Overcoming the stress of non-prescription medicine application - - PowerPoint PPT Presentation

Overcoming the stress of non-prescription medicine application screening

Over-the-counter (OTC) medicines

Dr Sven Johanson Senior Evaluator OTC Medicines Evaluation Section, Complementary & OTC Medicines Branch, TGA ARCS Annual Conference 21 August 2018

Overview

• Why do we screen applications?
• Legislative requirements for passing screening
• Information and formatting requirements
• Mandatory requirements for an effective over-the-counter medicines

application

• Outcomes of screening and screening questions
• Examples of deficiencies resulting in not-effective (‘refused’)

applications

• Change applications and cover letters

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Application screening (‘preliminary assessment’)

Why do we screen applications?

• To ensure that they are ready for evaluation

Screened to ensure that they are: ‒ At the correct application level ‒ Accompanied by correct / complete data set ‒ Correctly formatted (CTD format)

• Legislative requirement (s.23B(1) of the Therapeutic Goods Act)

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Legislative requirements for passing screening

Section 23B of the Therapeutic Goods Act sets out requirements for passing ‘preliminary assessment’ (screening).

• These include:

‒ must be on correct application form ‒ must be accompanied by specific information in a specific format ‒ For ‘restricted medicines’, must include product information in the approved form ‒ Application fee must be paid

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Information and formatting requirements

• Applications must be consistent with the following documents:

‒ Common Technical Document Module 1: OTC medicines

‒ Mandatory requirements for an effective over-the-counter medicines application ‒ General dossier requirements ‒ Relevant guidelines applicable to OTC medicines, as cited in the above documents

• For ‘restricted medicines’, must include product information in the

approved form

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Australian regulatory guidelines for OTC medicines (ARGOM) landing page

Has links to the documents specifying dossier requirements

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Mandatory requirements for an effective over-the-counter medicines application

Comprises:

• Mandatory requirements
• Appendix A - Specific technical data requirements

‒ Details the mandatory requirements with respect to the different application levels / properties ‒ Set out in CTD format

Non-pr

escription medicine application screening – OTC medicines

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Mandatory requirements for an effective over-the-counter medicines application

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Mandatory requirements for an effective over-the-counter medicines application

Appendix A - Module 5

• 3 separate tables covering:

– General application requirements – N4 application requirements – N5 and C4 application requirements

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Mandatory requirements for an effective over-the-counter medicines application

Outcomes of screening



Passes

Advised of acceptance for evaluation



Refused

Notice given that has not passed preliminary assessment

?

Screening questions

Sponsor requested to address minor deficiencies (within 5 working days)

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Screening questions

• Opportunity to make minor corrections

– 5 working days permitted for response

• Examples of typical screening questions / issues:

– Request for letter of authorisation from another sponsor to access data on file – Request for confirmation that stability data were generated using test methods as described and validated in sub-module 3.2.P.5 – Request for any other documentation accidently omitted – Clarification of the nature / scope of the application – General administrative / housekeeping issues (e.g. GMP clearance expiry)

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Examples of deficiencies resulting in refused applications

Bioequivalence / therapeutic equivalence data

 Absence of data demonstrating bioequivalence with the ‘originator’ product (when

required)

 Inadequate justification for not providing a bioequivalence study report

– Justifications need to address all points as specified in both:

• Guidance 15: Biopharmaceutical studies
• Appendix III of the European Union (EU) Guideline on the investigation of

bioequivalence

 Use of a foreign reference product in therapeutic equivalence or BE studies, rather than

the Australian ‘originator’ product ‒ For use of a foreign reference product in BE study, you must demonstrate that it is identical to the Australian reference (Guidance 15: Biopharmaceutical studies).

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Examples of deficiencies resulting in refused applications (cont)

Non-generics submitted as generics

 Proposed ’generic’ is not eligible for consideration because the originator

medicine has not been fully evaluated. Application should be submitted at N5 level with appropriate data – ARGOM requires ‘originator’ medicine to have been approved for marketing in Australia on the basis of a full dossier

 Proposed generic is actually novel quantitative combination of active

• ingredients. Application should be submitted at the N5 level with appropriate

data

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Examples of deficiencies resulting in refused applications (cont)

 Absence of other clinical / efficacy data – e.g. for antiseptic products or in

relation to ‘fast’ claim in product name L

iter ature based submissions (LBS)

 Searches not conducted and/or data not presented in accordance with LBS

requirements; or does not cover all relevant aspects of efficacy or safety – Must be in accordance with TGA guidance Literature based submissions – Requires Module 2

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Examples of deficiencies resulting in refused applications (cont)

Umbrella branding extensions

 Umbrella branding assessment is incomplete or missing

– Refer to Application route for umbrella branded medicines to determine if assessment is required – If required, assessment must address each of the points identified in the ARGOM Appendix 3 guideline 2.2 ‘Umbrella’/family brand names:

• association, differentiation, safety, efficacy, other information

– Requirement for assessment is specified in Common Technical Document Module 1: OTC Medicines under sub-module 1.5.8

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Examples of deficiencies resulting in refused applications (cont)

Module 3 deficiencies

 Antimicrobial preservative efficacy testing (PET) data not provided

– Required for multi-dose liquids and aqueous semi-solid medicines

 Antimicrobial preservative content testing not included in stability studies  Stability data not consistent with other requirements – eg. absence of data under

accelerated storage conditions

 Absence of analytical method validation data

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Change applications

• Screened to ensure correct application level, data, and format.
• Also screened to ensure:

– Appropriate change types selected in the application form – Appropriate changes made to the product details in the application form

• Changes outside the scope of the chosen application level will not be accepted

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Cover letters

Need to be consistent with the guidance Preparing an OTC application cover letter. They should:

• Outline the nature and scope of the application
• Provide a brief rationale for the application level
• Note any justifications being provided for non-compliance with guidelines
• Include request for PBS equivalence statement, if applicable
• Provide relevant background information

– eg. outline any relevant relationships with existing medicines or related applications

• Information regarding fees (reduction/waiver requests)

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Cover letter – change applications

• Consider including a table as follows:
• If relevant, include in your cover letter, reference to:

– previous same/similar approvals – related concurrent, ongoing or soon to be submitted applications Change code Application level Current details Proposed details Reasons for change/comments

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