Module 5 Presentations

18/07/2024

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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CMC Items in CTN

- For NCEs,

- potential mutagenic impurities

- For biologics, - PMDA requests provision of information regarding compliance of animal or human derived raw material with Japanese Standards - Viral safety - Control of impurities Note: A different salt is regarded as a different API in Japan. If the salt is changed, a new CTN is necessary

Distribution to third parties is not allowed

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