ICH pushed by GBHI? [BE/BA News]

posted by Ohlbe – France, 2019-11-28 14:06  – Posting: # 20884
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Dear Helmut,

» » It will be interesting to see if they will then harmonize the definition of BE. That little subtle difference between EMA's and FDA's definition makes all the difference between allowing PD to be part of a BE proof, or whether that should rather be called TE with all it entails in relation to the discussion of 10.3's, 10.1/10.2's, 505(b)(2)'s, 505(j)'s and so forth.
»
» Agree – the major obstacle will be the legal stuff.

Don't you expect some lengthy discussions regarding HVD, two-step design, NTID, fed/fasting/both, supporting data from metabolites and stuff like that ? Aren't these significant differences between both sides of the Atlantic ?

» My impression: ICH-members felt the pressure coming from the GBHI-conferences (Mar 2015 Amsterdam, Sep 2016 Rockville, Apr 2018 Amsterdam).
» Biowaivers and IR were topics of the the first two.
  • The ICH’s concept paper on biowaivers was published in Oct 2016 and the draft in Oct 2018.

Final guideline (Step 4) adopted at the last meeting, according to the press release you linked in your first message.

Regards
Ohlbe

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