Module 3 Presentations

07/05/2024

Directives / Regulations for IMP

UK: Medicines for Human Use (Clinical Trials) Regulations 2004, as amended • Based on EU Clinical Trial Directive 2001/20/EC • UK are no longer in the EU the EU CTR does not apply to the UK • Amended by the EU exit regulations US :

• 21 CFR parts 210 & 211, except Ph I • Guidance for Industry documents

The Organisation for Professionals in Regulatory Affairs

7

7

Manufacturing, the QP & cGMP

EudraLex - Volume 4

The Organisation for Professionals in Regulatory Affairs

8

4