Module 5 Presentations

18/07/2024

CT Legislation

The Organisation for Professionals in Regulatory Affairs

11

History of Legislation:

• In the US clinical trial supply controlled under GMP since 1978

• In Europe, Guidelines (Annex 13) introduced in early 1990s but voluntary

• The EU Clinical Trial Directive (2001/20/EC) was published April 2001, enacted in MS law from May 2004

The Organisation for Professionals in Regulatory Affairs

12

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