Guidance on bioequivalence Bioavailability, bioequivalence and - - PowerPoint PPT Presentation
Guidance on bioequivalence Bioavailability, bioequivalence and biowaiver data summary forms Wenjie Ji and Dr Christopher Crane Pharmaceutical Chemistry Section Scientific Evaluation Branch Medicines Regulation Division, TGA 4 June 2020
Bioavailability, bioequivalence and biowaiver data summary forms
Wenjie Ji and Dr Christopher Crane Pharmaceutical Chemistry Section Scientific Evaluation Branch Medicines Regulation Division, TGA 4 June 2020
How does it help you How to complete the new forms Recent updates Q&A
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Additional strength biowaiver Biopharmaceutics Classification System (BCS)-based biowaiver The forms are: Non-mandatory New prescription generic medicine submissions Currently, we have received completed templates in submissions
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– Using data summary forms – not new concept e.g. Swissmedic, Health Canada, World Health Organization (WHO) and etc Effects of using these forms Support for sponsors with respect to meeting technical requirements Increased efficiency to the evaluation process
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– – – February 2019 public consultation: Reforms to the generic medicine market authorisation process Reducing barriers through international alignment Increased clarity and transparency of regulatory requirements Supporting work sharing opportunities Need for a robust supply of medicines in Australia
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health professionals, consumer groups, international technical working group and a statutory authority Feedback received: strong support for the reform Specifically for the forms: adopting forms Increase clarity and transparency Increase international alignment Increase opportunity for international collaboration Reduce regulatory burden
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The new forms were developed based on:
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Bioequivalence study information form developed by Australia-Canada- Singapore-Switzerland (ACSS) Consortium Similar to forms used by Swissmedic, Health Canada, WHO Most key technical requirements are the same Biowaiver templates developed by International Pharmaceutical Regulators Programme (IPRP) Similar to forms used by WHO Most key technical requirements are the same
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– – Q&A style format Better clarify what information to provide Consistent style Additional TGA guidance to help complete the forms
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Bioequivalence study form submitted to Canada Singapore Switzerland IPRP biowaiver forms submitted to one of our comparable overseas regulator With the condition that: Your overseas submission has been accepted for evaluation Full details on condition of acceptance is detailed in a guidance prepared for the forms Consequently, you may be using an overseas reference product.
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CTD module 1.9.1 - Summary of a Bioavailability or Bioequivalence Study form CTD module 2.5 CTD module 2.7
Not required for most new generic prescription medicine submissions See full details in guidance
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Applicant specific sections:
Location in the dossier for critical raw data Applicant response to the s31 requests Evaluator specific sections: Evaluator comment s31 requests s31 response assessment Final recommendation on bioequivalence The new form includes applicant’s section and evaluator’s section
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The guidance includes sections on:
– When to use the forms How to include forms for an application Changes to dossier requirements How to include overseas forms How to complete the forms including additional explanatory notes for some section example responses Any issues contact PCS inbox: pcsinbox@health.gov.au
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On 1 April, the following forms were updated following external feedback:
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Bioequivalence Study Information Form (BSIF): Removed request under section 2.2 to include information on ‘Recent inspections of the clinical and bioanalytical sites by Regulatory Authorities’ Guidance updated, where explanatory notes of this part was removed Additional biowaiver form: A minor editorial amendment has been made to the assurances in section 3.5.3
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