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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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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • 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").

Transcript

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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