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TGA presentation: Generic and Biosimilar Medicines Association (GBMA) meeting, 2 November 2018

Presentation: The ACSS Consortium and the Generic Medicines Work-Sharing Trial

9 November 2018


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  • Presented by: Christopher Crane, Principle Evaluator, Pharmaceutical Chemistry Section, Scientific Evaluation Branch
  • Presented at: GMBA meeting entitled 'Regulatory Collaboration and Emerging Issues in Generic Medicines'. Held at the Hotel Kurrajong. 8 National Circuit, Barton, Canberra, ACT 2600
  • Presentation date: Friday, 2 November 2018
  • Presentation summary: Short presentation on the ACSS Consortium, the Generic Medicines Working Group and the Generic Medicines Work-Sharing Trial (GMWST - "Jim West").


The ACSS Consortium and the Generic Medicines Work-Sharing Trial

Christopher Crane
Pharmaceutical Chemistry Section
Scientific Evaluation Branch, TGA

2 November 2018

Slide 1 - Introduction

  • What is the ACSS Consortium
  • GMWST Scope and Times
  • Our First Submission
  • Conclusions and the Future

Slide 2 - What is the ACSS Consortium

  • The ACSS Consortium was formed in 2007 by four regulatory authorities: Therapeutic Goods Administration, Health Canada, Singapore's Health Sciences Authority (HSA) and Swissmedic of Switzerland
  • 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)

Slide 3 - GMWST scope and times

  • Limited to simple dosage forms (solutions and immediate release solid orals)
  • Application to 3 of 4 countries with a Reference Regulatory Agency (RRA) and Concerned Regulatory Agencies (CRAs) similar to EU Decentralised Procedure
  • Completion targeted to 5 months after acceptance to encourage applications

Submission filed → 10 days → Submission accepted → 55 days → List of Questions (LOQ) sent to applicant → 30 days → Responses received → 45 days → 2nd round assessment → 20 days → National steps

Slide 4 - Our first submission

  • Major obstacle was the difference in pre-acceptance procedures
  • Needed much pre-submission communication
  • Identified differences in the dataset and the requirements
  • Ensured complete dataset at submission

Slide 5 - 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

Slide 6 - Our first submission

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

Slide 7 - 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

Slide 8 - 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

Submission of Application → 10 days → Acceptance of Application → 65 days → Assessment of Application and issuance of the List of Questions (LOQ) → 30-6- days → Submission of Responses to the LOQ by the Applicant → 45 days → Assessment of Responses and issuance of additional LOQ (if applicable) or recommendation for clearance → 15 days → Submission of Responses to additional LOQ by Applicant (if applicable) → 20 days → Assessment of Responses of additional LOQ (if applicable) → Perform National steps towards decision

Slide 9 - Interested?

Slide 10 - "If you want to go fast go alone. If you want to go far go together" African Proverb

Slide 11 - END SLIDE

Slide 12 - Excerpt from EOI

Summary of Bioequivalence Studies Differences
Information in application to be filed with the proposed RRA (please specify TGA, HC, SMC or HSA): Information to be filed with the CRA (please specify TGA, HC, SMC or HSA): Information in application to be filed eith the CRA (please specify TGA, HC, SMC or HSA): Information in application to be filed with the CRA (please specify TGA, HC, SMC or HSA): Brief discussion of noted differences
Synopsis of Biostudy(ies)
Reference Product Used
Indications approved for the reference product
Approved strengths of reference product

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