CRED Getting the CMC Dossier Right 2024

28/08/2024

More detailed back ups

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Draft guidance – useful references

ICH :

Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

EMA:

Reflection paper on the chemical structure and properties 4 criteria to be considered for the evaluation of New Active 5 Substance (NAS) status of chemical substances

Guideline on the chemistry of active substances

FDA: Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products - May 2015

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