CRED Getting the CMC Dossier Right 2024

29/08/2024

Assessment

Research

Decision

Dossier

Assessment

Be aware of differences between CA!

The EMA has produced a short video to illustrate this: EMA From lab to patient – YouTube (1min23)

The Organisation for Professionals in Regulatory Affairs

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Assessment

HMRs 2012 & Directive 2001/83/EC

(2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health .

(3) However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.

SAFETY

QUALITY

EFFICACY

We need to be convinced of a positive “benefit to risk ratio”.

The Organisation for Professionals in Regulatory Affairs

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