This session will provide an overview of the pre-market prescription medicines process and information needed for an effective submission.

1. Session A03: Hints and Tips for Acceptance of your
Prescription Medicines Submission(s)
Melissa Quinn B.Pharm (Hons)
Director & Senior Pharmacist - Application Management & Exports Section
Prescription Medicines Authorisation Branch
Medicines Regulation Division
Therapeutic Goods Administration
ARCS
21 August 2018

2. Outline
• Prescription Medicines: Regulation Basics
• General Workflow for Screening Applications
• The Registration Process
• Legislative Basis for Applications
• Application Categories
• How to Submit Applications
• Pre- application Activities
• Focus on Category 1 Applications
• Application Acceptance
• Mandatory Requirements – Overview
• Fees and Charges
• So…What Goes Wrong?
• How We Can Help
• What is TGA Currently Working On?
• Final Hints and Tips
• Questions?
1

3. Some Stakeholder Management
Things this presenter is not: An IT or legal expert!
– When you encounter issues with forms or IT systems, please always give feedback so we can resolve as
quickly as possible.
– Resolutions for existing IT problems will not be provided in this talk but I am happy to take a list of
questions on notice!
– Many legislation related queries are very situation specific and the TGA generally cannot provide external
stakeholders with legal advice, but can provide some direction/guidance when appropriate.
– It is important for you to understand the relevant legislation and seek your own legal advice as required.
2

4. Prescription Medicines: Regulation Basics
3

5. Prescription Medicines Registration
Pharmaceutical Benefits Division
Product Billing
& Industry
Assistance
Section
Regulatory Practice &
Support Division
Scheduling &
Committee
Support
Section
Medicines Regulation
Division
Medical Devices &
Product Quality Division
PM
Registration
Processes
Prescription
Medicines
Authorisation
Branch
Scientific
Evaluation Branch
Pharmacovigilance
and Special Access
Branch
Laboratories
Branch
Manufacturing
Quality Branch

6. Prescription Medicines Authorisation Branch Structure
• The Prescription Medicines Authorisation Branch is comprised of 6 Clinical Evaluation Units (CEU).
• Each unit is responsible for assessing prescription medicines applications within particular therapeutic areas.
CEU 1
• Analgesia
• Neurological disorders
• Psychiatric/Psychological/
Behavioural disorders
• Anaesthesia
• Gastrointestinal disorders
• Nutrition
• Disorders of the mouth
• Disorders of the skin
• Poisoning
o Opioid antagonists
CEU 2
• Infectious diseases
• Vaccination against infectious
disease
• Immunological disorders
• Other
o radiological agents (e.g. contrast
media)
o adjuncts to
radiopharmaceuticals and
contrast media use
o diagnostic tests for infections
o allergens (diagnostic or
therapeutic)
o antivenenes
o radiopharmaceuticals for cancer
(diagnostic)
CEU 3
• Cardiac disorders
• Lipid disorders
• Inherited metabolic
disorders
• Vascular disorders
• Musculoskeletal disorders
• Disorders of the male
reproductive system
• Renal & urinary tract
disorders
• Disorders of the ear
• Poisoning
o Heavy metal poisoning
o Cyanide poisoning
CEU 4
• Neoplastic disorders
o solid tumour oncology
o hormonal effects of
functioning carcinoid
neoplasms
o Radiopharmaceuticals for
solid tumours (therapeutic)
CEU 5
• Contraception
• Infertility
• Obesity
• Paget’s disease of bone
• Endocrine disorders
• Disorders of the female
reproductive system
• Pregnancy and labour
• Fluid & electrolyte
disorders
• Disorders of the eye
• Respiratory disorders
• Disorders of the nose,
paranasal sinuses &
upper airway
CEU 6
• Haematological
disorders, including
haematological
malignancies
o radiopharmaceuticals for
cancer (therapeutic)
• Other
o Surgical haemostasis
(plasma products)
Further information can be found in Guidance 4 of the Australian Guidelines for Prescription Medicines (ARGPM)

7. Branch Overview: Sections
Application Entry Team
Application Support Team
Exports
FOI requests
Retrospective performance
reporting
KPI reporting
Sponsor Pipeline Reporting
(Forecasting)
Business improvements and
solutions
eCTD reform
B2B Portal Premier Replacement
External evaluator procurement
Reforms implementation
Associated legislative and
guidance change
Change management
AusPAR preparation and
publication
Business Systems Review &
Reporting
aet.application.entry.team@health.gov.au
ast.application.support.team@health.gov.au
Application Entry, Support &
Exports
Transparency Reforms &
Evaluation Support
Application & Advisory
Management
Case Management
Media and ministerial
enquiries
Secretary of Advisory
Committee for Medicines
International work-sharing
Streamlined Submission
Review
Pre-submission meetings
streamlinedsubmission@health.gov.au

8. General workflow for screening applications
Application received and application fees paid
Date = 40 working day start
Application screened by AESE (administrative) and assigned to a
case manager for further technical screening
Application has minor
deficiencies
Opportunity to remedy minor
deficiencies
Deficiencies
unresolved
Application has
critical issues/
unresolved deficiencies
Notice of refusal sent
Deficiencies
resolved
Application
acceptable
Notice of acceptance sent
Payment of evaluation feesCMES
7

9. Evaluation: Key Phases
Phase Description
1. Pre-submission Applicant provides necessary information on scope and scale of application. Assists
resource planning
2. Submission TGA completes activities in preparation for application evaluation. Letter of application
acceptance. NOTE: Application MUST be in the Form approved by the Secretary.
3. First round assessment Evaluators assess the dossier
4 Consolidated Section 31 requests TGA will consolidate all questions from evaluators and send to applicant. Stop Clock.
Rolling questions used for Priority
5. Second round assessment TGA evaluators assess the application in view of the response to questions
6. Expert advisory review Delegate may seek independent advice after considering all evaluation reports
7 TGA Decision TGA delegate makes a decision
8. Post-decision Administrative and regulatory activities are completed
8

10. • Multiple submission pathways ranging from 120-220 target days to provide efficiencies in market approvals
 Priority Review (Jul 2017) = substantial evidence & complete data dossier
 Provisional Approval (Mar 2018) = early clinical safety & efficacy data
 Comparable Overseas Regulator (COR) report-based process (Jan 2018)
9

11. 10

12. The Registration Process
A submission to register a new prescription medicine is supported by:
1. Quality data: for both the drug substances (drug master files etc.) and for the dosage form
2. Nonclinical data (if required)
3. Clinical data: might be evidence of bioavailability
(i.e. the extent and rate of release from the dosage form:
in vivo or sometime in vitro)
4. Evidence of Good Manufacturing Practice is required.
Data required outlined in the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
11

13. Applications
• Set out in the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990.
– Section 9C – request for copy of ARTG entry
– Section 9D – request to vary information about an ARTG entry
– Section 14 – exemption from compliance with a standard
– Section 23 – registration or listing (in this case each application results in a single registration or listing
or inclusion of a separate and distinct product within a grouped registration or listing)
– Section 61 (6) – request for information from ARTG
– Regulation 14 – transfer of goods registered/listed
– Regulation 14A – reassignment of registration/listing numbers
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14. Application Categories
• Regulations 16A to 16G, includes statutory processing times.
• Category 1 applications:
– An application for a new medicine or a change to a medicine constitutes a Category 1 application if it
does not meet the requirements of Category 3
• Comparable Overseas Regulator (COR) report based process:
– Implemented on 2 Jan 2018 as part of MMDR reforms
– Builds on previous Category 2 process.
• Category 3 applications:
– Changes to quality data of a medicine already in the ARTG
13

15. How to Submit Applications
• Obtain access to TGA Business Services www.tga.gov.au/tga-business-services.
– Prescription medicines applications are lodged via the TBS portal.
– Applicants need to be set up in the TGA client database in order to lodge applications.
• Applicants should ensure their company generic email address has been added to the TGA client
database.
14

16. Pre- application Activities
• Approved terminology for medicines (ingredient names)
– Look at how to propose a new ingredient name https://www.tga.gov.au/proposing-new-ingredient-
name
• Pre-submission meetings
– Look at requirements outlined in pre-submission planning form
www.tga.gov.au/form/pre-submission-planning-form-ppf
• Other considerations
– Product Information: New format as of 2 January 2018
– Consumer Medicine Information (CMI)
– Patent certification and data exclusivity
15

17. Category 1 Applications
New chemical/biological entity or biosimilar medicine OR
Change(s) to an existing good that MAY create a separate and distinct good on the ARTG
• Applies to:
– applications for new dosage forms
– new fixed–dose combinations
– new strengths and new generic products
– extensions of indications
– amendments to the Product Information (type J, otherwise 9D)
– Additional trade names (45 working days, no longer Cat 1)
– Changes to product information
16

18. Category 1 Applications
• Major variation, for therapeutic goods of a particular kind, means a change to:
a) the strength, as recorded in the entry in the Register; or
b) the dosage, the recommended dose regimen or the maximum daily dose; or
c) the dosage form; or
d) the route of administration; or
e) the intended patient group
f) some types of minor variations (type G and H)
Requires evaluation of clinical, pre-clinical and/or bioequivalence data.
17

19. Comparative Overseas Regulator (COR) (previously known as Category 2)
• Implemented on 2 January 2018
• Must be from a country/jurisdiction determined to be ‘comparable’
COUNTRY OR JURISDICTION REGULATORY AUTHORITY
Countries
Canada Health Canada
Singapore Health Science Authority Singapore (HSA)
Switzerland SwissMedic
United Kingdom
Medicines and Healthcare products
Regulatory Agency (MHRA)
United States Food and Drug Administration (FDA)
Jurisdictions
European Union
European Medicines Agency (EMA) -
centralised and decentralised processes
18

20. Comparative Overseas Regulator (COR)
Open to applications where the medicine has received full overseas marketing approval following a de novo
evaluation.
COR approach A (target time frame of 120 working days)
• identical medicine and manufacturing to that approved by the COR, with evidence of compliance with Good
Manufacturing Practice (GMP)
• the full overseas marketing approval for the medicine is no older than 1 year
• aside from the label, PI and RMP (where required), no additional evaluation of Australian specific data is
required.
COR approach B (target time frame of 175 working days)
• TGA evaluation of certain data, in addition to the label, PI and RMP.
• The amount and type of additional data requiring evaluation will determine whether the application is best
processed under the COR-B approach or as a Category 1 application.
• E.g. stability data, validation data for an additional manufacturing site and updates to pivotal studies that
support the proposed indication.
See: https://www.tga.gov.au/publication/comparable-overseas-regulators-cors-prescription-medicines
19

21. Category 3 Applications
• Minor variation, for therapeutic goods of a particular kind, means a change (other than a change that is
a major variation) to:
a) the formulation, composition or design specification; or
b) the container for the goods;
c) any other attribute of the goods that results in the goods being separate and distinct
• Other minor variations:
– Correction of an ARTG entry that is incomplete or incorrect
– Safety-related requests (SRR), with and without data, Self Assessable Request (SAR)
– Minor editorial Change (MEC), Notifications
More notifiable changes (enhancements) are coming in 2019/2020
20

22. Example: Minor Variations Applications
Launched July 2017
• Log on to the TBS portal
• Select Variation under prescription medicine
21

23. Application Acceptance
• See Mandatory requirements for an effective application for Category 1
• See Minor variations to prescription medicines for minor variations
• Application Entry Team conducts an administrative screen of application
– Checks that application fee is paid
• Once accepted for evaluation
– Notifying letter of acceptability and evaluation fee invoice sent to sponsor
– Statutory evaluation period applies
– Application lapses if evaluation fee is not paid by due date
22

24. Dossier Submission For Registration
• Common Technical document (CTD)
– A set of specifications for a dossier for the registration of medicines.
• General dossier requirements
www.tga.gov.au/publication/general-dossier-requirements
• eCTD specifications
www.tga.gov.au/book-page/ectd-preparation-tools
• Non eCTD electronic submissions
www.tga.gov.au/book/organising-nees-submissions
23

25. Guidance
• Scientific guidelines
• Forms and templates
• Regulatory decisions and notices
for prescription medicines
• www.tga.gov.au/standards-
guidelines-prescription-medicines
24

26. Mandatory Requirements
• Structure and Format
• Content
– Technical data requirements (Appendix A – specific mandatory requirements https://www.tga.gov.au/book-page/appendix-
specific-mandatory-requirements)
– Australian and adopted international guidelines
• Justification of data gaps
• Administrative requirements
Note:
– There are no “secret guidelines” but a section can determine that there are other matters which are relevant to an
application, relevant to best practice and risk-management for use in an Australian population
– Post-market experience may not be specific enough to manage an identified risk with an application.
25

27. Mandatory Requirements – Overview
ITEM REQUIREMENT
Language All information must be in English and readable
Measurements Units of measurement must use the metric system (or other appropriate units, such as those generally accepted in
clinical practice e.g. SI)
Provision of Module 1 All application dossiers must include Module 1.
Electronic Data Must be submitted in either the eCTD or NeeS format*
* note: TGA will likely be moving to eCTD only in the next 2-3 years. Are you ready?
Applications that have previously
been rejected by the TGA or
withdrawn by the applicant
before a decision by the TGA
Delegate.
• Applicants must identify in the letter of application how the deficiencies identified in the previous application have
been addressed.
• To ensure that the data to be evaluated by the TGA are the current data relevant to that application, the applicant
must provide:
• A complete, up-to-date electronic data set for each new application.
• A complete new Module 1 plus replacement for those volumes that have changed, plus any additional
volumes. The letter of application must specify which modules and data volumes from the previous
application should be used for the current application.
• Data previously submitted to us must be clearly identified in the Table of Contents of the dossier.
26

28. Module One
ITEM REQUIREMENT
Cover Letter Must be included in Module 1.0.1 for all regulatory activities (submissions) and for each sequence associated with that regulatory activity.
Lifecycle management tracking table Must be included in Module 1.0.2 for all regulatory activities and for each sequence associated with that regulatory activity provided in
the eCTD format.
Table of Contents Must be included for all regulatory activities and for each sequence associated with that regulatory activity provided in the NeeS format
Letter of Authorisation If an applicant is acting on behalf of another applicant, a letter of authorisation must be provided.
Where the applicant is using another company's name and/or livery on labels, a letter of authorisation from the company owning the
name/livery must be provided.
Application Form Must be included in Module 1.2.1 for all applications
Literature-based submission
documents
If your application partially or completely relies on a literature-based data set include either:
• confirm the search strategy used to generate the search output for the application is in full accordance with the search strategy
approved by the TGA; OR
• document and include the reasons for all changes if not in full accordance with the search strategy approved by the TGA.
Information must be included in Module 1.5.1 in these instances.
Designation applications – supporting
documents
To be eligible for the relevant pathway, applicants must provide a copy of the priority or provisional determination letter that was issued
by the TGA. The determination must be in force at the time of making the section 23 application.
To be eligible for a waiver of the section 23 application and evaluation fees, applicants must provide a copy of the Orphan drug
designation letter that was issued by the TGA. The designation must be in force at the time of making the application.
Information must be included in Module 1.5.2 in these instances.
27

29. Module One
ITEM REQUIREMENT
Declaration of compliance with Pre-
submission planning form and
planning letter
• In Module 1.7.3, applicants must provide a declaration of compliance with the information provided about the application(s) in the
PPF (including attachments) and planning letter.
• The declaration must also address any issues that were raised in the planning letter, and identify how the issues were resolved in the
application.
Risk Management plan for Australia Include in all regulatory activities for:
• a new chemical entity
• a new vaccine
• an application for provisional registration
• a generic medicinal product where a safety concern with the reference medicinal product requires additional risk minimisation
activities.
Include an RMP under certain circumstances for other applications as descripted in Risk management plans for medicines and biologicals.
The Risk Management Plan must be the current, unaltered EU-RMP and an Australian Specific Annex should be included. An alternative
to the EU RMP is acceptable only if there is no current EU-RMP.
Include in Module 1.8.2.
Justification for not providing
appropriate biopharmaceutic studies
A justification within Module 1.11.2 is required when:
• biopharmaceutic data provided have been generated against an overseas reference product.
• a BCS (Biopharmaceutics Classification System)-based biowaiver approach is used.
• biopharmaceutic data do not cover all the different strengths for a new medicine.
• where biopharmaceutic data are required but have not been provided for one or more products.
Such a justification must consist of a document that:
• provides an accurate, robust and scientific response to each point/heading listed in Biopharmaceutic studies - Justification for not
submitting biopharmaceutic data
• provides any other information relevant to the justification in separate section/s, and
• addresses any other aspects from relevant EU guidelines adopted in Australia (for example, Guideline on the investigation of
bioequivalence CPMP/QWP/EWP/1401/98 Rev 1). 28

30. Dossier Documents – Matrix Modules: Module Two (Category 1/COR)
Category 1/category 2 applications - Module 2
TGA's application fee type is … A - NCE B - New
Combination
C – Extension of
indication
D – New generic
medicineApplying for a … New chemical entity New salt or ester of
existing active
ingredient
Similar biological
medicinal product
Module 2.1 Table of contents Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory
Module 2.2 Introduction Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory
Module 2.3 Quality overall
summary
Mandatory Mandatory Mandatory Mandatory Not required Mandatory
Module 2.4 Nonclinical
overview
Mandatory Mandatory Mandatory Mandatory May be required* May be required*
Module 2.5 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory
Module 2.6 Nonclinical
overview
Mandatory Mandatory Mandatory May be required* May be required* May be required*
Module 2.7 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory May be required*
*Refer to Module 1 requirements.
https://www.tga.gov.au/dossier-documents-matrix-module-2-5
29

31. Dossier Documents – Matrix Modules: Module Two (Category 1/COR)
Category 1/category 2 applications - Module 2
TGA's application fee type is … F - Major variation E - Additional
tradename
J - PI Change
requiring
evaluation
Applying for a … New strength New dosage form New route of
administration
Change in patient
group (not
decrease)
Change of dosage
Module 2.1 Table of contents Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be
required.*
Module 2.2 Introduction Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be
required.*
Module 2.3 Quality overall
summary
Mandatory Mandatory May be
required.*
Not required Not required Not required May be
required.*
Module 2.4 Nonclinical
overview
May be
required.*
May be
required.*
May be
required.*
May be
required.*
May be
required.*
Not required May be
required.*
Module 2.5 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be
required.*
Module 2.6 Nonclinical
overview
May be
required.*
May be
required.*
May be
required.*
May be
required.*
May be
required.*
Not required May be
required.*
Module 2.7 Clinical overview May be
required.*
Mandatory Mandatory Mandatory Mandatory Not required May be
required.*
*Refer to Module 1 requirements.
https://www.tga.gov.au/dossier-documents-matrix-module-2-5 30

32. Dossier Documents – Matrix Modules: Module Two (Category 3)
TGA's application fee type is … G - Minor variation, new Register entry H - Minor variation, not
resulting in a new
Register Entry
Applying for a … Change of formulation New container type Change of tradename
Module 2.1 Table of contents May be required* May be required* Not required May be required*
Module 2.2 Introduction May be required* May be required* Not required May be required*
Module 2.3 Quality overall
summary
Mandatory Mandatory Not required Mandatory
Module 2.4 Nonclinical overview Not required Not required Not required Not required
Module 2.5 Clinical overview Not required Not required Not required Not required
Module 2.6 Nonclinical overview Not required Not required Not required Not required
Module 2.7 Clinical overview Not required Not required Not required Not required
*Refer to Module 1 requirements.
https://www.tga.gov.au/dossier-documents-matrix-module-2-5
31

33. Dossier Documents – Matrix Modules: Modules 3-5 (Category 1/COR)
Category 1/category 2 applications - other modules
TGA's application fee
type is …
A - NCE B - New Combination C – Extension of
indication
D – New generic
medicine
Applying for a … New chemical entity New salt or ester of
existing active
ingredient
Similar biological
medicinal product
Module 3—Quality Mandatory Mandatory Mandatory Mandatory Not required Mandatory
Module 4—Nonclinical Mandatory Mandatory Mandatory May be required* May be required* May be required*
Module 5—Clinical Mandatory Mandatory Mandatory Mandatory Mandatory May be required*
Module 5.3.1 Reports
of biopharmaceutic
studies
May be required* May be required* May be required* May be required* Not required May be required*
Module 5.3.2
Pharmacokinetic
studies using human
biomaterials
May be required* May be required* May be required* May be required* May be required* Not required
*Refer to Module 1 requirements.
https://www.tga.gov.au/dossier-documents-matrix-module-2-5
32

34. Dossier Documents – Matrix Modules: Modules 3-5 (Category 1/COR)
Category 1/category 2 applications - other modules
TGA's application
fee type is …
F - Major variation E - Additional
tradename
J - PI Change
requiring evaluation
Applying for a … New strength New dosage form New route of
administration
Change in patient
group (not decrese)
Change of dosage
Module 3—Quality Mandatory Mandatory May be required* Not required Not required Not required Not required
Module 4—
Nonclinical
May be required* May be required* May be required* May be required* May be required* Not required May be required*
Module 5—Clinical May be required* Mandatory Mandatory Mandatory Mandatory Not required May be required*
Module 5.3.1
Reports of
biopharmaceutic
studies
May be required* May be required* May be required* Not required May be required* Not required May be required*
Module 5.3.2
Pharmacokinetic
studies using
human biomaterials
May be required* May be required* May be required* May be required* May be required* Not required May be required*
*Refer to Module 1 requirements.
https://www.tga.gov.au/dossier-documents-matrix-module-2-5
33

35. Dossier Documents – Matrix Modules: Modules 3-5 (Category 3)
TGA's application fee type is … G - Minor variation, new Register entry H - Minor variation, not resulting
in a new Register EntryApplying for a … Change of formulation New container type Change of tradename
Module 3—Quality Mandatory Mandatory Not required Mandatory
Module 4—Nonclinical Not required Not required Not required Not required
Module 5—Clinical Not required Not required Not required Not required
Module 5.3.1 Reports of
biopharmaceutic studies
Not required Not required Not required Not required
Module 5.3.2 Pharmacokinetic
studies using human
biomaterials
Not required Not required Not required Not required
https://www.tga.gov.au/dossier-documents-matrix-module-2-5
• Application types G and H are shown as Category 3 application. They may be Cat 1/2 or Cat 3 depending on whether they are
supported by clinical, nonclinical or bioavailability data (Cat 1/2) or not (Cat 3).
• Cat 1/2 G and H are not included in the dossier in these table(s).
• If nonclinical (Module 4), clinical (Module 5) or bio-availability (Module 5.3) data are submitted, relevant Module 2 summaries and
overviews will be required.
• Modules 1.8, 1.9 and 1.11 may also be required, depending on the application.
34

36. Fees and Charges
• TGA required to recover all costs through fees and charges for activities within scope of the Act.
– A fee is charged for a service e.g. evaluation of an application
– A charge is a form of tax applied per financial year
• Fees and charges set out in Schedule 9 of the Therapeutic Goods Regulations 1990 and Therapeutic
Goods (Charges) Regulations 1990.
• A full list of the fees and charges that apply to prescription medicines can be found on the TGA website:
www.tga.gov.au/book-page/prescription-medicines-2
• Further enquiries in relation to fees for prescription medicines should be directed to:
AET.application.entry.team@tga.gov.au
35

37. Fees and Charges
• The type of fees set will depend on whether TGA requires to evaluate data and the level of effort
associated with that service
• Application type relates to the fees associated with an application and is identified by a letter (for
example, A, B or C application types).
• Data requirements determine the fees associated.
• Examples include:
– new chemical entity
– new indication or major variation.
36

38. Fees and charges
• Category 1 applications types
A: New chemical or biological entity, biosimilar medicine or New salt/ester of previously approved active
ingredients
B: New combination of previously approved active ingredients
C: Extension of indications
D: New Generic medicines
E: Major Variation – Additional trade name
F: Major variation – New strength, new dosage form, new route of administration, change/increase in
patient group, change in dosage
J: Change to Product information requiring the evaluation of clinical, non clinical or bioequivalence data
37

39. So…What Goes Wrong?
• Incorrect application/submission type
• Missing essential data – gross deficiency or insufficiency (such as an entire module missing)
• Not meeting required guidelines and standards – including lack of justification for missing data
• Nil/expired GMP (when not rectified prior to completion of evaluation process)
• Format of reports
– Summaries/unpublished manuscripts instead of full study reports
– Documents not in English
– Unacceptable dossier format(s)
• Inadequate safety and/or efficacy data – e.g. for the target population, duration of use, indications etc.
• Bioequivalence and biowavers – biowavers not appropriate for the formulation, inadequate justification
• Unclear cover letters with unclear directions to TGA
• Inappropriate bundling of applications/submissions
• Fees not paid on time
• Not fully responding to identified issues identified in screening or s31 requests 38

40. How We Can Help
• Email – your assigned case manager, or AET
• Pre-submission meetings – USE THEM!
• SME Assist hub
39

41. More information on our website
• Australian Regulatory Guidelines for Prescription Medicines
https://www.tga.gov.au/publication/australian-regulatory-guidelines-prescription-medicines-argpm
• Standards & guidelines for prescription medicines
– https://www.tga.gov.au/standards-guidelines-prescription-medicines
– https://www.tga.gov.au/prescription-medicines-registration-process
– https://www.tga.gov.au/publication/common-technical-document-ctd
• Forms for prescription medicine sponsors
https://www.tga.gov.au/forms-prescription-medicine-sponsors
• Regulatory decisions and notices
https://www.tga.gov.au/regulatory-decisions-and-notices-prescription-medicines
40

42. What is TGA Currently Working On?
• Revisions to the mandatory requirements with a clearer distinction between what is mandatory vs what is a
guideline
• Providing better information and a linkage between which mandatory requirement was not met with any
rejection at the entry stage
• A better process for the review and maintenance of EU guidelines that have been adopted (or adopted with
annotations)
• Being more rigorous in ensuring that any Cat 1 application (in particular) meets the form required by the
Secretary (as enshrined in recent legislative amendments)
• A user guide for e-forms to assist external users
• Compiling a list of the most common issues with applications to update/add to the FAQs as well as resolve
any IT related issues being experienced where possible
• Enhancements to the Minor Variations e-form with more variations to become notifiable to the TGA
41

43. Final Hints and Tips:
1. Check if your product is a therapeutic good and what type (e.g. OTC/Prescription)
2. Decide whether you want to have it approved in your name to supply it in Australia
3. Understand the legal requirements for your product to be approved and your legal responsibilities of being a
sponsor
4. Find out what type of therapeutic good the product is and review the relevant guidelines
5. Determine if it meets a particular submission pathway and application type
6. Understand the dossier/submission requirements and ensure you have ALL required data
7. Understand what it will cost you
8. Seek further advice if you need it!
Keep your details up to date with TGA (TBS)
Use the pre-submission planning session
Consider using the SME Assist tools 42

44. Questions?
43