Before revision: Legal and regulatory status European Union: In the EU, Good Clinical Practice (Directive 2001/20/EC) is backed and regulated by formal legislation contained in the Clinical Trial Directive (Officially Directive 2001 / 20/EC) .
After revision: Legal and regulatory status European Union: In the EU, Good Clinical Practice (Directive 2001/20/EC) is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536 /