Helmut
★★★
avatar
Homepage
Vienna, Austria,
2022-12-23 10:05
(476 d 05:36 ago)

Posting: # 23409
Views: 4,268
 

 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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Rasha_J
☆    

Jordan,
2023-01-16 06:27
(452 d 09:13 ago)

@ Helmut
Posting: # 23422
Views: 3,300
 

 ICH M13A (IR BE)

Thank you for the updates
Is there a link to submit comments
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2023-01-16 10:19
(452 d 05:21 ago)

@ Rasha_J
Posting: # 23423
Views: 3,260
 

 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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
SMA
☆    

Europe,
2023-01-17 10:30
(451 d 05:10 ago)

@ Rasha_J
Posting: # 23424
Views: 3,284
 

 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
(451 d 02:38 ago)

@ Rasha_J
Posting: # 23426
Views: 3,165
 

 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
(450 d 04:47 ago)

@ Rasha_J
Posting: # 23429
Views: 3,157
 

 ICH M13A (IR BE)

Thank you for all :-)
Ohlbe
★★★

France,
2023-02-01 15:14
(436 d 00:26 ago)

@ Rasha_J
Posting: # 23437
Views: 2,880
 

 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
★★★
avatar
Homepage
Vienna, Austria,
2023-02-09 13:34
(428 d 02:07 ago)

@ Ohlbe
Posting: # 23449
Views: 2,677
 

 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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
SMA
☆    

Europe,
2023-02-08 10:10
(429 d 05:31 ago)

@ Helmut
Posting: # 23446
Views: 2,685
 

 ICH M13A (IR BE): EMA consultation

Dear All

EMA consultation launched.
Comments must be submitted by 26 May 2023
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2023-09-18 12:54
(207 d 03:47 ago)

@ SMA
Posting: # 23719
Views: 1,541
 

 ICH M13A (IR BE): EMA comments received

Dear SMA & all,

Overview of comments received (48 pages).

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,980 posts in 4,821 threads, 1,657 registered users;
47 visitors (0 registered, 47 guests [including 14 identified bots]).
Forum time: 16:41 CEST (Europe/Vienna)

Never, never, never use any software!
Never, never, never trust any computer!    Detlew Labes

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5