Clinical Development of Investigational New Drug

In previous chapters, the different requirements of regulatory submission for various drug categories and classes were discussed. Even though the classification of new drugs (both local and imported) follows the same regulation, the clinical development strategies or plans can differ. For multinational pharmaceutical companies, they may use International Multicenter Clinical Trials (IMCT) or Multi-regional Clinical Trials (MRCT) strategies to apply for import drug license (IDL). These development strategies share global drug development resources, synchronize drug research and development progress globally, and shorten the time gaps in drug marketing among different countries. Apart from these differences in clinical development strategies, the requirements for clinical trials are also different from those of the western countries. These differences include: patient sample sizes for various clinical phases have to follow the CFDA’s defined requirements; the investigator’s responsibilities and safety reporting requirements are very unique from those of the western world; all the clinical sites and investigators have to be certified by the CFDA to conduct the clinical trials; all ethics committees (EC) have to follow the CFDA’s Guidance for Ethical Review of Investigational Drug Clinical Trials. In this chapter, the above topics will be discussed.