Japan: English Translation of First-in-Human Studies Guidance Released
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is announcing the publication of an English translation of a guidance document detailing how first-in-human studies are to be conducted.
The Guidance, Establishing Safety in First-in-Human Studies during Drug Development, provides PMDA's advice on how to facilitate "the smooth transition from non-clinical to early clinical study during the drug development process."
It applies to new chemical and biological/biotech investigational drugs, but not to investigational drugs for cellular, tissue and gene therapy. The guidance identifies risk factors, discusses product quality, and advises on the planning and implementation of nonclinical studies and first-in-human trials.
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PMDA - Establishing Safety in First-in-Human Studies during Drug Development