This presentation will provide an outline of the various OTC guidance documents, where to find them on the TGA website and briefly explain how they should be used to assist in compiling a successful OTC application.

1. Using the new OTC guidance to help compile a successful
application
An Update from the Complementary and Over-the-Counter
Medicines Branch of the TGA
Gaelene Pyke
Principal Evaluator
OTC Medicines Evaluation Section, Complementary and Over-the-Counter Medicines Branch
Medicines Regulation Division, TGA
ARCS Scientific Congress Canberra 2016
10-11 August 2016

2. Overview
Provide an outline of the OTC guidance documents you need to be very familiar
with, where to find them on the TGA website, briefly explain how they should be
used to assist in compiling a successful OTC application:
• Purpose of OTC guidance documents
• Background to new guidance
• Location
• Key aspects for preparing an effective OTC application
• Benefits
Using the new OTC guidance to help compile
a successful application
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3. Purpose of OTC guidance documents
OTC guidance documents assist applicants with the process of applying to either
register a new OTC medicine or make changes to the registration details of a
currently registered OTC medicine
• Explains the process involved in:
- registering a new medicine application
- changing a registered medicine
• Identifying correct application level
• Identification of data/information requirements
• Cover letter
• Format of dossier
Using the new OTC guidance to help compile a successful application 2

4. Background to new guidance
• New business process for OTC medicines commenced in 2013 following
extensive consultation with industry and stakeholders
– Staged implementation over 12 months
• New OTC guidance documents needed to be developed and some existing
guidance documents required updating to:
– Reflect changes to OTC business processes
– Provide greater clarity around data and application requirements
– Improve readability and accessibility
Using the new OTC guidance to help compile a successful application 3

5. Location of
guidance
• ARGOM landing page
Using the new OTC guidance to help compile a successful application 4

6. Key aspects for preparing an effective OTC
application
• For ‘new’ medicines, verify proposed medicine is an OTC
• Identify application level
• Identify required supporting data and information
• Cover letter
• CTD format
• Screening
Using the new OTC guidance to help compile a successful application 5

7. Key aspects: processes for new and change
applications
• Understanding the processes
– use the step-by-step guides
Using the new OTC guidance to help compile a successful application 6

8. Key aspects: processes for new and change
applications
New registration applications
• steps in the OTC registration
process for new medicine
applications
Using the new OTC guidance to help compile a successful application 7

9. Key aspects: processes for new and change
applications
Change applications
• steps in the process to change
a registered OTC medicine
Using the new OTC guidance to help compile a successful application 8

10. Key aspects: identify application level
• Determining your application
level
• Appropriate change codes for
change applications
Using the new OTC guidance to help compile a successful application 9

11. Key aspects: identify application level
• Appropriate change codes for
change applications
Using the new OTC guidance to help compile a successful application 10

12. Key aspects: identify required supporting data
and information
• Mandatory requirements for an effective
application
• CTD Module 1: OTC medicines
• Specific technical guidance for OTC
medicines
• Assurances for N1 applications
• N2 application requirements
• General TGA medicines guidance
• EU and ICH guidance
Using the new OTC guidance to help compile a successful application 11

13. Key aspects: identify required supporting data
and information
ARGOM landing page
- ‘Supporting information’
Using the new OTC guidance to help compile a successful application 12

14. Key aspects: identify required supporting data
and information
ARGOM landing page
- ‘Supporting information’
Using the new OTC guidance to help compile a successful application 13

15. Key aspects: cover letter
• Cover letter:
– Nature and scope of application
– Details to be included
– Include in Module 1.0.1
• Assists with screening process
Using the new OTC guidance to help compile a successful application 14

16. Key aspects: format
• Must be in CTD format
Refer to
– General dossier requirements
– Common Technical
Documentation (CTD)
Using the new OTC guidance to help compile a successful application 15

17. Key aspects: screening
• Applications are screened by TGA to ensure:
– Is for an OTC medicine
– Correct application level
– Submitted in correct format
– Mandatory requirements have been met
– Cover letter accurately describes nature and purpose of application
Using the new OTC guidance to help compile a successful application 16

18. Key aspects: screening
• Applications will not be accepted for
evaluation if Mandatory requirements
are not met
• Use of OTC guidance documents will
minimise the chances of an application
not being accepted
Using the new OTC guidance to help compile a successful application 17

19. Benefits
• Provide greater clarity and understanding of application and data requirements
• Improved readability and accessibility
Careful use of new and revised OTC guidance documents by applicants
• Significant improvements in the quality of applications
submitted to the TGA
• Potential to reduce evaluation timeframe
• Increases likelihood of applications being successful
Using the new OTC guidance to help compile a successful application 18

20. Summary
• Be familiar with the OTC guidance documents and Mandatory requirements for an
effective application
• Follow them carefully
• Check application against guidelines when compiling and prior to submitting
• Applications that are consistent with guidelines are more likely to have shorter
evaluation times and be successful
Using the new OTC guidance to help compile a successful application 19