Q&A 21 : Can you please comment about the FDA release of E6(R2) March 2018, and why section 9. Paperwork Reduction Act of 1995 was added?

“Can you please comment about the FDA release of E6(R2) March 2018, and why 9. Paperwork Reduction Act of 1995 was added. Also why does the ich.org not even have this version posted? “

FDA Version of E6 R2 Section 9

We don’t claim to be experts on the Paperwork Reduction Act of 1995, but I think in this instance, it is a disclaimer by the FDA as the E6 guidance refers to collection of information which could be collected on paper, which in such circumstances MAY contravene some of the terms in the 1995 Act and the FDA is not advocating this by recognising the e6 guidance. Section 9 in the FDA version does not impact the principles of or intent behind ICH E6 R2.

To the second point, the Paperwork Reduction Act of 1995 is legislation that applies only in the USA and ICH E6 R2 is a global guidance document, section 9 has been added by the FDA not by the ICH Committee and therefore does not appear in the final version published by ICH.

  Tammy Finnegan, COO  tammy.finnigan@tritrials.com

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