Regulatory Open Forum

Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

Alison,

Since 2008, CDER has required that sponsors of new marketing applications (ANDAs, BLAs, NDAs, INDs), and related submissions (master files, advertising material and promotional labeling), including original submissions, supplements, annual reports, and amendments to the applications submitted electronically be in eCTD format. Of course there is no requirement to submit electronically but it is recommended.

CBER does not require electronic submissions (eCTD).

However, it is expected the agency will eventually require electronic submissions, but the implementation date for the requirement has not been officially announced.

-------------------------------------------
Sarah Powell RAC
Executive Director, Regulatory Strategies
Liquent
Granite Bay CA
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

The PDUFA V legislation working through the US House of Representatives proposes a timeframe for mandating eCTD for BLAs and NDAs in 2015-2016 timeframe and all INDs (except single-patient compassionate use) 12 months later.

The GDUFA I legislation proposes mandating eCTD for ANDAs and Type II DMFs approx. 24 months following initial authorization but implies if ANDAs are submitted in eCTD format starting Oct 1 that their review will be completed under  the GDUFA timeline vs no timeline under current review practices. (Backlog of ANDAs to be reviewed is 30-40 months).

Some of the above is my opinion following reading of Commitment Letters written by FDA and regulated industry following many months of negotiation and input from a large range of stakeholders including patient advocacy, consumers, healthcare industry, etc.

-------------------------------------------
Antoinette Azevedo
President & CEO
e-SubmissionsSolutions.com
San Diego CA
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

I was interested in your comment:  "The GDUFA I legislation proposes mandating eCTD for ANDAs and Type II DMFs approx. 24 months following initial authorization but implies if ANDAs are submitted in eCTD format starting Oct 1 that their review will be completed under  the GDUFA timeline vs no timeline under current review practices."

I have a colleage who has had input with GDUFA and he was suprised with this comment when I passed it along, he said that when this was discussed with FDA during the GDUFA negotiation,  this provision had been specifically tabled at that point. 

We are wondering if it worked its way back into the bill. Could you point out in the bill where this provision is stated?   

thanks

-------------------------------------------
Debbie Gumpert
Regulatory Affairs Specialist
Albemarle Corporation
South Haven MI
United States
-------------------------------------------






Original Message:
Sent: 05-08-2012 10:11
From: Antoinette Azevedo
Subject: eCTD Requirements


The PDUFA V legislation working through the US House of Representatives proposes a timeframe for mandating eCTD for BLAs and NDAs in 2015-2016 timeframe and all INDs (except single-patient compassionate use) 12 months later.

The GDUFA I legislation proposes mandating eCTD for ANDAs and Type II DMFs approx. 24 months following initial authorization but implies if ANDAs are submitted in eCTD format starting Oct 1 that their review will be completed under  the GDUFA timeline vs no timeline under current review practices. (Backlog of ANDAs to be reviewed is 30-40 months).

Some of the above is my opinion following reading of Commitment Letters written by FDA and regulated industry following many months of negotiation and input from a large range of stakeholders including patient advocacy, consumers, healthcare industry, etc.

-------------------------------------------
Antoinette Azevedo
President & CEO
e-SubmissionsSolutions.com
San Diego CA
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

Hi Alison,
My understanding is:

1Q-2016 for sponsors, applicants, and manufacturers submitting BLAs and NDAs
1Q-2017 for all commercial INDs and amendments, except section 561 submissions

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

There doesn't seem to be any deadline drop date set yet by FDA for switching to eCTD but the Agency encourages to file the submission using eCTD
-------------------------------------------
Hemant Goswami
Sr Proj Mgr
GlaxoSmithKline, Inc
Research Triangle Park NC
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

Title VII, Section 603 of the bill being marked up by the House of Representatives this week calls for mandatory electronic submissions for NDA, BLA, IND, ANDA, Type II DMFs, all device submissions, and biosimilar submissions.  Timeframe is 24 months after issuance of final guidance.  There will be provisions for exemptions.

Does not specifically call for eCTD, but the FDA commitment letters that contained the results of negotiations between FDA and regulated industry did call out eCTD for drugs & biologics, and electronic copy for devices (similar to eCTD without XML backbone).

Check out announcements on the House Energy and Commerce Committee web site.

The Majority Memorandum summarizing the bill describes this section as: "Section 603: This section would require electronic submission of drug, generic drug, biologic, and biosimilar applications following issuance of a final guidance by the Secretary."

Let me know if you want copies of the draft bill and the majority memorandum.



-------------------------------------------
Antoinette Azevedo
President & CEO
e-SubmissionsSolutions.com
San Diego CA
United States
-------------------------------------------






Original Message:
Sent: 05-09-2012 12:00
From: Hemant Goswami
Subject: eCTD Requirements

There doesn't seem to be any deadline drop date set yet by FDA for switching to eCTD but the Agency encourages to file the submission using eCTD
-------------------------------------------
Hemant Goswami
Sr Proj Mgr
GlaxoSmithKline, Inc
Research Triangle Park NC
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

Hi Antoinette,

Yes, could you send me a copy?

Thanks

-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------






Original Message:
Sent: 05-10-2012 08:30
From: Antoinette Azevedo
Subject: eCTD Requirements

Title VII, Section 603 of the bill being marked up by the House of Representatives this week calls for mandatory electronic submissions for NDA, BLA, IND, ANDA, Type II DMFs, all device submissions, and biosimilar submissions.  Timeframe is 24 months after issuance of final guidance.  There will be provisions for exemptions.

Does not specifically call for eCTD, but the FDA commitment letters that contained the results of negotiations between FDA and regulated industry did call out eCTD for drugs & biologics, and electronic copy for devices (similar to eCTD without XML backbone).

Check out announcements on the House Energy and Commerce Committee web site.

The Majority Memorandum summarizing the bill describes this section as: "Section 603: This section would require electronic submission of drug, generic drug, biologic, and biosimilar applications following issuance of a final guidance by the Secretary."

Let me know if you want copies of the draft bill and the majority memorandum.



-------------------------------------------
Antoinette Azevedo
President & CEO
e-SubmissionsSolutions.com
San Diego CA
United States
-------------------------------------------






Original Message:
Sent: 05-09-2012 12:00
From: Hemant Goswami
Subject: eCTD Requirements

There doesn't seem to be any deadline drop date set yet by FDA for switching to eCTD but the Agency encourages to file the submission using eCTD
-------------------------------------------
Hemant Goswami
Sr Proj Mgr
GlaxoSmithKline, Inc
Research Triangle Park NC
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

For FDA, it will be only eCTD by 2017>
-------------------------------------------
Esther Hendrickson
Manager, Regulatory Affairs
Ludwig Institute For Cancer Research
New York NY
United States
-------------------------------------------






Original Message:
Sent: 05-09-2012 12:00
From: Hemant Goswami
Subject: eCTD Requirements

There doesn't seem to be any deadline drop date set yet by FDA for switching to eCTD but the Agency encourages to file the submission using eCTD
-------------------------------------------
Hemant Goswami
Sr Proj Mgr
GlaxoSmithKline, Inc
Research Triangle Park NC
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

For new applications FDA will require eCTD format is what I am taking from this discussion.  My experience with the generic side involved being able to switch to eCTD format even though the original application with followup submissions were not converted.  If I remember correctly I think we had to contact FDA to get a waiver for the transition from hard copy to eCTD format before doing so.  Is that correct?  

We are a very small company and although we have submitting applications in CTD format I have been talking about eCTD requirements so these dates will help us plan. 

Thanks for your help. 

-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------






Original Message:
Sent: 05-10-2012 08:48
From: Esther Hendrickson
Subject: eCTD Requirements


For FDA, it will be only eCTD by 2017>
-------------------------------------------
Esther Hendrickson
Manager, Regulatory Affairs
Ludwig Institute For Cancer Research
New York NY
United States
-------------------------------------------






Original Message:
Sent: 05-09-2012 12:00
From: Hemant Goswami
Subject: eCTD Requirements

There doesn't seem to be any deadline drop date set yet by FDA for switching to eCTD but the Agency encourages to file the submission using eCTD
-------------------------------------------
Hemant Goswami
Sr Proj Mgr
GlaxoSmithKline, Inc
Research Triangle Park NC
United States
-------------------------------------------






Original Message:
Sent: 05-07-2012 17:03
From: Alison Trado
Subject: eCTD Requirements


Hello all..

Has FDA provided notice on the date as to when ALL pharmaceutical companies are required to submit in eCTD format? 

Thank you.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------