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TECHNICAL CONCERNS FOR THE REGISTRATION OF DRUG PRODUCTS (4)

Requested from DOH by SAMMY JAMESON ASCAN at 03:38 PM on Aug 04, 2020.
Purpose: DRUG REGISTRATION
Date of Coverage: 01/01/2020 - 08/04/2020
Tracking no: #DOH-412813533847

SAMMY JAMESON 03:38 PM, Aug 04, 2020

15.	Under P6 of ACTD, please clarify which Reference Standard are we going to use? Is it Finished Drug Product or Drug Substance? There are numerous dossiers which make use of drug substances but I want to know which is really the correct reference standard for P6.   Are there any specific guidelines for P6 Reference Standard other than the ACTD?  Is it acceptable to use drug substance, like Telmisartan, USP Reference standard as reference for P6? Please justify.

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 (4).

We received your request on Aug 04, 2020 and will respond on or before Aug 25, 2020 03:38:28 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/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC00MTI4MTM1MzM4NDcM, for request with ticket number #DOH-412813533847.

Thank you.

Respectfully,

FOI Receiving Officer

Dr. Kenneth 02:19 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 09:19 PM, Aug 26, 2020

August 26, 2020

Dear SAMMY JAMESON ASCAN,

I refer to my letter of Aug 04, 2020 03:38:28 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 (4).

Our response to your request is due on Aug 25, 2020 03:38:28 PM. Unfortunately, it is taking longer than expected to deal with your request because we have awaited the response from FDA.

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 03:38:28 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/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC00MTI4MTM1MzM4NDcM, for request with ticket number #DOH-412813533847.

Thank you.

Respectfully,
FOI Officer

Dr. Kenneth 09:20 PM, Aug 26, 2020

August 26, 2020

Dear SAMMY JAMESON ASCAN,

Greetings!

Thank you for your request dated Aug 04, 2020 03:38:28 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 (4).

Response to Request

Your FOI request is approved. Below is the response from FDA on your inquiry:

15.  For reference standards, the manufacturer may use the primary or secondary standard. The Pharmacopoeial convention/company, e.g. USP, BP and Ph. Eur., is responsible for the formulation of the primary standard, while the secondary standard, which is compared with the primary standard, is made by the manufacturer of the drug substance or drug product. In this case, if the reference standard shall be used specifically for the drug product, then the corresponding standard stated in the analytical procedure shall be used. Note that in certain cases, a reference standard is used solely for the analysis of the drug substance or drug product. Hence, for reference standards, the applicant should take into consideration the analytical procedures for the drug substance and drug product, then the reference standard used in certain procedures such as Assay, Identification and Impurity tests.


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,

Dr. Kenneth Ronquillo
FOI Receiving Officer

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