Module 3 2019

Directives / Regulations for IMP (2)

EU Continued – the future: 536/2014 – Clinical trials regulation IMP elements of 2003/94/EC and 2005/28/EC are included in the CTR ● Will come into force 6 months after the new portal and database is working (no earlier than 28 May 2016) ● Current timelines on EMA website – ‘During 2020’ ● Ongoing trials have 3 years to convert to new regulation GMP for IMP delegated regulation, (EU) 2017/1569, will be implemented at the same time

The Organisation for Professionals in Regulatory Affairs

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