You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Presentation: Using the new OTC guidance to help compile a successful application

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

15 August 2016

Disclaimer

These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Gaelene Pyke
  • Presented at: ARCS Scientific Congress
  • Presentation date: 10-11 August 2016
  • Presentation summary: 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.

Transcript

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

Slide 1 - 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

Slide 2 - 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

Slide 3 - 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

Slide 4 - Location of guidance

  • ARGOM landing page

argom

Slide 5 - 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

Slide 6 - Key aspects: processes for new and change applications

  • Understanding the processes
    • use the step-by-step guides

process

Slide 7 - Key aspects: processes for new and change applications

New registration applications

  • steps in the OTC registration process for new medicine applications

steps

Slide 8 - Key aspects: processes for new and change applications

Change applications

  • steps in the process to change a registered OTC medicine

steps

Slide 9 - Key aspects: identify application level

  • Determining your application level
  • Appropriate change codes for change applications

levels

Slide 10 - Key aspects: identify application level

  • Appropriate change codes for change applications

basics

Slide 11 - 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

application

Slide 12 - Key aspects: identify required supporting data and information

ARGOM landing page - 'Supporting information'

application

Slide 13 - Key aspects: identify required supporting data and information

ARGOM landing page - 'Supporting information'

application

Slide 14 - 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

application

Slide 15 - Key aspects: format

  • Must be in CTD format
  • Refer to
    • General dossier requirements
    • Common Technical Documentation (CTD)

application

Slide 16 - 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

Slide 17 - 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

application

Slide 18 - 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

Slide 19 - 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

Print version

How to access a pdf document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.