Requirements for RMPs in Australia
•
1 gostou•1,869 visualizações
This presentation provided an introduction to the TGA's requirements for RMPs
Recomendados
Recomendados
Mais conteúdo relacionado
Mais procurados
Mais procurados (20)
Destaque
Destaque (20)
Semelhante a Requirements for RMPs in Australia
Semelhante a Requirements for RMPs in Australia (20)
Mais de TGA Australia
Mais de TGA Australia (20)
Último
Último (20)
Requirements for RMPs in Australia
- 1. Requirements for RMPs in Australia Elspeth Kay Director Risk Management Plan Evaluation Section Pharmacovigilance and Special Access Branch ARCS-TGA risk minimisation workshop, 11 November 2015
- 2. Outline • Workshop goals • TGA’s requirements for RMPs • Why do EU RMPs need to be adapted for Australia? Requirements for RMPs in Australia 1
- 3. Workshop goals • Understand principles for selecting, implementing and evaluating risk minimisation activities • Appreciate range of available risk minimisation activities • Share challenges and approaches Requirements for RMPs in Australia 2
- 4. TGA requirements • TGA follows EMA RMP guidelines • RMP submitted should be the most recent EU- RMP • Core RMP with ASA or Australian RMP acceptable if no EU-RMP exists Requirements for RMPs in Australia 3
- 6. CIOMS IX • Published 2014 • Practical guidance • Contributions from industry, academia and regulatory authorities Requirements for RMPs in Australia 5
- 7. Workflow of a RMP evaluation Risk management plans – an overview 6
- 8. What’s different about Australia? What are the features of our health system, medical practice, geography, population and culture that could influence how risk minimisation tools are selected and implemented? • Indigenous population • Large Asian population • Rurality/lack of access to specialist services • State vs federal control over some aspects of how medicines are used • Access to health professionals and information • …. Requirements for RMPs in Australia 7
- 9. Australian-specific annex • Adapts the EU-RMP to the Australian context: – Not a complete RMP – Summarises certain EU-RMP sections – Similar to country-specific annexes Requirements for RMPs in Australia 8
Notas do Editor
- Background to workshop: following successful March workshop developing/adapting risk min plans identified as a particular challenge for industry – especially evaluation component – so focus today is risk min, not PhV interest in encouraging thinking about local opportunities for risk min activities and evaluation have worked with Deb from ARCS, several industry contributors (partic Minhaj and also Andreas) and with input from ARCS SIG to develop today’s programme grateful to a number of speakers who are presenting to us today – Nicole, Andrew and Andrew from MSIA, James and Yeqin from NPS, David from CSIRO based heavily on CIOMS IX - valuable resource Goals: Brief reminder about TGA’s requirements and the guidelines available to industry, but won’t be setting out rules for what is acceptable and what isn’t – no one right way, each product and RMP considered on case-by-case basis – and there are different ways to get to the same place Discussion of the principles underlying selection, implementation and evaluation of risk minimisation activities (Jane as CIOMS writing group member) Consideration of the reasons why risk min activities may need to be tailored for use in Australia (me, Nicole on ACSOM’s approach) Appreciation for the range of risk min activities (and eval methods) that have been or could be used in Australia (examples presented by industry and sharing experiences in group discussions, and presentations from NPS, MSIA, CSIRO) Opportunity to apply what you’ve heard in hands-on activities RMP team present – introduce them, will be participating in activities and able to provide advice on regulatory process
- RMP guidance and ASA template on TGA website = first port of call When to submit an RMP – and what to do if you’re not sure How to submit an RMP Format to follow Evaluation process for RMPs Post-approval RMP updates TGA has adopted EMA Guideline on good pharmacovigilance practices: Module V – Risk management systems – refer here for structure, content and format of RMP Note that mandatory requirements for an effective application include requirements for EU RMP + ASA [From mandatory requirements]: The risk management plan (if required) is to comply with requirements as set out in TGA guidance: Risk management plans. The Risk Management Plan should be the current, unaltered EU-RMP (if available) and an Australian Specific Annex should be included. An alternative to the EU RMP is acceptable only if there is no current EU-RMP (see Risk management plans). All attachments, annexes and appendices referred to in the RMP should be in English and included in full in electronic form. We will also accept submission of a RMP in the format Guideline on good pharmacovigilance practices: Module V - Risk management systems (EMA/838713/2011, June 2012), with the removal of Part IV of the RMP - Plans for post-authorisation efficacy studies.
- Contact RMP co-ordinator if guidelines don’t answer your questions – and especially if you are uncertain about whether or not your application will require an RMP
- Basis for much of the workshop content Published 2014 Not hard and fast rules, and not an ‘adopted guideline’ Practical guidance Written and contributed to by people from regulatory authorities, industry and academia with expertise in risk management
- [Animated slide of evaluation workflow] Reminder of workflow: 2 rounds of evaluation, s31 questions and response after round 1 ACSOM provides advice to TGA We send selected products, usually First in class NCEs Where we have specific questions about risk min and/or PV approaches Nicole will discuss ACSOM’s approach further Aim to finalise as many issues as possible early in process
- What are features of our culture, medical practice, health system, geography, population that might influence how risk minimisation tools are selected and implemented? eg Smaller market than some other countries (and certainly than all of EU combined – although activities have to be tailored to individual EU member states, many of which are smaller than AU) Adopted EU approach Sources of info used by HPs and consumers: apps, NPS, high use of medical software, CMIs to be provided by pharmacists How we use GPs and specialists PBS vs non-PBS products – impact on usage NMP and well-developed QUM approaches/orgs Availability of other medicines/therapies may be different Emerging use of patient-controlled electronic records Indigenous population Large Asian population Rurality/lack of access to specialist services State vs federal control over some aspects of how medicines are used Australian PI vs EU SmPC Some diseases may be more (or less) prevalent) here Federal system – things under state vs commonwealth control Cost of/access to healthcare – we have relatively low costs and good access – Australians tends to see Dr more often Health professional training? No DTCA Resources/ways in which people access healthcare Involvement of consumer in healthcare decisions – strong consumer movement here
- ASA is used to adapt the EU RMP to Australia ASA almost always required – only time it isn’t is if the RMP you are submitting is completely applicable to Australia (including all proposed PV and RM activities, and identical PI wording) – eg if no EU RMP exists so you provide a core RMP / ‘Australian RMP’. Local documentation (different from EU): - Routine risk minimisation activities (PI/CMI) - Local additional risk minimisation activities e.g. prescriber education - assesses the Australian-specific risks - ties all the local requirements together Template available on TGA website