioinformatics and information technologies, bioengineering, etc.
26 Pharmacodynamics studies the effects of drugs on the body; pharmacokinetics studies how drugs change in the body, including their absorption, distribution, metabolism and excretion;
toxicology study seeks to understand drug exposure and toxic reactions.
27 In 1992, the Organisation for Economic Co-operation and Development (OECD) formulated the most influential set of GLP guidelines which became the basis on which different countries
adapted and optimised their own guidelines. China’s GLP for Non-Clinical Laboratory Studies guidelines came into effect on 1 September 2017.
28 In 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formulated the GCP guidelines, which became the standards on
which different countries adapted and optimised their own guidelines. China’s newly-revised GCP came into effect on 1 July 2020.
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