Expert review of medicines and medical devices regulation: Prescription medic...TGA Australia
This presentation outlines proposals for implementation of several recommendations from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, and the use of overseas assessment reports.
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
Overview of the Complementary Medicines regulatory frameworkTGA Australia
This presentation provides an overview traditional Chinese Medicines with the complementary medicines regulatory framework and the future of complementary medicine regulation
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Expert review of medicines and medical devices regulation: Prescription medic...TGA Australia
This presentation outlines proposals for implementation of several recommendations from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, and the use of overseas assessment reports.
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
Overview of the Complementary Medicines regulatory frameworkTGA Australia
This presentation provides an overview traditional Chinese Medicines with the complementary medicines regulatory framework and the future of complementary medicine regulation
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
How do listed medicines shape up in the post market compliance spaceTGA Australia
This presentation provides an overview of the TGA’s post-market compliance program and how data from the program is used to manage non-compliance and highlight areas of concern.
Presentation: Risk minimisation in the Australian contextTGA Australia
This presentation describes Risk Minimisation including general principles and the tools available for the development of Risk Minimisation Plans (RMPs)
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
Regulation of cell and tissue therapies and clinical research in AustraliaTGA Australia
This presentation provides an overview of biologicals including the process for inclusion on the Australian Register of Therapeutic Goods, and the regulation of clinical trials in Australia.
Presentation: What's trending in medicines regulation? A January 2017 reflectionTGA Australia
This presentation provides a local perspective on recent developments in the medical technology and pharmaceutical landscape, and the future of the TGA in a global context.
Presentation: Spotlight on prescription medicines reformsTGA Australia
An overview of initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines as well as orphan drugs and developments for eCTD and the new MedSearch app.
Presentation: Transparency initiatives and the TGATGA Australia
This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.
This presentation provides an overview of proposals for implementation of several reform initiatives relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, the use of overseas assessment reports, and reforms to the orphan drug programs. The information session was held ahead of formal public consultations to provide an early view of the reform proposals to those stakeholders who will be most directly involved in the design of the new regulatory arrangements.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview of the regulation of autologous cells and tissues in Australia, including a discussion on emerging examples of practices that have the potential for increased risk.
TGA presentation: Provisional approval pathway for prescription medicinesTGA Australia
This presentation provided an overview of some of the reform activities relevant to prescription, OTC and complementary medicines and implementation of recommendations from the Review of Medicines and Medical Devices Regulation including the content of the consultations on enhancements
How do listed medicines shape up in the post market compliance spaceTGA Australia
This presentation provides an overview of the TGA’s post-market compliance program and how data from the program is used to manage non-compliance and highlight areas of concern.
Presentation: Risk minimisation in the Australian contextTGA Australia
This presentation describes Risk Minimisation including general principles and the tools available for the development of Risk Minimisation Plans (RMPs)
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
Regulation of cell and tissue therapies and clinical research in AustraliaTGA Australia
This presentation provides an overview of biologicals including the process for inclusion on the Australian Register of Therapeutic Goods, and the regulation of clinical trials in Australia.
Presentation: What's trending in medicines regulation? A January 2017 reflectionTGA Australia
This presentation provides a local perspective on recent developments in the medical technology and pharmaceutical landscape, and the future of the TGA in a global context.
Presentation: Spotlight on prescription medicines reformsTGA Australia
An overview of initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines as well as orphan drugs and developments for eCTD and the new MedSearch app.
Presentation: Transparency initiatives and the TGATGA Australia
This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.
This presentation provides an overview of proposals for implementation of several reform initiatives relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, the use of overseas assessment reports, and reforms to the orphan drug programs. The information session was held ahead of formal public consultations to provide an early view of the reform proposals to those stakeholders who will be most directly involved in the design of the new regulatory arrangements.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview of the regulation of autologous cells and tissues in Australia, including a discussion on emerging examples of practices that have the potential for increased risk.
TGA presentation: Provisional approval pathway for prescription medicinesTGA Australia
This presentation provided an overview of some of the reform activities relevant to prescription, OTC and complementary medicines and implementation of recommendations from the Review of Medicines and Medical Devices Regulation including the content of the consultations on enhancements
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
Regulatory Update Panel
An overview of all Health Canada policies supporting access to Drugs for Rare Diseases, including regulatory pathways and support for innovation, patient engagement, Special Access Programs, aligned HC/CADTH/INESSS, international harmonization, post-market monitoring, support for patient registries, current status and relevance of biosimilars for rare disease patients
Rare Disease Day Conference 2020 March 9-10
The world of Regulatory convergence: an Australian reflectionTGA Australia
This presentation provides an overview on recent advances and initiatives on regulatory convergence and the impact on Australian, European and international regulation of therapeutic goods.
Presentation: Improving the regulation of generic medicines in AustraliaTGA Australia
The registration system for generic prescription medicines has not been amended since the introduction of the Streamlined Submission Process in 2010 and assigns all generics the same target timeframe of 255 working days. Amendments to the generic medicine registration process are under discussion that could provide for flexibility for certain applications and better support the timely availability of high quality generic medicines and the sustainability of the Australian health system.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
A Rare International Dialogue (Saturday May 11, 2019)
Drivers of Drug Development – Regulatory Collaboration
Canada’s regulatory approach to drugs for rare diseases - Fiona Frappier, Health Canada
International regulatory cooperation: more important than everTGA Australia
The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers the importance and future of international regulatory cooperation
Presentation: Global pharmacovigilance networks - A regulator'sTGA Australia
Global pharmaceutical companies manufacture and distribute a broad portfolio of drug products in multiples regions and countries. The pharmacovigilance system must ensure safety data collection in compliance with local regulations, and consolidate all sources to ensure an ongoing monitoring of potential changes in benefit-risk profiles. It must also guarantee a timely communication to patients, prescribers and regulatory authorities. The complexity resides in the need for a dense network of local safety departments, a strong global organisation processing and analysing cases, and a reporting system ensuring compliance to heterogeneous regulatory requirements. Pfizer has one of the largest pharmacovigilance department among all global companies, and has established patient safety as a core priority. We will describe how pharmacovigilance is organised at Pfizer, global compliance and individual patient safety.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Updates from the Pharmacovigilance and Special Access Branch TGA Australia
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS)
Q and A
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Presentation Trends in Australian and international regulation and regulatory cooperation
1. Trends in Australian and international
regulation and regulatory cooperation
John Skerritt
Deputy Secretary for Health Products Regulation
Department of Health, Australia
ARCS Scientific Congress Canberra 2016
2. This presentation
• The Health Products Regulation Group
– Therapeutic Goods Administration and the Office of Drug Control
• But first – where is the Medicines and Medical Devices Review up to ?
• TGA Stakeholder Survey 2016
• Recent developments at some of the major overseas regulators
• Update on TGA’s international collaborations
• Conclusion
Trends in Australian and international regulation and regulatory cooperation 1
3. Health Products Regulation Group Structure
2
Prescription Medicines
Authorisation
Complementary and
OTC Medicines
Pharmacovigilance and
Special Access
Medical Devices
Laboratories
Manufacturing Quality
Regulatory
Engagement and
Planning
Regulatory Services
and Improvement
Regulatory Practice,
Education and
Compliance
Medicinal Cannabis
Drug Control
Scientific Evaluation
Health Products Regulation
Group
Deputy Secretary
Principal Medical Adviser
Principal Legal and Policy
Adviser
Department of Health
Secretary
Medicines
Regulation
Medical Devices
and Compliance
Regulatory
Practice and
Support
Office of Drug
Control
Regulatory
Reforms
4. But first…. Where is the MMDR up to ?
“Improving the Regulation of Therapeutic Goods in
Australia” is a May 2016 budget measure
“The Government will provide $20.4 m over four years from
2016-17, including $9.5 m in capital funding, to improve the
regulation of therapeutic goods in Australia in response to the
Expert Panel Review of Medicines and Medical Devices
Regulation. The funding will improve access to therapeutic goods
for consumers and introduce more flexible and timely regulatory
processes for the therapeutic goods industry.”
While this is technically “government” money it is fully industry
funded from TGA reserves and not additional taxpayer funds
Trends in Australian and international regulation and regulatory cooperation 3
5. What was publicly released on budget night ?
www.health.gov.au/internet/budget/publishing.nsf/Content/budget2016-factsheet23.htm
Prescription medicines and medical devices
• Sponsors able to add medicines and devices to the ARTG through new approval pathways
• New medicines such as cancer drugs will enter the market sooner, through new provisional
approvals and making greater use of overseas assessments
• New medicines and devices will be approved faster in certain circumstances, based on
criteria to be developed in consultation with consumers, health professionals and industry
• Assessment times will be reduced by up to three months through utilising work carried out by
comparable overseas regulators
• There will be greater focus on post-market reporting to ensure safety and efficacy is
maintained which will include enhanced electronic reporting and a risk communication strategy
• Commercial bodies approved by the TGA will be allowed to undertake device assessments
Trends in Australian and international regulation and regulatory cooperation
4
6. What was publicly released on budget night ?
Complementary medicines
• A catalogue for approved ingredients and permitted indications will be established
Product access
• Scheduling Policy Framework to be reviewed in consultation with state and territory govts
• Pre-approval will be introduced under Special Access Scheme (B) for low-risk products that
have specific and well-established patterns of use for patients with a non-terminal condition.
Advertising
• Advertising regulations will be more consistent across the range of medicines and devices
• TGA investigation and enforcement powers will be strengthened, and a new compliance
education program for industry will be introduced
Trends in Australian and international regulation and regulatory cooperation 5
7. What was publicly released on budget night ?
www.health.gov.au/internet/budget/publishing.nsf/Content/budget2016-factsheet23.htm
Advisory committees
• The Government will reduce the number of statutory advisory committees that provide
independent expert advice to the TGA from 11 to seven
• The new committees will advise on medical, chemical and scientific matters, market approval of
new therapeutic goods, and product safety issues
Enforcement
• TGA’s enforcement and compliance powers will be strengthened.
• Compliance activities will make greater use of data analytics to target areas of concern
Funding design of the reforms
• Design and IT systems changes will be drawn from reserves in the TGA Special Account.
• An increase in TGA fees and charges will not be required
Trends in Australian and international regulation and regulatory cooperation
6
8. We have started work
• Teams have been established to work on the
government’s decisions in each area
• Strong IT systems design component to the reforms
• Once the Government announces the detailed response
to the review
– Communication materials explaining the government’s intent
will be released
– Stakeholder consultations will commence - consultations will
be clustered to avoid stakeholder overload
• Implementation of several recommendations will require
changes to the Therapeutic Goods Act and/or Regulations
Trends in Australian and international regulation and regulatory cooperation 7
9. TGA stakeholder survey 2016
• A reporting requirement for the Government’s Regulator Performance Framework
• 2810 responses including 449 healthcare professionals, 65 consumers and 1628 from industry
• Results remarkably positive in terms of trust and confidence in the regulator
– 79 % of industry have high/very high confidence in TGA safeguards
– 61 % of community/ consumer groups with 27 % ambivalent/ unsure
• Positive about engagement – (users satisfied or very satisfied) with TGA consultations (63%),
exhibitions (75%) and information sessions (82%) respectively.
• Main area for work is to TGA to engage more actively with consumers
– They are aware of, and have a generally favourable perception of the TGA, but many unsure
– Consumers also felt least engaged in TGA policy consultations
Trends in Australian and international regulation and regulatory cooperation 8
10. Some international regulatory developments
Trends in Australian and international regulation and regulatory cooperation 9
11. Some FDA developments
• FDA-EMA cooperation on inspections, more broadly
• Reduction in fees – NCE only AUD $ 2.7m, generic $ 310 k
• Strong focus on real world data and involvement of patient centred outcomes
• Evaluation of breakthrough designation schemes for medicines
• Biosimilar framework emerging
• Greater use of real world / big data in medicine clinical trials and devices evaluations
• Device reforms – low risk devices exempt from regulation, streamlining device approval times
• Zika virus – blood supply, diagnostics
• Integration of drug and biomarker development for cancers
• Focus on challenging conditions for drug development – e.g. Alzheimers, diabetes
• Concerns re prescription opioid abuse
Trends in Australian and international regulation and regulatory cooperation
10
12. Some EMA developments
• PRIME (PRIority MEdicines) system – enhance development of
medicines that target unmet medical need – proactive early dialogue
• Review of experience with provisional / adaptive licensing pathways
• Enhancement of scientific advice to medicines developers around clinical trial design
• Parallel scientific advice with European Health Technology Assessment Bodies
• Increased focus on transparency, especially access to clinical trials data
• Review of regulation of “first in man” clinical trials
• Focus on updating safety advice for medicines
• Track and trace of medicines throughout the supply chain
• Approval on-line pharmacies (easily recognisable logo)
• BREXIT and future location of the EMA ?
• New European medical devices/ IVD regulatory framework inches forward
Trends in Australian and international regulation and regulatory cooperation
11
13. Some PMDA Japan developments
• Now has the fastest average medicine approval time globally
following tripling of evaluator staff over the last decade
• New regulatory framework for innovative products (SAKIGAKE)
• Provisional licensing of cell and tissue therapies
• Increased amount of information published in English, but most evaluations only in Japanese
• Increased emphasis on funding regulatory research projects and collaboration with
universities and research institutes
• Innovative approaches to post-market pharmacovigilance
– stimulated reporting for new medicines
– publication of risk management plans
– MIHARI collaboration on the use of electronic health data
Trends in Australian and international regulation and regulatory cooperation 12
14. Some HPFB Canada developments
• Strong emphasis on regulatory transparency
– GMP Inspection information and reports published
– Enforcement information such as advertising complaints
– Publishing information on NCEs under review
– Information on positive and negative decisions for medicines and high-risk medical
devices, and summary of basis of decision
– Increased powers to disclose safety risks and recalls
• Requiring healthcare institutions (as well as sponsors) to report adverse events
• Plain language medicines labelling
• Mandatory reporting of, and expanded information on medicines shortages
Trends in Australian and international regulation and regulatory cooperation 13
15. Australia is the only country we know where international
regulatory cooperation is formal Government policy
“ if a system, service or product has been
approved under a trusted international
standard or risk assessment, then our
regulators should not impose any
additional requirements for approval in
Australia, unless it can be demonstrated
that there is a good reason to do so”.
Prime Minister’s media release 14 October 2014
16. GMP inspection collaboration
• Involvement in PIC/S
• Widespread use of GMP clearances already significantly reduces the number
of overseas inspections required
• More joint inspections with other regulators being undertaken
• Mechanisms to improve sharing of confidential information such as
inspection plans and reports being developed through ICMRA
15
17. International Coalition of Medicines
Regulatory Authorities (ICMRA)
• First regulatory coalition at agency head level – commenced Dec 2013
– 23 countries plus EMA, EU and WHO
• Initial projects completed:
– Establishment and governance
– Generic medicines information sharing and commercial-in-confidence processes
– Documentation of capacity building initiatives
• Projects underway
– Establishment of systems to enable GMP Inspection reports from one regulator to be
recognised by a second regulator – avoid need for separate inspection
– Pharmacovigiliance collaboration
– Supply chain security and crisis management 16
18. ICMRA Pharmacovigilance project
• Identify areas for sharing of learnings and structured collaboration
• Assist policy discussions by agency heads (and subject experts)
• There are well-established national and WHO pharmacovigilance systems, and this
project is NOT about establishing new systems
• Three priorities were identified for initial work:
– How to best utilise “big data” for pharmacovigilance purposes?
– What policy approaches are most successful in increasing the rates of adverse events
reporting, in particular from health care professionals?
– Are there workable approaches by which the existing pharmacovigilance systems can
be better linked?
Trends in Australian and international regulation and regulatory cooperation
17
19. A practical implementation approach to test feasibility of worksharing
– complements bilateral cooperation with Canada
• Common template and safety assessment of complementary medicine ingredients
• First worksharing trial for a generic medicine underway
• Information sharing on New Chemical Entity submissions and planning for worksharing
• Good review practices, Risk benefit assessment and communication methodology
• Manufacturing compliance and joint inspections
• Secure portal for confidential information exchange developed
• Staff exchanges 18
20. Dr Mariana Gebara-Coughlan will
talk more about IGDRP in a
separate ARCS presentation
• Australia, Brazil, Canada, Chinese Taipei, CMDh (EU), EDQM, Japan, Korea, Mexico,
Singapore, South Africa, Switzerland, USA, WHO
• Comparison of review process – legislation, key regulatory guidelines, phases of the
application process, timelines, user fees
• IT platform and central repository
• Information and Work Sharing models - sharing of assessment reports in “real time”
• Quality Working Group - establish frameworks and mechanisms for information
sharing and work sharing on quality – ASMF / DSMF
• Bioequivalence - develop tools to aid in assessment, cooperation on biowaivers 19
21. Collaboration with other regulators is already
happening with generic medicines
• Since late 2013, several generic medicines have been registered by TGA following
the exchange of reviews with Health Canada
• TGA involvement in a pilot of EU Decentralised Procedures for evaluation of
applications now extended to those submitted through the Centralised Procedure
• ACSS worksharing pilot underway – TGA evaluation reports shared with other
agencies for their assessment
• Generics cooperation is also a test case for broader cooperation between regulators
on New Chemical Entities (New Prescription Medicines)
Trends in Australian and international regulation and regulatory cooperation 20
22. How could use of an international evaluation speed
evaluation of a new prescription medicine?
A range of alternatives exist:
1. Work sharing - If two regulators received the same application, share
workload by evaluating different parts of the dossier
2. Information sharing – use of the evaluation report of another trusted
regulator to reduce re-work
3. Streamlined acceptance based on a decision by a trusted regulator
• Some countries (e.g. Singapore, Mexico, Taiwan) already provide industry
with a range of alternatives like these
• Timely sharing of reports critical for faster review – otherwise it’s slower !
Trends in Australian and international regulation and regulatory cooperation 21
23. How could streamlined acceptance based on a
decision by a trusted regulator potentially work ?
• Where the overseas regulator has approved the same medicine, TGA could
avoid (re-)evaluation of its quality, safety or efficacy
• Only the Australian-specific requirements would be assessed, e.g.:
– Product Information, Consumer Medicine Information
– Australian clinical guidelines/ context of use,
– Risk Management plans, Scheduling and Australian labelling requirements
• Would require the company applying for local approval to provide them with the
full data package and full overseas reports on the medicine
• So as to enable the basis of decisions on indications and risks to be understood
and manage potential risks once the medicine is in the market
Trends in Australian and international regulation and regulatory cooperation
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24. • Aims to accelerate international device regulatory
harmonisation and convergence
• Established in 2012 to build on foundational work of
GHTF (Global Harmonization Taskforce on Medical
Devices)
• Members: Australia, Brazil, Canada, China, EU,
Japan, Russia and USA
• Asian Harmonization Working Party and PAHO are
affiliates and WHO and APEC are observers
Trends in Australian and international regulation and regulatory cooperation 23
25. IMDRF Medical Device Single Audit Program
• Pilot to promote greater alignment of regulatory
approaches and technical requirements
• Develop a standard set of requirements for third party
organisations performing audits of manufacturers’ QMS on
behalf of regulators
• Benefits manufacturers through a reduced number of
audits, reduced annual cost, an increase in the predictability
of outcomes, and opportunities for export markets.
• Benefits Sponsors as an additional basis for ARTG entry
• Enable TGA to be focused on problematic devices,
manufacturers that are not in compliance with regulations,
and oversight of third party auditors
Keith Smith will talk
more about MDSAP
in a separate ARCS
presentation
Trends in Australian and international regulation and regulatory cooperation
24
26. Other IMDRF projects
• Development of a comprehensive and consistent Regulated Product
Submission structure as an international format for device evaluation
• National Competent Authority system - to facilitate exchange of post market
safety information
• Harmonised approaches to treatment of Software as a Medical Device
• Integrating Patient Registries for enhanced device evaluation and tracking
• Medical device adverse event terminology
• Good regulatory review practice – competence and training requirements
• Improving quality of international device standards for regulatory use
Trends in Australian and international regulation and regulatory cooperation 25
27. Draft clinical evidence guidelines
Dr Cheryl McRae will
talk more about this in
a separate ARCS
presentation• Significant interest from other international regulators!
• Outline current TGA expectations for:
– clinical evaluation reports
– underlying evidence to be held by medical device manufacturers
• Written for manufacturers and sponsors (also important for clinicians, evaluators)
• Aim is to clarify requirements but not change the requirements
– reduce numbers of errors in clinical evidence reports received by TGA
– multiple rounds of review delays decisions and wastes time and resources
Trends in Australian and international regulation and regulatory cooperation 26
28. Summary
• The MMDR “Improving the Regulation of Therapeutic Goods in Australia”
2016 budget measure sets high-level direction for reforms
– Significant but staged consultation with stakeholders will be undertaken soon
– Several other reforms are also in train – e.g. medicines labelling, orphan drugs, stem
cells, IVD transition
• Priorities of TGA and overseas regulators have much in common
• International regulatory collaboration is Australian Government policy
– TGA is in a leadership role for several initiatives
– In time, there will be benefits for industry, patients and TGA
– Several initiatives in place, but all are dependent on desire from partners to collaborate
– Integration of international collaboration projects into “business as usual” will take time
Trends in Australian and international regulation and regulatory cooperation 27