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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 Non-prescription medicine application screening – OTC medicines 1
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 Non-prescription medicine application screening – OTC medicines
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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) Non-prescription medicine application screening – OTC medicines 11
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). 12
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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