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TECHNICAL CONCERNS FOR THE REGISTRATION OF DRUG PRODUCTS (2)

Requested from DOH by SAMMY JAMESON ASCAN at 03:36 PM on Aug 04, 2020.
Purpose: DRUG PRODUCT REGISTRATION
Date of Coverage: 01/01/2020 - 08/04/2020
Tracking no: #DOH-348686862791

SAMMY JAMESON 03:36 PM, Aug 04, 2020

6.	What are Critical Steps and Intermediates? Can that be discussed in general as In-Process Quality Control in the dossier? 
7.	Agency Representation Agreement doesn’t have validity date. What is the validity if it is open-ended?
8.	Is FDA’s Citizen’s charter already functional?
9.	Confirm if the List of Requirements for the registration of generic prescription drug product, under download is still acceptable?
10.	S4.4 is absent in the check-list but present in citizen’s charter, which one should be followed?

FOI 04:31 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 (2).

We received your request on Aug 04, 2020 and will respond on or before Aug 25, 2020 03:36:14 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/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0zNDg2ODY4NjI3OTEM, for request with ticket number #DOH-348686862791.

Thank you.

Respectfully,

FOI Receiving Officer

Dr. Kenneth 02:17 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 09:11 PM, Aug 26, 2020

August 26, 2020

Dear SAMMY JAMESON ASCAN,

I refer to my letter of Aug 04, 2020 03:36:14 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 (2).

Our response to your request is due on Aug 25, 2020 03:36:14 PM. Unfortunately, it is taking longer than expected to deal with your request because we have awaited the response from FDA on this 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 03:36:14 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/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0zNDg2ODY4NjI3OTEM, for request with ticket number #DOH-348686862791.

Thank you.

Respectfully,
FOI Officer

Dr. Kenneth 09:12 PM, Aug 26, 2020

August 26, 2020

Dear SAMMY JAMESON ASCAN,

Greetings!

Thank you for your request dated Aug 04, 2020 03:36:14 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 (2).

Response to Request

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

6. Usually, in the critical steps of the manufacture of the drug substance and/or drug product, IPQC testing is being conducted depending on the type of product and its dosage form. For further details, refer to the ASEAN Guidelines on Manufacturing Process Validation.

7. Unless a specific duration or validity is mentioned in a specific document, including agreements and CPP, the validity shall be until 1 year after the date of issuance of the said document/s.

8. Yes. In addition, discussions are being made for its revision in compliance with RA11032.  

9. The checklist of requirements is posted on the FDA website. However, the applicant should provide the full dossier at once upon submission following the current guidelines. 

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.

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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