CRED SMPC 2024

23/09/2024

SmPC evolution of guidance updates

• 2017, Jan: EMA Scientific Guidelines with SmPC recommendations

• 2019, Oct, EMA guidance document: Wording of therapeutic indication A Guide for Assessors of Centralised Applications

• 2019 Nov update: European Commission Excipient guidelines

• CMDh – product information recommendations

• 2024, Jan: Scientific guidelines

The Organisation for Professionals in Regulatory Affairs

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Why SmPC Guidance Revision?

● To ensure reflection of latest scientific knowledge, regulatory requirements and safety information ● Changes in legislation and guidance – Paediatric Regulation (2007) – Risk Management Plans – Pharmacovigilance – Pharmacogenomic data

● Medical progress and new therapies

The Organisation for Professionals in Regulatory Affairs

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