Expert review of medicines and medical devices regulation: Prescription medicines reforms
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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.
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Expert review of medicines and medical devices regulation: Prescription medicines reforms
- 1. Expert review of medicines and medical devices regulation Prescription medicines reforms
- 2. Prescription Medicines MMDR Reforms Expedited Pathways for Prescription Medicines Adrian Bootes Assistant Secretary Prescription Medicines Authorisation Branch, Medicines Regulation Division Therapeutic Goods Administration ARCS Webinar 13 December 2016
- 3. Review of Medicines and Medical Devices Regulation (MMDR review) • The review was conducted by an expert panel and made 58 recommendations relating to the regulation of medicines, medical devices, post-market monitoring, complementary medicines and advertising of therapeutic goods. • On 15 September 2016, the Australian Government released its response to the MMDR review. • The Government accepted the majority of the review’s recommendations in full or in-principle and announced a program of reform to facilitate their implementation. • The Government response identified the need for consultation with stakeholders in progressing the reforms. ARCS webinar: Prescription Medicines MMDR Reforms 2
- 4. Seven bundles of work agreed and costed • Increasing Flexibility for Registration and Post-Market Processes for Prescription Medicines • Increasing Flexibility for Approval and Enhanced Post-Market Monitoring of Medical Devices • Increasing Flexibility for Pre-Market Approval and Increased Evidence of Efficacy of Complementary Medicines for Consumers • Simplified and More Effective Regulation of Advertising • Streamlined Regulation of Patient Access to Therapeutic Products • Further Reviews • Rationalisation of TGA Statutory Advisory Committees ARCS webinar: Prescription Medicines MMDR Reforms 3
- 5. Indicative timeline Next 12 months • Prescription medicines – use of overseas approvals, Priority Review pathway • Generics – work sharing pathway, use of overseas approvals and reform of pathways • Risk-based approach to medicine variations • Medical devices – overseas notified bodies list (develop approaches) – notified bodies in Australia (build framework) • Patient-Specific Access – category B notifications – simplified authorised prescriber process • Reviews of Scheduling Policy Framework and S3 advertising completed ARCS webinar: Prescription Medicines MMDR Reforms 4
- 6. Indicative timeline By 18 months • Prescription medicines – Provisional Approval pathway • Medical devices – Priority Review pathway – notified bodies in Australia (regulatory change) By 24 months • Prescription medicines – work sharing pathway established • Complementary medicines – permitted indications • Medical devices – overseas notified bodies oversight in place • Patient-Specific Access – online SAS system implemented • New Scheduling Policy Framework and possible S3 medicine changes implemented • Advertising – complaints process and enforcement powers in place • Advertising – pre-approvals ceased ARCS webinar: Prescription Medicines MMDR Reforms 5
- 7. Interdependencies • Implementation planning for the reforms is progressing • First stakeholder consultations have commenced • Delivery of many reforms is dependent on: – feedback from consultations – Inter-related reforms – passage of legislative amendments and regulatory changes ARCS webinar: Prescription Medicines MMDR Reforms 6
- 8. Legislative amendments • First amendment Bill introduced to the lower house • Amendments in this Bill will facilitate: – Regulation-making power to set out details of the Priority Review pathway – Notifications for low-risk variations – Easier access to certain unapproved goods – Conformity assessment of medical devices by Australian companies – Timeframes for decision making for listed complementary medicines – Review and appeal rights for sponsors seeking approval to use new ingredients for listed medicines – Consolidation of TGA advisory committees ARCS webinar: Prescription Medicines MMDR Reforms 7
- 9. MMDR Consultations Public consultations recently closed • Criteria for comparable overseas regulators for prescription medicines (12/12) • Expedited pathways for prescription medicines (12/12) Currently open public consultations (targeted already commenced): • Regulatory framework for advertising therapeutic goods (complaints handling and sanctions and penalties) • Designation of Australian conformity assessment bodies for medical devices • Accelerated assessment of medical devices From January 2017 • Complementary medicines reforms including – Introduction of a new class of assessed complementary medicines – List of permitted indications for complementary medicines 8
- 10. Consultation forecast From February 2017 • Provisional approval for prescription medicines • Enhancements to post-market monitoring scheme for medicines • Medical devices overseas regulatory approvals and criteria for identifying comparable overseas designating authorities and regulators • Special Access Scheme Category B notification criteria • Streamlined process for Authorised Prescriber Scheme applications From March 2017 • Innovation incentives for complementary medicines • Review of the Scheduling Policy Framework • Review of low risk therapeutic products ARCS webinar: Prescription Medicines MMDR Reforms See the MMDR public consultation forecast on the TGA website for further information 9
- 11. Expedited pathways for prescription medicines • The MMDR review recommended that we implement “expedited pathways for promising new medicines in certain circumstances”. • Two new ‘expedited’ pathways are being developed: – Priority Review of a complete data dossier within a reduced timeframe in certain circumstances (target timeframe of 150 working days) – Provisional Approval on the basis of early data on safety and efficacy, where the immediate availability of the medicine outweighs the risk that additional data is still required. • The key objective of the expedited pathways is to facilitate earlier access to medicines that address unmet clinical needs for Australian consumers, without compromising our standards for safety, efficacy and quality. ARCS webinar: Prescription Medicines MMDR Reforms 10
- 12. TGA’s principles for expedited pathways 1. Health professional and consumer confidence in TGA regulation of the safety, efficacy and quality of therapeutic goods must be maintained 2. TGA will provide clear guidance to enable the applicant to adhere to the designation and registration processes 3. Applicants will be responsible for providing TGA with all information necessary to get and support continued designation 4. Both TGA and the applicant will commit to open and timely communication to support expediting the application in the interest of public health benefit 5. There will be transparency of the criteria, and of designation and registration decisions 6. The designation and registration processes will be cost recovered 7. Appeal rights regarding the designation decision will exist 8. The designation and registration processes should not result in an unreasonable diversion of TGA resources from business as usual activities ARCS webinar: Prescription Medicines MMDR Reforms 11
- 13. Proposed eligibility criteria for expedited pathways All three proposed criteria must be satisfied for entry into the expedited pathways • Serious condition the medicine is indicated for the treatment, prevention or diagnosis of a life threatening or seriously debilitating disease or condition; AND • Unmet clinical need the medicine addresses an unmet clinical need in Australian patients; AND • Major Therapeutic Advantage For Priority Review: there is substantial evidence demonstrating that the medicine provides a major therapeutic advantage in efficacy and/or safety over existing treatments that are fully registered in Australia. For Provisional Approval: there is promising evidence from early data indicating that the medicine is likely to provide a major therapeutic advantage in efficacy and/or safety over existing treatments that are fully registered in Australia. ARCS webinar: Prescription Medicines MMDR Reforms 12
- 14. Proposed designation process for expedited pathways Please note: this is a draft process only and will be finalised by the TGA following consultation ARCS webinar: Prescription Medicines MMDR Reforms 13
- 15. Proposed designation process: key details Duration of designation • Sponsors should know whether a medicine is eligible for designation 6-8 weeks prior to submission. • It is proposed that designations for the expedited pathways will lapse if a full submission for registration is not provided within three months of a designation being granted. Appeals • Sponsors will be able to seek internal review of the designation decision. Publication • It is important that there is transparency of designation decisions for the expedited pathways. • We have sought feedback on options for publication of designation decisions as part of the our recent public consultation. ARCS webinar: Prescription Medicines MMDR Reforms 14
- 16. Provisional Approval • Provisional Approval is currently scheduled to be implemented within the next 18 months, subject to consultation feedback, and will involve: – Allowing the TGA to provide provisional registration on the ARTG in the absence of clinical data on safety and efficacy – Provisional registration granted for a specified period of time (currently proposed 2-3 years) – Sponsors will be required to collect and submit post-market safety and efficacy data – Enhanced post-market monitoring and surveillance by both the medicine sponsor and TGA – Medicines may be able to obtain full registration when enough data is provided to confirm adequate safety and efficacy standards The process for Provisional Approval and associated enhanced post-market surveillance is currently being developed. Public consultation on Provisional Approval will occur in 2017. ARCS webinar: Prescription Medicines MMDR Reforms 15
- 17. Priority Review • Priority Review is currently scheduled to be implemented within the next 12 months, subject to consultation feedback, and will involve: – New and flexible business processes to reduce the timeframe for assessing certain medicines with a full data dossier Decision regarding registration in the ARTG to be made more quickly Target of 150 working days recommended by the expert panel, consistent with benchmarks set by the FDA and EMA – More flexible and timely arrangements for seeking external expert advice in order to facilitate the shorter timeframe – Exit pathways if the sponsor does not meet requirements for Priority Review – Full registration in the ARTG ARCS webinar: Prescription Medicines MMDR Reforms 16
- 18. Priority Review: Proposed registration process for consultation ARCS webinar: Prescription Medicines MMDR Reforms 17
- 19. Proposed submission and evaluation phases Please note: this is a draft process only and will be finalised by the TGA following consultation ARCS webinar: Prescription Medicines MMDR Reforms 18
- 20. Proposed expert advisory and decision making phases Please note: this is a draft process only and will be finalised by the TGA following consultation ARCS webinar: Prescription Medicines MMDR Reforms 19
- 21. Questions? Further questions about these reforms can be sent to MMDR.consultation@health.gov.au ARCS webinar: Prescription Medicines MMDR Reforms 20
- 22. Prescription Medicines MMDR Reforms Enhanced Post-Market Monitoring and Unapproved Goods Dr Jane Cook Assistant Secretary Pharmacovigilance and Special Access Branch, Medicines Regulation Division Therapeutic Goods Administration ARCS Webinar 13 December 2016
- 23. Enhanced post-market monitoring scope • TGA intends consulting on a number of enhancements to our Medicines Vigilance Framework in response to MMDR. • This includes the introduction of a number of new vigilance tools. • Like our existing vigilance tools, they will be applied on a risk management basis. • We continue to see post-market monitoring as a collaborative activity TGA shares with sponsors, health professionals and consumers. ARCS webinar: Prescription Medicines MMDR Reforms 22
- 24. Areas for consideration • RMP Compliance Monitoring Program • Black Triangle Scheme ▼ • Pharmacovigilance Inspections Program ARCS webinar: Prescription Medicines MMDR Reforms 23
- 25. RMP compliance monitoring program • TGA to follow up with sponsors where RMP activities have not been completed within the timeframes given in the RMP • Will operate within TGA’s existing Regulatory Compliance Framework, where we will seek to work with the sponsor in the first instance to achieve compliance. • Risk based prioritisation Provisionally registered products First in pharmacological class Identified safety concern of special interest that requires additional monitoring/mitigation ARCS webinar: Prescription Medicines MMDR Reforms 24
- 26. Black Triangle scheme ▼ • To alert health professionals and consumers that the medicine is subject to intensive monitoring by TGA • Encourage health professionals and consumers to report adverse events for medicines in the scheme • Targeted use to maintain potency of the symbol, such as – first in pharmacological class NCEs – new medicines with safety concerns • Will require the assistance of sponsors, health professional and consumer groups to implement the communication strategy to support the Scheme. ARCS webinar: Prescription Medicines MMDR Reforms 25
- 27. Pharmacovigilance Inspections program • Full implementation following the PV Inspection Pilot • Program will apply to Sponsors of: – prescription medicines – over-the-counter medicines – listed and registered complementary medicines • Risk-based prioritisation of sponsors for inspection, considering: – the risk that non-compliance is occurring, and – the potential consequences of this • Again, TGA will take a cooperative compliance approach to work with sponsors in the first instance where there are non-compliance findings ARCS webinar: Prescription Medicines MMDR Reforms 26
- 28. What else? • A new Adverse Events Management System – This will cover both medicine and medical device adverse events. – Will enable system to system exchange of adverse event reports using standardised international message formats such as ICH E2B R2 and R3. This functionality will make it easier for sponsors to send and receive adverse event information to/from the TGA. – Will assist the TGA in enhancing its signal management capabilities through more advanced signal detection and data analysis processes. ARCS webinar: Prescription Medicines MMDR Reforms 27
- 29. Unapproved goods Special Access Scheme (SAS) and Authorised Prescriber (AP) • Legislation will be amended to allow for notifications for identified unapproved therapeutic goods where the patient does not have a life threatening condition. • TGA will implement a list of unapproved goods against which SAS Category B notifications will be allowed. To maintain the integrity of the ARTG, TGA will be responsible for nominating unapproved goods for inclusion on the list. TGA will need to be satisfied that these goods have a history of established use in Australia or overseas for inclusion on the list. • Enhanced compliance processes will be put in place to ensure the scheme is being used as intended. • An online portal will be developed to facilitate improved efficiency in the SAS and AP processes. ARCS webinar: Prescription Medicines MMDR Reforms 28
- 30. Next Steps • Early 2017 – TGA will undertake targeted and public consultation on the proposed changes • January 2018 – RMP Compliance Monitoring comes into effect – Black Triangle Scheme comes into effect – New online adverse event reporting system goes live • July 2018 – New online system for unapproved goods goes live – Pharmacovigilance Inspection Program comes into effect ARCS webinar: Prescription Medicines MMDR Reforms 29
- 31. Questions? Further questions about these reforms can be sent to MMDR.consultation@health.gov.au ARCS webinar: Prescription Medicines MMDR Reforms 30
- 32. Prescription Medicines MMDR Reforms Scientific Evaluation Branch Rochelle Christian Assistant Secretary Scientific Evaluation Branch, Medicines Regulation Division Therapeutic Goods Administration ARCS Webinar 13 December 2016
- 33. Medicine regulation reforms Scientific Evaluation Branch - 3 of 5 projects Work-sharing – Simultaneous submissions to multiple agencies – Independent decision-making Use of overseas assessment reports – Submitted by the applicant in Australia – Complete reports, unredacted Variations to registered medicines – a risk-based approach – A notification process for negligible-risk changes ARCS webinar: Prescription Medicines MMDR Reforms 32
- 34. Use of overseas reports and work-sharing Scope • Identify ‘Comparable Overseas Regulators’ – Consultation on criteria • Further developing business processes – Work-sharing – COR reports submitted by applicant in Australia • Build on existing cooperation initiatives, e.g. – Australia-Canada Regulatory Cooperation Initiative – International Generic Drug Regulators Programme Benefits • Removing ‘submission lag’ • Reducing evaluation times • Aligning regulatory requirements between regulators ARCS webinar: Prescription Medicines MMDR Reforms 33
- 35. Variations to registered medicines – risk-based • ‘Notification’ rather than ‘request for variation’ – Staged implementation – Review of existing change codes – Amendment to therapeutic goods legislation – Appropriate fees • Applies to all registered medicines – Enhancements to existing portal for non- prescription medicines – New e-form for prescription medicines ARCS webinar: Prescription Medicines MMDR Reforms 34
- 36. Questions? ARCS webinar: Prescription Medicines MMDR Reforms 35
Editor's Notes
- The Government accepted the recommendations to streamline TGA’s registration processes and improve timely access by Australian consumers to new medicines and medical devices. In order to maintain continuity of business, implementation of recommendations will occur in a staged approach over the next 12-24 months, with new regulatory pathways for some medicines in place within the next 12 months.
- Primarily two forms of consultation: public consultation targeted consultation Public consultation will be typically open for six weeks Some consultations may need to occur over summer due to the tight program for design of reforms and potential development of amendments to legislation The public consultations on: criteria for comparable overseas regulators for prescription medicines; and the eligibility criteria and designation process for the expedited pathways for prescription medicines closed COB yesterday, 12 December. Thank you to those who provided the TGA with submissions to one or both of these public consultations. We will be analysing the responses over the coming months and incorporating your feedback into our policy position going forward. We will also be accepting submissions to our targeted consultation paper on the Priority Review registration process until COB Monday 19 December.
- In the case of Priority Review, medicines could come to market three months sooner and for Provisional Approval, as much as two years sooner than under the current framework.
- These principles will be guide the development of the expedited pathways, both for medicines and medical devices. We need to make sure that the expedited pathways do not unreasonably divert TGA resources from business as usual activities. Specific principles will also be developed for the Provisional Approval pathway.
- NB: in some cases there may be no existing treatment. The MMDR review recommended that entry into the expedited pathways is to be based on transparent eligibility criteria, consistent with those adopted by international regulators, including the FDA, EMA and Health Canada. The proposed criteria have recently been subject to public consultation with consumers, health professionals and industry. This public consultation was open for 6 weeks on the TGA website and closed yesterday, Monday 12 December. We are currently analysing the feedback received on the proposed eligibility criteria. Following public consultation, TGA will develop clear guidance documents detailing the definitions and intended interpretation of key terms used in the criteria. For Priority Review, these activities are currently scheduled for the first half of 2017. Guidance on Provisional Approval will be developed later in 2017.
- The diagram reflects the proposed designation process from our recent public consultation. We are currently analysing the feedback received on this process and therefore it is subject to change. 1. Optional pre-designation meeting Recommended for sponsors intending to apply for designation to an expedited assessment pathway. Similar to the EMA process, it is suggested that the meetings occur 6-7 months prior to submission of the dossier for the registration process. This will provide sponsors with an opportunity to clarify any details relating to their application. It will also give the TGA an early indication of resource and expertise needs for the designation and registration processes. 2. Application Proposed that sponsors will submit an application for designation, providing a rationale as to why the medicine meets the eligibility criteria. Application for designation could be submitted to TGA approximately 10‑12 weeks prior to submission of the dossier. For the Priority Review pathway, it is proposed that sponsors will need to provide evidence of existing Good Manufacturing Practice (GMP) compliance; or show that they have applied to obtain GMP approval for all manufacturing sites and provided the required supporting evidence. 3. Designation decision It is proposed that TGA will have a target timeframe of 20 working days from acceptance and acknowledgement to the sponsor of a complete application to make the designation decision. It is proposed that TGA’s Principal Medical Advisor will be decision maker, in consultation with the relevant TGA clinical delegate. External expert advice We may need to seek external expert advice during the designation process, or early in the evaluation process, in order to make sure we are asking the right questions to aid the expedited process. The expedited pathways will utilise flexible arrangements for seeking external expert advice from the new Advisory Committee for Medicines (ACM) and the specialist expert advisor group being established as part of the MMDR reforms. The relevant TGA advisory committee will be regularly informed of designation decisions for the expedited assessment pathways.
- Options for the publication of designation decisions include: Publication of successful designations and the total number of eligible and ineligible applications, supplemented by a high level statement in annual TGA performance reporting providing details of common reasons why applications were not approved Publication of both successful and un‑successful applications, and key reasons for decisions, on our website at the time of designation Publication of the designation and key reasons for decision in the Australian Public Assessment Reports for prescription medicines (AusPARs), following the conclusion of the registration process For successful applications, noting in the ARTG that these medicines went through Priority Review or Provisional Approval.
- Early clinical data may be based on surrogate endpoints or other relevant data, rather than on patient safety and efficacy data from full Phase III clinical trials. Exit Pathways may be triggered during assessment if an application no longer meets eligibility criteria. We intend to prioritise applications for Provisional Approval in order to facilitate earlier patient access, but we will need to allow sufficient time to ensure that our quality, safety and efficacy standards are not compromised. Assessment of applications via the Provisional Approval pathway may require earlier and more frequent access to expert advice due to their complexity. This may include ad-hoc external expert advice during the designation and evaluation phase, in addition to consideration of the pre-market and post-market aspects by the full ACM. Provisional registration will be limited in duration and will automatically lapse at the end of a specified period unless sponsors meet the conditions imposed by the TGA.
- The Priority Review pathway will be a faster registration process, but will also be resource intensive for both the TGA and sponsors. In order to meet this timeframe, the Priority Review pathway will require new and flexible business processes, and dedicated staff to support this, in order to facilitate faster assessment for registration, while maintaining TGA’s high standards for efficacy, safety and quality. Sponsors will be also need to make a commitment to providing the TGA with all necessary information in a timely manner to be eligible for the designation and remain in the pathway Exit Criteria If sponsors are unable to meet their requirements for Priority Review, the designation may be withdrawn and the submission will be transferred to the standard Prescription Medicines Registration Process. We will develop transparent exit criteria to capture these situations. It is proposed that the exit criteria may be triggered at any time during the registration process. This will ensure that only medicines meeting the intent of Priority Review continue to be assessed in the priority timeframe, therefore reducing the potential impact on BAU.
- Phase 2: receipt of submission It is proposed that submissions under the Priority Review pathway will be in eCTD format. We propose that there will be no batching of applications and the evaluation will commence as soon as dossier validation is complete. Phase 3: first round assessment We propose that the first round assessment will consist of rolling S31 requests without any stop-clocks. Context will be provided alongside questions to assist sponsors with providing responses promptly and to give an early indication of any issues that may be raised by evaluators in their reports. Phase 4: consolidated s31 request The Section 31 request and 30-day stop-clock will only occur if there are outstanding questions and/or it is agreed between the sponsor and TGA. It is proposed that an interim evaluation report will not be sent to the sponsor. Phase 5: second round assessment After responses to questions are received, the evaluation will be completed and the final evaluation report will be finalised and provided to sponsors. It is proposed that the final evaluation report will be provided to sponsors in advance of the Delegate Overview. Sponsors will have at least two weeks after receipt of the final evaluation report to raise any queries before the Delegate Overview is finalised.
- Phase 6: Delegate overview and expert advisory Access to timely expert advice will be important to meet the target timeframe for Priority Review, while ensuring that same standards for efficacy, safety and quality are maintained. Flexible options for obtaining advice include: ad hoc advice from specialist advisors, out-of-session advice provided by the Chair and/or ACM members, and consideration by the full ACM at a routine meeting or out-of-session teleconference. We will need to ensure that our standards for accountability and transparency of TGA decision-making are maintained. Phase 7: Decision It is proposed that the Delegate’s decision will be made within one month, rather than the usual two month period for this phase. Phase 8: Post-decision ARTG entry and AusPARs drafting will be consistent with our usual processes. As part of our public consultation, we will be seeking feedback on whether the ARTG entry and AusPAR should show that medicines were registered through a Priority Review pathway.
- Medicines Regulation The Scientific Evaluation Branch leading 3 of the 5 projects within the medicine regulation stream established to implement the governments response to the Medicines and Medical Device Review: Work-sharing Use of overseas assessment reports and Risk-based variations to registered medicines Work-sharing involves an applicant submitting a registration application for the same medicines to multiple agencies. Agencies work simultaneously to assess different parts of the dossier, with reports provided to decision makers in both countries. The TGA delegate will make a decision on whether to register the medicine based on these assessment reports. Use of overseas assessment reports Involves an applicant to the Australian Government submitting a complete and unredacted assessment report from an overseas regulator together with their application for registration of that medicine. The TGA delegate will make adecision on whether this medicine should be registered in Australia. Risk-based variations to registered medicines Will apply a risk-based approach to the processing of minor variations to registered medicines. In first phase we are implementing a notification process for negligible-risk changes to registered medicines (both prescription and non-prescription).
- Use of overseas reports and work-sharing The pathways for work-sharing and use of overseas reports will involve the TGA identifying comparable overseas regulators. A series of criteria will help identify comparable overseas regulators The first stage involves criteria for identifying the overseas agency as a potential work-sharing partner or as the author of an assessment report. The second stage outlined criteria related to the individual reports received. Consultation on these criteria closed on 12 December. We are reviewing these responses. Over the next year we will be further developing the business processes for work-sharing and use of COR reports. Through work-sharing we hope to encourage applicants to apply for registration in Australia at the same time as in other countries. Through the use of overseas reports, we hope to reduce evaluation times. This will greatly depend on the quality of the individual assessment reports. Both pathways aim to improve the alignment of regulatory requirements between regulators. They will build on TGA’s work long history of international cooperation. Including through the Australia-Canada Regulatory Cooperation Initiative and the International Generic Drug Regulators Programme.
- Variations Currently, all minor variations to registered medicines must be approved, including those known as ‘Self-Assessable Requests’. We will be creating a new notification process where negligible risk changes can be notified to the TGA and then implemented once a fee has been paid. In the first stage, we are implementing negligible-risk changes as notifications. Later we will review other minor variations We have reviewed the initial list of changes proposed as notifications and started targeted discussions with industry bodies. An amendment to the Therapeutic Goods Act to enable notifications was tabled in Parliament recently. Following passage of the bill, we will need to consider changes to the Regulations and legislative instruments. Notifications will be implemented differently for prescription and non-prescription medicines. Over the counter and registered complementary medicines already have an online portal for submission of variations. This portal will be enhanced to enable notifications. For prescription medicines, a new e-form is being built to allow notifications to be submitted to the TGA.