Helmut
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Vienna, Austria,
2022-12-23 10:05
(543 d 07:04 ago)

Posting: # 23409
Views: 4,746
 

 ICH M13A (IR BE) [BE/BA News]

Dear all,

the ICH Draft Guideline Bioequivalence for Immediate-Release Solid Oral Dosage Forms (M13A Step 2) was published yesterday.

Note the new terminology: A – C instead of Tier 1 – 3 mentioned in the Concept Paper.

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Rasha_J
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Jordan,
2023-01-16 06:27
(519 d 10:41 ago)

@ Helmut
Posting: # 23422
Views: 3,714
 

 ICH M13A (IR BE)

Thank you for the updates
Is there a link to submit comments
Helmut
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Vienna, Austria,
2023-01-16 10:19
(519 d 06:49 ago)

@ Rasha_J
Posting: # 23423
Views: 3,674
 

 ICH M13A (IR BE)

Hi Rasha,

❝ Is there a link to submit comments


As of today the guideline is not published by the EMA, FDA, and Health Canada. Too lazy to search other regions. I will keep you informed.

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SMA
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Europe,
2023-01-17 10:30
(518 d 06:38 ago)

@ Rasha_J
Posting: # 23424
Views: 3,704
 

 ICH M13A (IR BE)

Dear Rasha_J

Public consultations are launched regionally.
You can track who has launched the consultation by accessing the ICH multidisciplinary guideline, and clicking the link within M13.

So far, only TFDA Chinese Taipei has launched their consultation.

Public consultation dates:
TFDA, Chinese Taipei - Deadline for comments by 30 April 2023

❝ Is there a link to submit comments


Links to submit comments are made available by regional agencies once they open their consultation process.

The more the scientific community contributes to the consultations (and use data to support recommendations, where possible), the better the chances that the ICH Expert Working Group can address the points.

Best
dshah
★★  

India/United Kingdom,
2023-01-17 13:02
(518 d 04:06 ago)

@ Rasha_J
Posting: # 23426
Views: 3,590
 

 ICH M13A (IR BE)

Hi Rasha_J!

Below information might be helpful:

"stakeholders from ICH Member countries/regions are encouraged to submit their comments to their respective Regulatory Authorities, noting the deadline for comments indicated beneath each draft Guideline.

Stakeholders can also provide their comments by e-mailing the ICH Secretariat at [email protected]. For this purpose please make sure to use the ICH Template in Excel format. https://admin.ich.org/sites/default/files/2020-12/ICH_PublicConsultationComments_Template_Stakeholders_2020_1014.xlsx

Please note that comments provided to the ICH Secretariat will be shared with the appointed participants of the relevant ICH Working Group responsible for the development of draft documents submitted to consultation."

Regrards,
Divyen
Rasha_J
☆    

Jordan,
2023-01-18 10:53
(517 d 06:15 ago)

@ Rasha_J
Posting: # 23429
Views: 3,577
 

 ICH M13A (IR BE)

Thank you for all :-)
Ohlbe
★★★

France,
2023-02-01 15:14
(503 d 01:54 ago)

@ Rasha_J
Posting: # 23437
Views: 3,304
 

 ICH M13A (IR BE) : FDA web site

Dear Rasha,

❝ Is there a link to submit comments


Posted yesterday on the FDA website !

Regards
Ohlbe
Helmut
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Vienna, Austria,
2023-02-09 13:34
(495 d 03:35 ago)

@ Ohlbe
Posting: # 23449
Views: 3,094
 

 Knowledge is power…

Dear Ohlbe & all,

two weeks ago the FDA’s CDER Small Business and Industry Assistance (SBIA) started a poll at LinkedIn. The question was:

True or False: ICH Guidelines are developed through scientific consensus between international regulatory experts only.

31% (‼) of the 425 participants answered TRUE. Amazing.

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SMA
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Europe,
2023-02-08 10:10
(496 d 06:59 ago)

@ Helmut
Posting: # 23446
Views: 3,113
 

 ICH M13A (IR BE): EMA consultation

Dear All

EMA consultation launched.
Comments must be submitted by 26 May 2023
Helmut
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Vienna, Austria,
2023-09-18 12:54
(274 d 05:15 ago)

@ SMA
Posting: # 23719
Views: 1,951
 

 ICH M13A (IR BE): EMA comments received

Dear SMA & all,

Overview of comments received (48 pages).

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