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TECHNICAL CONCERNS FOR THE REGISTRATION OF DRUG PRODUCTS (3)

Requested from DOH by SAMMY JAMESON ASCAN at 03:37 PM on Aug 04, 2020.
Purpose: DRUG REGISTRATION
Date of Coverage: 01/01/2020 - 08/04/2020
Tracking no: #DOH-276152494243

SAMMY JAMESON 03:37 PM, Aug 04, 2020

11.	P4.4 is absent in FDA Checklist, and ACTD but present in Citizen’s charter, which one should be followed?
12.	Please confirm if Test and Specification from S4.1, S5 and S7 should have the same parameters/ consistent with each other. P5.1 and P8 should be the same correct? 
13.	Is 25 ± 2ºC 60% ± 5% RH 72 Months acceptable for long term stability testing of API? 
14.	Please confirm if S7 shall not follow the ASEAN Guidelines on Stability of Drugs since ACTD states that Generic products are only required to submit Manufacturer Stability Data or equivalent information.

FOI 04:32 PM, Aug 04, 2020

August 4, 2020

Dear SAMMY JAMESON,

Thank you for your request dated Aug 04, 2020 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for TECHNICAL CONCERNS FOR THE REGISTRATION OF DRUG PRODUCTS (3).

We received your request on Aug 04, 2020 and will respond on or before Aug 25, 2020 03:37:23 PM, in accordance with the Executive Order's implementing rules and regulations.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://www.foi.gov.ph/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0yNzYxNTI0OTQyNDMM, for request with ticket number #DOH-276152494243.

Thank you.

Respectfully,

FOI Receiving Officer

Dr. Kenneth 02:18 PM, Aug 07, 2020

Hi SAMMY JAMESON ASCAN

Please be informed that your request has been endorsed to the Food and Drug Administration for action. Kindly await for their response, thank you

Dr. Kenneth 09:15 PM, Aug 26, 2020

August 26, 2020

Dear SAMMY JAMESON ASCAN,

I refer to my letter of Aug 04, 2020 03:37:23 PM; about your request under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for TECHNICAL CONCERNS FOR THE REGISTRATION OF DRUG PRODUCTS (3).

Our response to your request is due on Aug 25, 2020 03:37:23 PM. Unfortunately, it is taking longer than expected to deal with your request because we have awaited the response from FDA on your inquiry

I apologize for this delay but have applied for an extension so we could work further on your request. We hope to be able to send you a response on or before Sep 22, 2020 03:37:23 PM.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://pcoomaster12222016133000-dot-efoi-ph.appspot.com/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0yNzYxNTI0OTQyNDMM, for request with ticket number #DOH-276152494243.

Thank you.

Respectfully,
FOI Officer

Dr. Kenneth 09:17 PM, Aug 26, 2020

August 26, 2020

Dear SAMMY JAMESON ASCAN,

Greetings!

Thank you for your request dated Aug 04, 2020 03:37:23 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

Your Request

You asked for TECHNICAL CONCERNS FOR THE REGISTRATION OF DRUG PRODUCTS (3).

Response to Request

Your FOI request is approved. Below are the responses to your inquiries from FDA:

10-11. S4.4 and P4.4 are included in the ACTD, hence, required to be included in the submission.
12. Yes. The specifications and the results of batch analysis should be correlated to each other.
13-14. It is the applicant's responsibility to provide the proposed shelf-life/re-test period and the storage condition of the drug substance, substantiated by corresponding Stability Data in compliance with the Stability Guidelines.

Your right to request a review

If you are unhappy with this response to your FOI request, you may ask us to carry out an internal review of the response by writing to Undersecretary Lilibeth C. David, Chair of Data Governance Oversight Committee/ DOH Central Appeals and Review Committee, at foi@doh.gov.ph. Your review request should explain why you are dissatisfied with this response, and should be made within 15 calendar days from the date when you received this letter. We will complete the review and tell you the result within 30 calendar days from the date when we receive your review request.

If you are not satisfied with the result of the review, you then have the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011).

Thank you.

Respectfully,
FOI Receiving Officer

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