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The ACSS Consortium And The Generic Medicines Work-Sharing Trial Christopher Crane Pharmaceutical Chemistry Section Scientific Evaluation Branch, TGA 2 November 2018 Introduction What is the ACSS Consortium GMWST Scope and Times


  1. The ACSS Consortium And The Generic Medicines Work-Sharing Trial Christopher Crane Pharmaceutical Chemistry Section Scientific Evaluation Branch, TGA 2 November 2018

  2. Introduction • What is the ACSS Consortium • GMWST Scope and Times • Our First Submission • Conclusions and the Future 1 ACSS and GMWST

  3. What is the ACSS Consortium • The ACSS Consortium was formed in 2007 by four regulatory authorities • The governance is lead by the Heads of Agencies • Active Working Groups  New Chemical Entities  Biosimilars  Information Technology  Generic Medicines  Complementary Health Products (previously called Complementary Herbal Products) 2

  4. GMWST scope and times • Limited to simple dosage forms (solutions and immediate release solid orals) List of Submission Submission Questions 10 55 filed days accepted days (LOQ) sent to • Application to 3 of 4 countries with a applicant Reference Regulatory Agency (RRA) 30 and Concerned Regulatory Agencies Days (CRAs) similar to EU Decentralised Procedure 2 nd round Responses 20 45 National steps days assessment days received • Completion targeted to 5 months after acceptance to encourage applications 3 ACSS and GMWST

  5. Our First Submission • Major obstacle was the difference in pre-acceptance procedures • Needed much presubmission communication • Identified differences in the dataset and the requirements • Ensured complete dataset at submission 4 ACSS and GMWST

  6. Our First Submission • Application filed and accepted in Australia, Canada and Switzerland in July 2016 – Modules 2-5 of the data sets the same – Module 1 was different in the three countries. – It included 2 single dose BE studies:  3 way crossover proposed vs EU Reference vs EU Reference fasted  2 way crossover proposed vs EU Reference fed – For Australia Module 1 included a justification for the Overseas Reference. – There were also 2 ASMFs • Submission was more complicated than expected 5 ACSS and GMWST

  7. Our First Submission • The TGA was the RRA with HC and • Application was approved in Switzerland Swissmedic as CRAs in late March, in Australia in early April and approval has been recommended in – The questions from all three Canada agencies were put to the Applicant on time – Time to the first decision in all ~9 months – Time for response was extended • The time taken compared to the target – Second round of questions timeframes was: needed – About the same in Australia – 4.5 months quicker in Canada – 7.5 months quicker in Switzerland 6 ACSS and GMWST

  8. Conclusions and the Future • Presubmission communications were important • First Submission was more complicated than expected – Extra time required by Applicant to respond to the Round 1 Qs – Evaluation took an extra round – The Agencies were able to cope with this • Overall timeframe was 9 months rather than the target 5 months. – Saving Applicant and Governments money • Pros and cons for Applicant – Submit to the Agencies concerned at the same time – Answer a single list of questions at a known time 7 ACSS and GMWST

  9. Conclusions and the Future • Widen future scope – from only immediate release oral solid and solution dosage forms – to any possible generic products. • Allow submission to only 2 of the 4 agencies • The timeframes will be amended to give an time from acceptance to decision of 6½ / 7½ months Assessment of Submission of Submission of Application and 30-60 Acceptance of Responses to the LOQ Application days issuance of the List of Application by the Applicant Questions (LOQ) 45 days Assessment of Submission of Assessment of Responses Perform National steps Responses of Responses to and issuance of additional 20 15 towards decision additional LOQ (if days additional LOQ by days LOQ (if applicable) or applicable) Applicant (if applicable) recommendation for clearance 8

  10. Interested? • Expression of Interest Form, Questions and Answers and Operational Procedures documents and can be obtained by emailing tga.international@tga.gov.au • or • Visit the website https://www.tga.gov.au/acss-generic-medicine-work-sharing- trial 9 ACSS and GMWST

  11. 10 ACSS and GMWST

  12. Excerpt from EOI ACSS and GMWST 12

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