Spring Intro 2023

Jenny Lamport

ICH CTD guidelines

 M4 organisation  M4Q quality (rapporteur: EU)  M4S safety (rapporteur: MHLW)  M4E efficacy (rapporteur: FDA)  e CTD (rapporteur: FDA)

Q & A Guidance's

https://www.ich.org/page/ctd

The Organisation for Professionals in Regulatory Affairs

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Implementation in the EU….

Implementing legislation ● Directive 2003/63/EC of 25 June 2003 – Applicable from 1 July 2003 – Revised Annex 1 to 2001/83/EC …CTD format THEREFORE… ● Centralised applications: – 1 July 2003 ● National and new MRP applications: – 31 October 2003

The Organisation for Professionals in Regulatory Affairs

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