Reg Domain 5-4: Asynchronous Activity

(Post-Approval Changes)
This asynchronous activity is equivalent to 6 hours of your internship.

blancejeremy@gmail.com Switch account Draft saved

* Indicates required question

Email *

blancejeremy@gmail.com

E-mail Address *

blancejeremy@gmail.com

Student Code *
Format: B15-0000

B15-0245

Last Name *

Bito-onon
First Name *

Lance Jeremy

Name of School *

University of San Agustin

Match the proposed product change to the correct variation classification. *

MiV-
MiV- MiV- MaV- MiV- MiV- MiV- MiV- MaV-
MaV-4 PA2/MaV-
PA24 PA27 15 PA35 PA15 PH03 PA25 PH01
2

Quantitative
change of
excipients
already
registered

t Replacement
of
ngmanufacturing
site of the
drug product

Change of
storage
condition
from
refrigerated
(2-8 oC) to
“not
5 exceeding 25
oC).

Change of
sspecifications
of the drug
- product (non-
compendial)

Addition of
markings to
the tablets

Transfer of
Marketing
n Authorization
Holder

Extension of
shelf-life of
the drug
product from
24 months to
o 36 months

Change of test
stprocedure of
the drug
product

Addition of
subcutaneous
sroute of
administration
onto current
approved
intravenous
route

Change in the
e product label
information to
ocomply with
the
Administrative
veOrder 2016-
0008 “Revised
dRules and
Regulations
Governing the
e Generic
Labeling
Requirements
s of Drug
Products for
Human Use”
Match the proposed change to the correct application fee. *

Equivalent to
P 2,525.00 +
PhP 510.00 PhP 1,010.00 initial
PhP 1,020.00
registration fee

Change of
storage condition
from refrigerated
(2-8 oC) to “not
exceeding 25
oC).

Replacement of
manufacturing
site of the drug
product

Transfer of
Marketing
Authorization
Holder

Change of brand
name (2
proposed brand
names)

Extension of
shelf-life of the
drug product
from 24 months
to 36 months
Match the proposed change to the correct processing timeline. *

120 calendar days 1 working day 120 working days

Change of storage
condition from
refrigerated (2-8 oC)
to “not exceeding 25
oC).

Replacement of
manufacturing site
of the drug product

Transfer of
Marketing
Authorization Holder

Change of brand
name (2 proposed
brand names)

Extension of shelf-
life of the drug
product from 24
months to 36
months

Change/s with minimal/no significant impact on the aspects of quality, safety, *

and efficacy.

"Do and Tell"

Major Variation (notification only)

Major Variation needs prior approval

Minor Variation requiring Prior Approval

The following are changes leading to a new product registration: *

A. Inclusion of an excipient to replace another excipient of the same function

B. Removal of one API from a multicomponent product

C. Change in strength of one or more API/s

D. Increase or addition in/of overage to the inactive excipient/s

A, C, D

B, C

All except D

This Philippine-specific regulation formally adopts the ASEAN Variation *

Guidelines and application requirements and procedures:

ASEAN Variation Guidelines for Pharmaceutical Drug for Human Use

Administrative Order 2018-0021

FDA Circular 2019-006

FDA Circular 2014-008

CASE - 20 points (Answer the questions in the succeeding items): You received an
information from your global regulatory office that the manufacture of the product
Telmisamtin 40 mg Tablet product, which is currently registered in the Philippines
and other APAC affiliates, is planned for a minor change in mixing times and
operating speeds outside of application/validation ranges. As a regulatory affairs
officer, the first thing you did was check and review the Scale-Up Post-Approval
Changes for Immediate Release Oral Solid dosage forms document of the US FDA.
Review of the document, together with ASEAN Variation Guidelines (R1) gave you
the idea of the the correct classification number of the variation/change. The
change can be implemented as soon as all the regional affiliate countries receive a
go signal from the respective affiliate country’s drug regulatory authority in the
form of change approval. As the representative of Philippines affiliate office,
relevant Philippine-specific regulatory information will be required of you to share
to the regional manager. [This is just the case scenario information. Refer to
succeeding items for questions.]

Your answer

In connection to the scenario, what is the change (variation classification) that *

you should apply for? [5 points]

MiV-PA16

MiV-PH03

MiV-PA20

MaV-4
 In connection to the scenario, choose five (5) technical requirements for the *
application for the change. [10 points]

Comparative Dissolution Profile Data

Justification for not submitting a new Bioequivalence Study

Description and summary of the analytical validation

Detailed drawing or written description of the approved and proposed imprint

Copy of approved and proposed release and shelf-life specifications

Certificate of Analysis and/or Batch Analysis

Description of the proposed manufacturing process and technical justification for

the change

According to the FDA Citizen's Charter, how long should it take for the FDA to *
process the application? What is the timeline for the change in the scenario? [5
points]

52 working days

254 calendar days

120 calendar days

120 working days

254 working days

A copy of your responses will be emailed to the address you provided.

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