CRED Getting the CMC Dossier Right 2024

28/08/2024

Specific Quality Requirements – separate EMA guidelines are available for biological medicinal products

Biological products: www.emea.europa.eu/htms/human/humanguidelines/biologicals.htm

Multidisciplinary guidelines: https://www.ema.europa.eu/en/human-regulatory/research development/scientific-guidelines/multidisciplinary-guidelines

Bioequivalence Guideline for Locally Applied, Locally Acting drug products: https://www.ema.europa.eu/en/equivalence-studies-demonstration-therapeutic-equivalence-locally applied-locally-acting-products

Draft Guideline Bioequivalence topical products: https://www.ema.europa.eu/en/quality equivalence-topical-products

Medical devices: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Veterinary guidelines: https://www.ema.europa.eu/en/veterinary-regulatory/research development/scientific-guidelines/quality/quality-non-immunologicals & https://www.ema.europa.eu/en/veterinary-regulatory/research-development/scientific guidelines/immunologicals-guidelines

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

37

Thank you for your attention

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

38