Regulatory Reform - Are we heading in the right direction?
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Regulatory Reform - Are we heading in the right direction?
- 1. Regulatory Reform: Are we heading in the right direction? Trisha Garrett, Assistant Secretary, Complementary and OTC Medicines Branch 11 November 2015
- 2. Where are we going?
- 3. Update TGA Update 1. TGA restructure 2. Government agenda on “Innovation and Competitiveness, and regulatory reform” 3. Improving Complementary Medicines processes within the existing framework 4. Complementary and OTC medicines manufacturing 5. Labelling and Packaging review
- 4. 1. TGA restructure Regulatory Services Group Structure Deputy Secretary TGA Office of Chemical Safety Office of Gene Technology Regulator
- 5. 1. TGA restructure TGA Structure TGA Medicines Regulation Division Complementary and OTC Medicines Branch Pharmacovigilance and Special Access Branch Prescription Medicines Authorisation Branch Scientific Evaluation Branch Medical Devices and Product Quality Division Laboratories Branch Manufacturing Quality Branch Medical Devices Branch Regulatory Practice and Support Division Regulatory Engagement and Planning Branch Regulatory Services and Improvement Branch Regulatory Practice, Education and Compliance Branch
- 6. 1. TGA restructure Medicines Regulation Division PMAB (Prescription Medicines Authorisation Branch) COMB (Complementary and OTC Medicines Branch) Management and Operations Complementary Medicines Evaluation Listing Compliance Over-the-Counter PSAB (Pharmacovigilance and Special Access Branch) SEB (Scientific Evaluation Branch)
- 7. 2. Government agenda on “Innovation and Competitiveness, and regulatory reform” Government commitment: Broadly, there are two types of reforms: • Improving processes within existing framework • Policy change
- 8. 2. Government agenda on “Innovation and Competitiveness, and regulatory reform” Review of Medicines and Medical Devices Regulation – Stage 1 • The first Report of the Review of Medicines and Medical Devices Regulation was publicly released on 24 June 2015. • 32 recommendations against a set of principles and frameworks and suggests potential changes to legislation, processes and supporting infrastructure necessary to improve the way medicines and medical devices are regulated in Australia.
- 9. 2. Government agenda on “Innovation and Competitiveness, and regulatory reform” Review of Medicines and Medical Devices Regulation • The Department of Health is seeking input and feedback from stakeholders across industry associations, consumer groups, and clinical and professional groups. • The purpose of the forums is to engage with stakeholders to understand your views on the benefits and impacts of the recommendations to help inform the Department of Health’s advice to Government.
- 10. 2. Government agenda on “Innovation and Competitiveness, and regulatory reform” Review of Medicines and Medical Devices Regulation • Government response to recommendations are expected towards the end of 2015. • Publication of Part 2 relating to complementary medicines and advertising will be announced by Government. • More information: health.gov.au – Expert-Review-of-Medicines-and-Medical-Devices-Regulation
- 11. 2. Government agenda on “Innovation and Competitiveness, and regulatory reform” New Regulator Performance Framework • A new Regulator Performance Framework was released in November 2014, comprising six outcomes-based key performance indicators (KPI’s) • The Framework also comprises measures of good regulatory performance to be used by all regulators to assess their achievement of the KPIs • Processes exist within the Framework for external validation of regulators’ self-assessments, e.g. annual certification and targeted external review every three years
- 12. 2. Government agenda on “Innovation and Competitiveness, and regulatory reform” Key performance indicators 1. Regulators do not unnecessarily impede the efficient operation of regulated entities 2. Communication with regulated entities is clear, targeted and effective 3. Actions undertaken by regulators are proportionate to the regulatory risk being managed 4. Compliance and monitoring approaches are streamlined and coordinated 5. Regulators are open and transparent in their dealings with regulated entities 6. Regulators actively contribute to the continuous improvement of regulatory frameworks
- 13. 2. Government agenda on “Innovation and Competitiveness, and regulatory reform” Implementation of the new framework • Consultation with TGA-Industry Consultative Committee • Approval by the Minister for Health following agreed formal stakeholder consultation • Develop any necessary data capture processes • The first assessment period is the 2015-16 financial year • The first report will be delivered in August 2016
- 14. 3. Improving Complementary Medicines processes within the existing framework Improving processes within existing framework • International work sharing • Permissible ingredients for use in listed medicines - Implementation of 26BB of the Therapeutic Goods Act 1989 • Complementary Medicines Business Process Reform • Over-the-Counter Business Process Reform
- 15. 3. Improving Complementary Medicines processes within the existing framework International Work Sharing The TGA continues to work with partner agencies on a range of activities: Australia, Canada, Singapore and Switzerland to identify opportunities for the evaluation of the safety of new substances; and New Zealand and Canada on OTC medicines.
- 16. Ingredients Section 26BB inserted into Act, 2009 • Single source of truth • All ingredients (active and excipient) and requirements • Publicly accessible • Simple • Transparent
- 17. 3. Improving Complementary Medicines processes within the existing framework Ingredients list: Therapeutic Goods Permissible Ingredients Determination 2015 (No 1) The 26BB list includes all relevant requirements for ingredients for listed medicines.
- 18. 3. Improving Complementary Medicines processes within the existing framework Changes to the Regulations • 26BB Consequential changes • Therapeutic Goods Regulations: – Schedule 4 (Eligibility for listing) – Schedule 9 (Fees) – Regulation 3AA (RASML)
- 19. CM BPR – new portal and processes • Business Process Reform • Expert Review of Medicines and Medical Devices Partnership to achieve high quality applications and more predictable timeframes
- 20. OTC BPR • Improved target times for OTC evaluations • Updated guidance material • Revised fees commencing 1 January 2016
- 21. 4. Complementary and OTC Medicines Manufacturing GMP Inspections: risk based framework New risk framework: • Product and manufacturing risk matrix will be adjusted to reflect TGA experience (e.g. listed medicines will be Low Risk) • Compliance history – reduced reinspection frequencies for manufacturers with repeat A1 ratings • Reinspection frequencies – different for registered vs listed medicines (listed medicines up to 48 months for repeat A1 ratings)
- 22. 4. Complementary and OTC Medicines Manufacturing GMP Inspections: risk based framework Complementary Medicines manufacturing quality guidelines • TGA Industry Working Group on GMP to develop guidelines on how TGA will apply PIC/S guidelines to take into account issues specific to the Australian market and/or specific product types • Currently working on Complementary Medicines and Sunscreen specific matters
- 23. 5. Labelling and Packaging review Medicines labelling review Aims to address problems: • Expression of active ingredients • Allergies to excipients • CMs and interactions with other medicines
- 24. 5. Labelling and Packaging review Current status: Labelling review • Finalised review of submissions received during the 2014 consultation • Revised draft labelling Order and Guidance • “What’s different” document • Decision RIS
- 25. ARE WE THERE YET?
- 26. Conclusion: already on our way • International harmonisation and information sharing • Streamlining of business processes • Review will inform future reforms • Updated guidance
Editor's Notes
- Recent TGA restructure – OTC now a part of Complementary Medicines Branch
- It is envisioned that this will enable: use of safety evaluations conducted by partners sharing of evaluation workloads resolution of technical problems by specialists in different agencies expedited application processing times across all agencies.
- Key messages The creation of the permissible ingredients list under 26BB of the Act will not change the regulatory requirements or relevant fees for sponsors, and will not affect the regulatory status of any complementary medicines. This work will increase transparency and reduce complexity by creating a single, consolidated, transparent and publicly available list of all ingredients and their associated requirements. We are keen to engage with industry to ensure the list is correct, up to date and fit for purpose The implementation of the 26BB list does not result in a ‘new approach’ to the evaluation process or eligibility for listing requirements. It is also not a ‘new’ approach in terms of the legislative mechanism that allows for the creation of the 26BB legislative instrument. A suite of changes to the Act, which included 26BB and related legislation, was originally consulted with industry representative bodies in 2006/2007. The creation of the legislative instrument allows for a single, consolidated source of truth, with all relevant requirement being included in the list. It will be made publicly available on the Federal Register of Legislative Instruments (FRLI) and be subject to Parliamentary scrutiny.
- Key messages The creation of the permissible ingredients list under 26BB of the Act will not change the regulatory requirements or relevant fees for sponsors, and will not affect the regulatory status of any complementary medicines. This work will increase transparency and reduce complexity by creating a single, consolidated, transparent and publicly available list of all ingredients and their associated requirements. We are keen to engage with industry to ensure the list is correct, up to date and fit for purpose The implementation of the list will not have any impact on sponsors, other than to clearly capture ingredients that are available for use in listed medicines. The List The 26BB list is a comprehensive list that includes all active and excipient ingredients, including ingredients used in PIs. Ingredients are listed individually using their internationally recognised name wherever practicable. The list specifies: How the ingredient is to be used in the medicine, e.g. active or excipient Route of administration, for example as a topical or oral use Concentration/volume limits Container, packaging or labelling requirements, e.g. allergen advice. The implementation of the list will not have any impact on sponsors, other than to clearly capture ingredients and their restrictions that are available for use in listed medicines. I thought I would bring your attention to a few key points: The list also captures requirements from all regulatory sources, including the Poisons Standard and RASML. This means that the list should provide a single comprehensive legislative source for all ingredients and their requirements. The list will be the legislative basis underpinning the Electronic Listing Facility. Requirements have been written as simply as possible while ensuring readability, legislative integrity and as much freedom from ambiguity and contradiction as possible. Proprietary ingredients have not been included in the list. Rather, the ingredients that would form part of those Proprietary ingredients, have been included. For example, the Parent PI such as ‘Flavour X’ is not included in the list as there is no legislative basis for using PIs. However, all the child ingredients that would go into Flavour X are captured in the list. Next steps Once the list is ready, it will be incorporated into a Legislative Instrument which we are able to create under subsection 26BB(1) of the Act. The Legislative Instrument is currently being developed in conjunction with the Office of Parliamentary Council. The Legislative Instruments Act 2003 requires legislative instruments to be registered on the Federal Register of Legislative Instruments (which is accessed via the ComLaw website) and tabled in Parliament. An explanatory statement is also being prepared for the legislative instrument. Legislative instruments are normally disallowable, which means that either House of Parliament may stop their operation by a vote within a set period after they have been tabled.
- Key messages The creation of the permissible ingredients list under 26BB of the Act will not change the regulatory requirements or relevant fees for sponsors, and will not affect the regulatory status of any complementary medicines. This work will increase transparency and reduce complexity by creating a single, consolidated, transparent and publicly available list of all ingredients and their associated requirements. We are keen to engage with industry to ensure the list is correct, up to date and fit for purpose Evaluation process Our internal evaluation process for ingredients will not change as a result of the implementation of the legislative instrument. Applications will still be received and evaluated as they currently are. We are expecting that the MMDR (Medicines and Medical Device Review) will result in recommendations relating to the evaluation of ingredients. The CMBPR process will involve the creation of ingredient application categories that will have an associated timeframe. These changes are likely to result in a more streamlined, improved evaluation process with a greater emphasis on the use of international evaluations. However, the 26BB legislative instrument will not have this sort of impact. Instead it captures all available ingredients which will be useful, regardless of any changes to the framework. Making ingredients available for use In terms of the process of making the ingredients available for use: 1. Applications will still be received via current arrangements. 2. Once an ingredient has been approved, the sponsor will be notified of this decision. 3. Before it becomes legally available for use, it must be added to the 26BB legislative instrument and made available on FRLI. This differs from the current process where individual ingredients are made available through individual listing notices. In creating a single legislative instrument and moving away from listing notices, consideration has been given to what this would look like for industry and any resulting cost-recovery implications. In considering the legislative process involved, the best approach would be to update the list four times a year. The CMBPR process will ensure that timeframes and cut off dates for inclusion in the each update to the list will be made very clear and transparent to allow you to factor this into your business processes.
- Aim: Was to address problems identified over last decade, including: Inability to identify active ingredients and their amounts Confusion about what actives are present in a range of products Allergies to excipients Important: complementary medicines and potential for drug interactions Main changes impacting on Complementary medicines Active ingredients proposed to be removed from the fronts of labels More excipients that must be declared (e.g. crustacean, egg, fish, sesame, soya and tree nut products, potassium and sucralose) Homeopathic medicines vs homeopathic ingredients Clarification of quantities of herbal ingredient (extract and equivalent fresh/dry weight)