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# 2 ICH Guidelines Advance
- URL: https://www.fdaweb.com/2-ich-guidelines-advance/
- Published: 2025-03-19T12:00:00.000Z
- Updated: 2026-09-14T14:55:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158855

The International Council for Harmonization (ICH) says two of its guidelines have reached Step 2b of the ICH process. The [M11](https://www.ich.org/news/ich-m11-updated-technical-specification-document-now-available-ich-website?ref=fdaweb.com) updated technical specification document, incorporating comments received during the first public consultation, has entered the second round of public consultation, which will focus solely on the technical specification document.

The [M13B](https://www.ich.org/news/ich-m13b-draft-guideline-step-2-presentation-now-available-ich-website?ref=fdaweb.com) draft guideline on “Bioequivalence for Immediate-Release Solid Oral Dosage Forms — Additional Strengths Biowaiver” is in the public consultation period. ICH says a Step 2 informational presentation has been developed by the M13B working group and is available on the ICH Web site.