Module 1 2021

28/06/2021

GMP Requirements

Investigational Medicinal Products should be manufactured following GMP standards

In Japan, GMP related documents are not required for Clinical Trial Application. Only basic quality information is needed. PMDA trusts it is the Sponsor’s responsibility to ensure IMP is GMP compliant

In EU, need to provide extensive data on quality attributes of IMP and GMP evidence

Distribution to third parties is not allowed

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Quality Aspects of Investigational Medicinal Product

Principles of IMP-GMP (PFSB No.70, 1997)

- To assure the quality of the IMP and thus protect subjects of clinical trials from poor-quality products

- To assure consistency between and within batches of the IMP and thus assure the reliability of clinical trials - To assure consistency between the IMP and the future commercial product and thus assure the efficacy and safety of the marketed product

Distribution to third parties is not allowed

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