Information related to the NCE approval of tafenoquine succinate

Jane Quinn made this Freedom of Information request to Therapeutic Goods Administration

The request was partially successful.

From: Jane Quinn

Delivered

Dear Therapeutic Goods Administration,

The new chemical entity (NCE) 'tafenoquine succinate' has recently been approved for registration as a schedule 4 substance on the TGA Poisons Register with effect from 1 February 2018.

Regarding this pre-registration and registration application information pertaining to the registration of tafenoquine succinate, clease can you provide the following information regarding this Schedule 4 approval, and the NCE application (the registration application and pre-submission documents) from which this approval was given:

1. The number and nature of all adverse event reports a) submitted for tafenoquine to the TGA adverse events database, and b) the number and nature of those adverse event reports considered at part of the delegates application review process;

2. The detailed consumer (patient) information statements submitted a) as part of the registration application and b) those approved for tafenoquine succinate including dose rates and treatment schedules;

3. All information in the application for registration and / or pre-registration documentation relating to requirements for cytochrome P450 (CYP450) screening in patients prior to treatment with tafenoquine succinate, either for prophylaxis or treatment of malaria.

This is the second iteration of this request. I hope that your department will be able to furnish me with this information.

As this information is not for commercial use and represents a public interest inquiry, I ask that the fees associated with this process be waived.

Yours faithfully,

Dr Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Quinn
 
I am writing in relation to the scope of your FOI request FOI275-1718.
Can you please clarify if you are seeking 'personal information' (e.g.,
the names and/or contact details of any individuals, or any information
that could reasonable identify an individual) of third parties contained
in the documents requested?
Confirmation from you that you are not seeking personal information may
enable more timely and less costly processing of your request.  For
example, consultation with identified individuals can add to the time and
cost taken to process your request.
 
If you are not seeking access to personal information, you can simply
reply: 'no personal information requested'.
 
In relation to departmental staff, we advise the standard approach is that
Commonwealth employee names and contact details below Senior Executive
Service level and mobile telephone numbers of all staff are not released.
 
We look forward to hearing from you by COB Friday 13 April 2018.
 
Kind regards
Karen
 
Freedom of Information
Jodie | Karen | Heather | Shreya
(02) 6232 8720
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
 
 
 
 
 

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From: Jane Quinn

Delivered

Dear TGA FOI,

Many thanks for your response.
I can confirm that no personal information is required.

Yours sincerely,

Jane Quinn

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From: FOI
Therapeutic Goods Administration

Attention: Jane Quinn

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has received your request (in your below email) for access to documents under the Freedom of Information Act 1982 (FOI Act).

The Department will take all reasonable steps to notify you of a decision no later than 30 calendar days after the date your request was received. You will be contacted where a charge is applied for processing your request or if we need to consult a third party.

Unless you advise otherwise, duplicate documents and Commonwealth employee names and contact details below Senior Executive Service level and mobile telephone numbers of all staff will be excluded from the scope of your request under s22(1)(a)(ii) of the FOI Act.

You can contact the FOI Unit on (02) 6289 1666, or via email at [email address], should you have any enquiries.

Regards
FOI Unit

Legal Advice & Legislation Branch
Legal & Assurance Division
Australian Government Department of Health
T: (02) 6289 1666 | E: [TGA request email]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health acknowledges the traditional owners of country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to elders both past and present.

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From: TGA FOI
Therapeutic Goods Administration


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Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

As set out in the attached correspondence, we seek your response within 14
days, being 17 May 2018.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

Jodie

 

Jodie Russell | Karen Bedford | Heather Davidson | Tara Condon

HPRG Regulatory Information Access

[1]cid:image002.png@01D3B7B3.BF8638F0

Reporting & Collaboration Services| Regulatory Engagement & Planning
Health Products Regulation Group

Australian Government Department of Health

 

T: 02 6232 8720  | 02 6232 8772 | 02 6232 8012 | 02 6232 8826 | E:
[2][email address]

Location: Symonston, GE26

 

PO Box 100, Canberra ACT 2601, Australia

 

The Department of Health acknowledges the traditional owners of country
throughout Australia, and their continuing connection to land, sea and
community. We pay our respects to them and their cultures, and to elders
both past and present.

 

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From: Quinn, Jane


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Dear Mr McDonald,

 

With reference to your letter of 3^rd May 2018, please can you amend my
request to include only the following parameter:

 

1.       The number and nature of all adverse event reports a) submitted
for tafenoquine to the TGA adverse events database, and b) the number and
nature of those adverse event reports considered as part of the delegates
application review process.

 

I confirm again that all information can be anonymized, I do not request
any individual to be identified in this information.

 

I look forward to your acknowledgement of receipt of this email, and a
response to my FOI inquiry.

 

Kindest regards,

 

Jane

 

Associate Professor Jane Quinn

Associate Dean Research (Acting), Faculty of Science

Charles Sturt University

Boorooma Street

Wagga Wagga NSW 2701

Tel: +61 (0)2 69334208

Email: [1][email address]

[2]CSU_Logo Mark_CMYK

 

[3]Charles Sturt University

|   ALBURY-WODONGA   |   BATHURST   |   CANBERRA   |   DUBBO   |   GOULBURN   |   MELBOURNE   |   ORANGE   |   PORT
MACQUARIE   |   SYDNEY   |   WAGGA WAGGA   |

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From: Jane Quinn

Delivered

Dear TGA FOI,

I have responded to the email address identified in your letter of 3 May 2018 with the information below. The date today is 11 May.

Dear Mr McDonald,

With reference to your letter of 3rd May 2018, please can you amend my request to include only the following parameter:

1. The number and nature of all adverse event reports a) submitted for tafenoquine to the TGA adverse events database, and b) the number and nature of those adverse event reports considered as part of the delegates application review process.

I confirm again that all information can be anonymized, I do not request any individual to be identified in this information.

I look forward to your acknowledgement of receipt of this email, and a response to my FOI inquiry.

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration

Dear Ms Quinn,

Thank you for your email of 11 May 2018.

Following further consultation with the relevant line area, we can advise that the revised scope provided by you, as outlined below, is still too voluminous for the TGA to process since the context of what documents would fall within scope has not changed significantly.

Specifically, part b of the revised scope would require manually reviewing dossiers to identify the information you have requested. As advised in our correspondence of 3 May 2018, dossiers generally contain in excess of 100,000 pages and to undertake a review of these documents would unreasonably divert the resources of department staff.

The TGA may be able to provide documents relating to part a of your revised request. We note however, information relating to Adverse Event Reports are publically available on the Database for Adverse Event Notifications (DAEN) website via the following link: https://apps.tga.gov.au/PROD/DAEN/daen-e... .

Based on the above, we would like to provide an additional opportunity for you to consider revising the scope of your request.

Please note, if you indicate that you do not wish to revise your request or you revise it in such a way that the decision maker is still of the view that processing it would substantially and unreasonably divert TGA resources, the decision maker may refuse your request under section 24(1)(b) of the FOI Act.

Pursuant to section 24AB(5) of the FOI Act, the consultation timeframe has been extended until Thursday 24 May 2018, to allow you sufficient time to consider the above.

If you have any questions, please do not hesitate to contact the FOI Team.

Kind regards,

Freedom of Information
(02) 6232 8720
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: Jane Quinn

Delivered

Dear TGA FOI,

I have sent this as an email also:

With reference to your letter of 16 May,

Please can I amend my request to the following:
1. The number and nature of all adverse event reports a) submitted for tafenoquine to the TGA adverse events database.
I am sure you are that tafenqouine succinate is not readily searchable in the TGA database as this drug has only been very recently
I confirm again that all information can be anonymized, I do not request any individual to be identified in this information.
I look forward to your acknowledgement of receipt of this email, and a response to my FOI inquiry.

Yours sincerely,

Jane Quinn

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From: Quinn, Jane


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Dear Mr McDonald,

 

With reference to your letter of 16 May,

 

Please can I amend my request to the following:

1.       The number and nature of all adverse event reports a) submitted
for tafenoquine to the TGA adverse events database.

I am sure you are that tafenqouine succinate is not readily searchable in
the TGA database as this drug has only been very recently

I confirm again that all information can be anonymized, I do not request
any individual to be identified in this information.

I look forward to your acknowledgement of receipt of this email, and a
response to my FOI inquiry.

Yours sincerely,

Jane

 

From: Quinn, Jane
Sent: Friday, 11 May 2018 3:53 PM
To: '[FOI #4475 email]'
<[FOI #4475 email]>
Cc: Quinn, Jane <[email address]>
Subject: Response to letter of 3 May - FOI request 275-1718

 

Dear Mr McDonald,

 

With reference to your letter of 3^rd May 2018, please can you amend my
request to include only the following parameter:

 

1.       The number and nature of all adverse event reports a) submitted
for tafenoquine to the TGA adverse events database, and b) the number and
nature of those adverse event reports considered as part of the delegates
application review process.

 

I confirm again that all information can be anonymized, I do not request
any individual to be identified in this information.

 

I look forward to your acknowledgement of receipt of this email, and a
response to my FOI inquiry.

 

Kindest regards,

 

Jane

 

Associate Professor Jane Quinn

Associate Dean Research (Acting), Faculty of Science

Charles Sturt University

Boorooma Street

Wagga Wagga NSW 2701

Tel: +61 (0)2 69334208

Email: [1][email address]

[2]CSU_Logo Mark_CMYK

 

References

Visible links
1. mailto:[email address]

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From: TGA FOI
Therapeutic Goods Administration


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Dear Dr Quinn

 

Thank you for your email of 21 May 2018.

 

Request consultation process for FOI 275-1718

With respect to the request consultation process that was initiated on 3
May 2018, the decision maker has considered your revised scope of 21 May
2018 and is satisfied that a practical refusal reason no longer exists. We
will therefore process your request as revised on 21 May 2018, being for
‘The number and nature of all adverse event reports submitted for
tafenoquine to the TGA adverse events database.’

 

Charges for FOI 275-1718

The decision maker has decided not to impose any charges for your new FOI
request of 9 April 2018.

 

A decision on your new request will be due to you on or before 27 May
2018.

 

However, we note the FOI Guidelines provide, at paragraph 3.141, that if
the last day for notifying a decision falls on a Saturday, Sunday or a
public holiday, the timeframe will expire on the first business day
following that day. Accordingly, as the due date is a Sunday and the
following day is a public holiday, a decision will be due to you on or
before Tuesday 29 May 2018.

 

If you have any questions, please do not hesitate to contact the FOI team.

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

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From: Jane Quinn

Delivered

Dear TGA FOI,

Further to your message of 24 May, I did not receive a reply to my FOI request on 29 May as advised.

Please can you advise exactly when I will be furnished with a response to my request?

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration

Dear Dr Quinn,

The TGA has been attempting to send you a Notice of Decision in relation to your FOI request, FOI275-1718, since 29 May 2018. However, we are continually receiving a delayed receipt, indicating that your email server cannot be reached.

We’d be grateful if you could please provide an alternate email address which we can send the Notice of Decision to, or alternatively, contact the FOI Team on the below number to provide another method of contact.

Kind regards,

Freedom of Information
(02) 6232 8720
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: TGA FOI
Therapeutic Goods Administration


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Attachment ATTACHMENT B.pdf
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Attachment Review Rights.pdf
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Attachment FOI275 1718 Notice of Decision.pdf
449K Download View as HTML

Attachment Document 1 AR.pdf
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Attachment D18 10569418 FOI275 1718 Schedule of Relevant Documents Final.PDF.pdf
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Dear Dr Quinn

 

I am resending the email below as we received an email on 30 May 2018
stating that there was an issue delivering the email.

 

We received another email on 1 June 2018 again stating that there was an
issue delivering the email.

 

This is our third attempt to send you a decision for your FOI request
275-1718 that was originally sent to you on Tuesday 29 May 2018.

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

 

From: TGA FOI
Sent: Tuesday, 29 May 2018 4:36 PM
To: 'Jane Quinn'
Cc: TGA FOI
Subject: FOI275-1718 - Notice of Decision [SEC=UNCLASSIFIED]

 

Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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From: TGA FOI
Therapeutic Goods Administration


Attachment image001.png
3K Download

Attachment ATTACHMENT B.pdf
59K Download View as HTML

Attachment Review Rights.pdf
1.1M Download View as HTML

Attachment FOI275 1718 Notice of Decision.pdf
449K Download View as HTML

Attachment Document 1 AR.pdf
61K Download View as HTML

Attachment D18 10569418 FOI275 1718 Schedule of Relevant Documents Final.PDF.pdf
32K Download View as HTML


Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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From: TGA FOI
Therapeutic Goods Administration


Attachment image001.png
3K Download

Attachment ATTACHMENT B.pdf
59K Download View as HTML

Attachment Review Rights.pdf
1.1M Download View as HTML

Attachment FOI275 1718 Notice of Decision.pdf
449K Download View as HTML

Attachment Document 1 AR.pdf
61K Download View as HTML

Attachment D18 10569418 FOI275 1718 Schedule of Relevant Documents Final.PDF.pdf
32K Download View as HTML


Dear Dr Quinn

 

I am resending the email below as we received an email stating that there
was an issue delivering the email.

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

From: TGA FOI
Sent: Tuesday, 29 May 2018 4:36 PM
To: 'Jane Quinn'
Cc: TGA FOI
Subject: FOI275-1718 - Notice of Decision [SEC=UNCLASSIFIED]

 

Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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