Bioequivalence and Bioavailability Forum • Formal ICH Procedure

Formal ICH Procedure [BE/BA News]

posted by Helmut – Vienna, Austria, 2024-08-09 11:45 (124 d 18:57 ago) – Posting: # 24145
Views: 3,726

Dear all,

what I wrote above is wrong. According to the ICH:

[image]

Step 4: Adoption of an ICH Harmonised Guideline
Step 4 is reached when the Assembly agrees that there is sufficient consensus on the draft Guideline.
The Step 4 Final Document is adopted by the ICH Regulatory Members of the ICH Assembly as an ICH Harmonised Guideline at Step 4 of the ICH process.

Step 5: Implementation
Having reached Step 4, the harmonised Guideline moves immediately to the final step of the process that is the regulatory implementation. This step is carried out according to the same national/regional procedures that apply to other regional regulatory guidelines and requirements, in the ICH regions.
(My emphasis)

Although a guideline is in implementation, it is not necessarily implemented in all regions.

Even in regions where a guideline was implemented, it might lead into trouble. If one uses the link to the EMA’s BMV guideline of 2011, it states unambiguously that it has been superseded by the ICH’s M10. However, the FDA’s guidance of 2018 is still accessible and the M10 implemented guidance of 2022 is somewhere else. That’s a trap.

Edit: M13A was adopted by the EMA’s CHMP on 25 July 2024 and will be effective with 25 January 2025 (see this post for details).

—
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Helmut Schütz

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Science Quotes

Complete thread:

ICH M13A: Changes to Step 2 Helmut 2024-07-31 13:16
- ICH M13A: Changes to Step 2 Helmut 2024-07-31 14:19
  - AUCres mittyri 2024-08-05 21:08
    - ‘Percentage covered’ Helmut 2024-08-05 22:13
  - ICH M13A: Changes to Step 2 BEQool 2024-09-09 05:48
    - fixed or mixed effects model Helmut 2024-09-09 07:04
      - fixed or mixed effects model BEQool 2024-09-09 10:18
        
        fixed or mixed effects model Helmut 2024-09-09 11:13
        
        fixed or mixed effects model BEQool 2024-09-10 07:35
      - fixed or mixed effects model Helmut 2024-09-10 08:12
- ICH M13A: Changes to Step 2 Helmut 2024-08-05 12:53
- period within group and formulation mittyri 2024-08-05 20:42
  - period within group and formulation Helmut 2024-08-05 22:29
- ICH M13A: Step 4 → 5 Helmut 2024-08-08 11:57
  - Formal ICH ProcedureHelmut 2024-08-09 09:45
- ICH M13A: Changes to Step 2 Helmut 2024-09-06 08:04