Module 9 2024

03/09/2024

Key Future Changes to Monitor

• There are a number of potential changes in legislation and expectations which you should continue to monitor in this space including but not limited to: • EU New Pharmaceutical Legislation – likely to significantly change EU lifecycle variation requirements but also may introduce opportunities such • ICH M4Q new revision – likely to significantly change CTD structure and content (continue to monitor ICH for updates - ICH Official web site : ICH) • Increasing global focus on reliance, haromisation etc (e.g. International Coalition of Medicines Regulatory Authorities (ICMRA) pilots - Statement from Global Medicines Regulators on the Value of Regulatory Reliance | International Coalition of Medicines Regulatory Authorities (ICMRA)) as ICH Q12 adoption, platform master files etc (Reform of the EU pharmaceutical legislation - European Commission (europa.eu))

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Thank you for your attention!

Any Questions?

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