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Update on regulatory reforms from the Scientific Evaluation Branch
The document provides an update on regulatory reforms by the TGA, focusing on variations to registered medicines, generic medicines reform, and new regulations for human cells and tissues. It outlines enhancements to the electronic application process, new bioequivalence templates, and changes to the regulatory framework for faecal microbiota transplantation. The document emphasizes ongoing consultation efforts and the importance of aligning Australian regulations with international standards.
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Update on regulatory reforms from the Scientific Evaluation Branch
- 1. Update on regulatoryreforms from the Scientific Evaluation Branch Jenny Burnett Scientific Operations Management Section Scientific Evaluation Branch Medicines Regulation Division, TGA ARCS August 2019, Sydney
- 2. Outline • The lateston variations • Generic Medicines Reform Program • Human cells and tissue regulation (excluded goods) • Faecal Microbiota Transplantation • 2D DataMatrix codes for medicines 1
- 3. The latest onvariations 2
- 4. Variations to registeredmedicines Our philosophy is – Continuous improvement Thoughts from last year… • Possible new notifications • Enhancements to the e-form • More moves from paper to electronic applications So what happened next?? 3
- 5. Possible new notifications? •Requires amendment to the Regulations • Legislation changes require consultation • More complex situations … – Variations affecting Product Information Complex from regulatory perspective other projects affecting PIs already underway – Changes to low risk ingredients Requires an Act amendment Complexity = Time delay 4
- 6. Now the goodnews! Enhancements to the e-form for prescription medicines • Clarity on retaining existing AUST R number • ‘associated changes’ • Automated removal of manufacturers with invalid GMP Updated guidance • Multiple related changes • Multiple unrelated changes • Considerations prior to submission 5
- 7. “We have multiplechanges …” New separate and distinct goods? New AUST R? Associated changes Z codes Any link between the changes? An ‘event’ Consequential or related changes Same aspect of the goods 6
- 8. The importance of‘conditions’ • Conditions listed under each variation type • Notification/ SAR conditions not met requires category 3 application Example LOTG: Label - changes to comply with current TGOs for labels that have previously been evaluated and approved by the TGA Conditions • There must be no other changes to the label made under this change request. • The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice. If conditions not met LCDE: Label changes - any changes requiring data for evaluation 7
- 9. More good news!! Moreapplications can be made using the e-form • Extension of Indications for generic medicines • Formulation changes - flavours, fragrances, inks 8
- 10. • The lateston variations • Generic Medicines Reform Program 9
- 11. A program ofreforms Public consultation • Revised requirements for use of an overseas reference product • New templates for bioequivalence data • New process for ‘early advice’ • Incentives for medicines of special interest
- 12. Use of anoverseas reference product • The overseas reference product must be identical to the Australian reference product • Evidence required includes: Product labels Dissolution data Physical characteristics Quantitative analysis of components What evidence should be provided to demonstrate identicality of reference products? 11
- 13. Consultation Outcomes Use ofoverseas reference product • Feedback – Reduce Australian-specific requirements – Harmonise with other regulators where possible – Must not adversely affect quality and safety of generic medicines supplied in Australia • Outcome – Develop a risk-based approach – Reduced requirements for simple, low risk products – All current requirements remain for higher risk medicines 12
- 14. New templates forbioequivalence (BE) data International templates • Internationally-used templates will: – Create greater consistency – Provide a checklist for applicants • We have identified the following international templates: – Bioequivalence study information – Biowaiver justification templates 13
- 15. Consultation Outcomes BE templates •Feedback – Some support for adopting internationally-used templates – Must not result in additional re-work of dossiers for submission to the TGA – Align with EU and ICH requirements, remove Australian-specific requirements • Outcome – Drafted 3 new templates based on those developed by comparable overseas regulators – Created new guidance material – Considered implications for dossier content 14
- 16. New process for‘early advice’ Early advice on biowaiver justifications Aspects to be considered: • Explicit and limited number of technical issues specific to biowaiver justifications • No additional regulatory burden • Possible future broader use 15
- 17. Consultation Outcomes Early adviceprocess • Feedback – All submissions were supportive – Advice needs to be ‘binding’ – Appropriate that a fee is charged – Should be available for a range of topics • Outcome – Amendment to the Therapeutic Goods Act 1989 – Restricted to biowaiver justifications (in the first instance) – Need industry involvement to ensure ‘fit for purpose’ 16
- 18. Generic medicines ofspecial interest How to ensure robust supply? Encourage applications … – Faster evaluation time? – Queue jump? Case study 1. Medicine shortages Case study 2. Medicine expenditure 17
- 19. Consultation Outcomes … takinga different approach • Feedback – Mixed responses … with concerns – No clear benefit for either case study – More efficient TGA processes would be of greater benefit to all – Fast processing of manufacturer changes would assist with medicine shortages • Outcome – Consideration of further reform to the variations process for prescription medicines – Applies to all Rx medicines, therefore outside the Generic Medicines Reform Program 18
- 20. Next steps … Targetedconsultation • Revised requirements for use of an overseas reference product • New templates for bioequivalence data • New process for early advice • Updated guidance • Draft templates and guidance • Confirm key concepts
- 21. • The lateston variations • Generic Medicines Reform Program • Human cells and tissues regulation (excluded goods) 20
- 22. Types of therapeuticgoods Medicines • prescription medicines • over-the-counter medicines • complementary medicines • blood, blood components and plasma derivatives • gene therapies Medical devices • implants (artificial hips, breast implants) • in-vitro diagnostics (pregnancy tests, blood glucose monitors) • low risk medical devices (bandages, tongue depressors, condoms) Biologicals • tissue-based products (skin and bone) • cell-based products (MSCs) • viable animal cells and organs 2
- 23. What is anexcluded good … Excluded vs exempt goods • Excluded – Not subject to the Therapeutic Goods Act 1989 Not to be confused with… • Exempt – Some requirements are not applied Defined in a legislative instrument Therapeutic Goods Regulations 1990 Schedule 5 – exempt from being on the ARTG Schedule 7 – exempt from GMP licence 22
- 24. Therapeutic Goods (ExcludedGoods) Order - pre 2019 Autologous cells and tissues (Medical practice) • collected under the care of a medical practitioner • manufactured for treatment of a single indication • in a single course of treatment of that patient by the same medical practitioner, or by a person under their supervision –Not in alignment with most overseas regulators –Multiple concerns with this approach Review of this position was needed 23
- 25. Review of ExcludedGoods Order • Concerns raised with current Order – Advertising claims for unproven therapies – Scope of activity and complexity of products has changed since 2011; increasing safety concerns – Scope of exclusion is not internationally aligned • Public consultation on options in 2015 and 2016 • Government agreement to an option supported by the majority of stakeholders in 2018 • 12 month transition period to allow operators to comply with the new regulations or cease supplying ended on 1 July 2019. 24
- 26. Autologous Human Cellsand Tissues Excluded Goods • Must be manufactured and used in an accredited hospital • Medical or dental practitioner Exempt Goods • Minimally manipulated and homologous use • Manufactured and used outside a hospital • Medical or dental practitioner Full Regulation • Manufactured and used outside an accredited hospital • More than minimally manipulated, or • For non- homologous use 25
- 27. • The lateston variations • Generic Medicines Reform Program • Human cells and tissues regulation (excluded goods) • Faecal Microbiota Transplantation 26
- 28. Faecal Microbiota Transplantation(FMT) • Takes faecal material from a healthy individual for transplant to a patient • Hypothesis: ‘Healthy’ microbiota correct the underlying dysbiosis associated with disease state – Fresh, frozen, encapsulated – Varying degrees of processing – Allogenic vs autologous – Stool banks Donor • Pre-screened Processing • Testing • Processing • storage Patient • Administered under medical supervision 27
- 29. FMT – anew regulatory challenge • Medicine or biological? – Different regulatory requirements – Different safety considerations – Different approaches overseas • No goods on the Register • Increasing use within Australia • Recognised treatment for Clostridium difficile infection UNAPPROVED BIOLOGICAL 28
- 30. The Biologicals Framework Regulatedas biologicals Tissue-based products (skin, bone, ocular, cardiovascular) Cell-based products (T cell therapies, human stem cells) Combined cell and tissue products (collagen matrices for localised cell delivery) Living animal cells, tissues, organs (xenotransplantation) Not regulated by the TGA Fresh viable organs Assisted reproductive technologies (in vitro fertilisation) Fresh haematopoietic progenitor cells (bone marrow transplants) Cells and tissues made in an accredited hospital, by a medical or dental practitioner, for autologous use in a single patient under the care of that medical practitioner Regulated, but not as biologicals Animal tissue products (non-viable) Biological prescription medicines (vaccines, plasma derivatives) Labile blood and blood components Haematopoietic progenitor cells (non- fresh transplants) 29
- 31. Critical considerations … •Need for GMP • Infectious disease transmission – Donor selection and screening – Current TGO 88 – In vitro diagnostic tests • No advertising of biologicals • Continued supply for existing patient groups • Rapid growth and evolution in the sector 30
- 32. Access to unapprovedbiologicals Biologicals that, under the Regulations, are exempt from some requirements Special Access Scheme Authorised prescriber Personal importation For experimental use 31
- 33. … for newregulatory scheme Possible approaches – Class 1 biologicals? – Alignment with haematopoietic progenitor cells? – Alignment with autologous human cell and tissue products? – Self-regulation? 32
- 34. • The lateston variations • Generic Medicines Reform Program • Human cells and tissue regulation (excluded goods) • Faecal Microbiota Transplantation • 2D DataMatrix codes for medicines 33
- 35. Changing regulatory requirements Overseas •EU - Falsified Medicines Directive • India – export requirements • Track and trace models – Turkey – Argentina – South Korea … 34
- 36. In Australia … TGO91 for prescription medicines –Machine readable code –GTIN and product identifiers – GS1 Linear barcode or 2D DataMatrix –Transition ends Sept 2020 How can these requirements align with overseas requirements??? 35
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- 38. New Australian standard Timelinefor implementation • Pre-consultation workshop • Draft new standard and supporting documentation • Public consultation on draft standard • Finalisation of standard • Target date – mid-2020 37
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