For different therapeutic modalities, the non-clinical studies required before applying for clinical trials are not exactly the same and specific guidance (if any) for the distinct therapeutic modality is advised to be followed. For example, the timing and types of non-clinical studies required for the application of clinical trial or marketing authorization of a new chemical entity (NCE) are described in ICH M3(R2) and those required for biotechnology-derived pharmaceuticals are outlined in ICH S6(R1). For the methodology of those non-clinical studies, reference can be made to Taiwan’s 「藥品非臨床試驗安全性規範」(latest version) and the OECD test guidelines. Since the regulatory requirement varies by therapeutic modality, developers are encouraged to prepare sufficient information and specify clear issues to consult with CDE.

(中文版)