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) Non-prescription medicine application screening – OTC medicines 2
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 Non-prescription medicine application screening – OTC medicines 3
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 4
Australian regulatory guidelines for OTC medicines (ARGOM) landing page Has links to the documents specifying dossier requirements 5
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 6
Mandatory requirements for an effective over-the-counter medicines application 7
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 8
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 Sponsor requested to address minor deficiencies questions (within 5 working days) Non-prescription medicine application screening – OTC medicines 10
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 Non-prescription medicine application screening – OTC medicines 13
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 Non-prescription medicine application screening – OTC medicines 14
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 Non-prescri ption medicine application screening – OTC medicines 15
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 Non-prescription medicine application screening – OTC medicines 16
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 Non-prescription medicine application screening – OTC medicines 17
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) 18 Non-prescription medicine application screening – OTC medicines
Cover letter – change applications • Consider including a table as follows: Change Application Current details Proposed details Reasons for code level change/comments • If relevant, include in your cover letter, reference to: – previous same/similar approvals – related concurrent, ongoing or soon to be submitted applications Non-prescription medicine application screening – OTC medicines 19
20
Recommend
More recommend
