We think you have liked this presentation. If you wish to download it, please recommend it to your friends in any social system. Share buttons are a little bit lower. Thank you!
Presentation is loading. Please wait.
Published byBrad Hocking
Modified over 2 years ago
© Crown copyright 2005 Safeguarding public health Review of Unlicensed Medicines MHRA meetings with interested parties March 2011
Title: RUM progress report © Crown copyright 2005 Purpose of meeting To explore with interested parties latest thinking on ideas on reform developed by the RUM Steering Group Reflects responses to earlier consultation; also our understanding of the Coalition’s regulatory agenda Aim is to test out current thinking before revising and/or firming up proposals for formal consultation later in 2011 Looking for help in teasing out regulatory impact Health Warning! Specific ideas for reform presented are ideas for exploration and don’t necessarily represent official policy of MHRA or any others represented on RUM Steering Group
Title: RUM progress report © Crown copyright 2005 Review of unlicensed medicines Remit: Review UK use of the derogation permitted in Art 5.1 of Directive 2001/83/EC Coverage: UK “Specials” and associated import notification scheme RUM Steering Group: MHRA, Health Departments, NPSA, PASA Timetable 2007 Review set up: Feb 2008 Concept paper May 2009 Interim Report Late 2009 / early 2010 updating proposal in light of responses to consultation Late 2010 to date – update in light of Coalition’s regulatory agenda
Title: RUM progress report © Crown copyright 2005 Aims Prescribers able to take professional responsibility to supply unlicensed medicines to meet special needs Improve public health protection Clear responsibility/accountability for protecting patient safety and rights Meet Better Regulation principles: proportionality, targeting, consistency, transparency and accountability Arrangements to complement not undermine licensing of medicines
Title: RUM progress report © Crown copyright 2005 Where are we now? Proposals largely unchanged from earlier consultation Quality and manufacturing standards applying to Specials Strengthen pharmacovigilance Advertising Proposals changed since last consultation Patient information -Greater responsibility on healthcare professional to exercise judgement Proposal for structural reform of notification system covering both domestic manufacture and imports -Ideas for improved streamlining
Title: RUM progress report © Crown copyright 2005 Proposals largely unchanged………
Title: RUM progress report © Crown copyright 2005 Quality & Manufacturing Feedback Support for quality standards Support for development of BP monographs Some concerns about application of standards to low volume products; impact on small manufacturers Proposed approach Develop further guidance on application of GMP to these products Continue programme of developing BP monographs for unlicensed medicines
Title: RUM progress report © Crown copyright 2005 BP Monographs for Unlicensed Medicines The publication of a BP monograph provided a legally binding enforceable quality standard for unlicensed medicines Unlicensed Medicines in the BP -Supplementary chapter (non-mandatory) -General monograph (compliance mandatory) -Product monographs (compliance mandatory)
Title: RUM progress report © Crown copyright 2005 Supplementary Chapters Chapter V Introduction Legal requirements Ethical consideration and guidance Labelling Standards for preparation and manufacture Chapter V.a Preservative-free unlicensed medicines Chapter V.b Bioequivalence of oral suspension Chapter V.c (Draft for 2011 edition) Storage and shelf lives for unlicensed medicines Chapter V.d (Draft for 2011 edition) Formulations for Extemporaneous Preparations
Title: RUM progress report © Crown copyright 2005 General Monograph for Unlicensed Medicines Definitions Scope Production Labelling requirements Requirements for Formulated Preparations
Title: RUM progress report © Crown copyright 2005 Published Monographs for Unlicensed Medicines 2008 Caffeine citrate injection Caffeine citrate oral solution Dantrolene oral suspension Levomenthol cream Mercaptopurine oral suspension Paediatric phenobarbital oral solution Potassium chloride oral solution Sodium chloride oral solution Sodium fluoride oral solution
Title: RUM progress report © Crown copyright 2005 Published Monographs for Unlicensed Medicines 2009 Adrenaline and cocaine intranasal solution Captopril oral solution Cocaine paste Compound glucose, sodium chloride and sodium citrate oral solution Hydrocortisone sodium phosphate oral solution Potassium dihydrogen phosphate oral solution Vancomycin oral solution
Title: RUM progress report © Crown copyright 2005 Published Monographs for Unlicensed Medicines 2010 Allopurinol oral suspension Bapivacaine and fentanyl injection Chloral hydrate oral solution Magnesium glycerophosphate oral solution Midazolam oral solution Phosphate oral solution Propylene glycol solution Warfarin oral suspension
Title: RUM progress report © Crown copyright 2005 Work programme for monographs for Unlicensed Medicines 2011 Bupivacaine and diamorphine injection Clozapine oral suspension Dinoprostone oral solution Coal tar paste Coal tar and salicylic acid ointment Salicylic acid cream Salicylic acid ointment Silver nitrate solution Sodium chloride nebuliser solution Sodium carbonate oral solution Cefuroxime eye drops Disodium edetate eye drops
Title: RUM progress report © Crown copyright 2005 Pharmacovigilance – Proposals Introduction Pharmacovigilance (PhV) is a key activity in ensuring the safety of all medicinal products throughout their lifecycle. A significant element of effective PhV is the reporting and analysis of suspected adverse drug reactions (ADRs). Proposals Duty on UK manufacturers and importers to communicate to the MHRA all suspected (ADRs) – not just serious ADRs. Promote reporting of suspected ADRs by healthcare professionals and patients via the Yellow Card system.
Title: RUM progress report © Crown copyright 2005 Pharmacovigilance – The Future Consultation General support for strengthened PhV. Positive response to promoting Yellow Card reporting via patient and healthcare professional information. Concern regarding complexity and cost. Solutions Practical system – electronic reporting. Simplicity – report all suspected ADRs. Realistic timelines. Use patient and healthcare professional information to encourage Yellow Card reporting.
Title: RUM progress report © Crown copyright 2005 Advertising ■ It would be permissible to circulate simple price lists to potential healthcare professional customers in response to an enquiry provided no product claims are made. ■ It would be acceptable to promote the service offered.
Title: RUM progress report © Crown copyright 2005 Proposals developed further since last consultation…..
Title: RUM progress report © Crown copyright 2005 Patient Information Object of reform -Patient information requirements should be strengthened Options going forward -General support in the consultation for information with unlicensed medicines -No requirement for information in every case -BUT professional guidance will cover this
Title: RUM progress report © Crown copyright 2005 Labelling Object of reform - Labelling requirements should be strengthened Options going forward -Generally support in the consultation for standard labelling -Labelling should be in English -Labelling requirements should follow those set out in the British Pharmacopoeia and MHRA Guidance Note 25
© Crown copyright 2005 Safeguarding public health RUM: Structural Reform “option 8”
Title: RUM progress report © Crown copyright 2005 Requirements Must apply equally to importers and manufacturers Must have minimum possible regulatory impact Must provide regulatory oversight of key safety issues
Title: RUM progress report © Crown copyright 2005 Principles MHRA wishes to know about only products/activities: That raise safety concerns That may not meet special clinical need requirements
Title: RUM progress report © Crown copyright 2005 Previous Proposals Considered feedback Current Government policies -Together suggest previous proposals too complex (“option 7”) -New proposals developed (“option 8”)
Title: RUM progress report © Crown copyright 2005 Option 8 Manufacture/import of unlicensed medicines may be performed with minimal regulation (i.e. no notifications needed) for licence holders unless: -Change of category on master licence is required for manufacturers (MS) ·Variation for new categories -Item is on a “Restricted List” ·Variation required to permit import/manufacture Real-time feedback of changes via Risk Based Inspection (RBI) programme
Title: RUM progress report © Crown copyright 2005 Master Licences – activities Currently the MS has a range of categories of activities specified -Requires rationalising -May need some new categories/sub-categories Categories may be added by means of variation MHRA will conduct survey to assist rationalisation -Probably no fee for resulting updates
Title: RUM progress report © Crown copyright 2005 Restricted List - products A licence holder must apply for their licence to be varied for items on this list to be added to their licence Application similar to current import notification (28 days etc.). Granted variation will have appropriate validity period Provision for urgent applications (incl. Out-of-hours) Assessment against risk and compliance with licence Fee per variation. New variation required on expiry Additional fee for referral to Expert Committee
Title: RUM progress report © Crown copyright 2005 Example Restricted List Products with the same drug substance and pharmaceutical form as products with EU or UK national licences, except where prepared from these licensed products, or from another “notified” unlicensed product. Public listings of licensed products can be made available Products from outside the EEA Imported products not licensed in the country of origin Specific products with safety concerns
Title: RUM progress report © Crown copyright 2005 Notifications under RBI Programme – MS holders Changes within existing licence categories to be notified via Inspectorate -Where new API used for manufacture of a product from raw materials (i.e. not from another product) ·- aims to capture “unknowns” -Could exclude unlicensed products with BP Monographs ·(but these could still appear on Restricted List) -Could also publish guidance giving acceptable APIs to limit number of notifications required
Title: RUM progress report © Crown copyright 2005 Decision Tree
Title: RUM progress report © Crown copyright 2005 Preliminary Impact Assessment “ Back of envelope” estimate of volumes Review of import notifications and of sample product lists from large specials manufacturers The total numbers falling within the restricted list was less for manufacturers than importers by a factor of approximately 1:5 -many products are prepared from existing licensed products and are thus not in the Restricted List Currently, the total number of notifications per annum from importers is ~75,000 ~10% of this is expected under Option 8 from importers. If manufacturers notify ~20% of this, a total of ~10,000 submissions per annum might be expected under Option 8
Title: RUM progress report © Crown copyright 2005 English Language Labelling MHRA is aware that these will impact particularly on importers Comments invited
Title: RUM progress report © Crown copyright 2005 Transitional Arrangements Under consideration: Variation applications during introductory year -Used to gather data and set baseline for licence holders -No fees in this period -Major issues only for regulatory action
Title: RUM progress report © Crown copyright 2005 Discussion….. Feedback welcome …..
© Safeguarding public health Expert Group on Innovation in the Regulation of Healthcare products Adaptive Licencing workshop at the Wellcome Trust October.
Implementation of EU Electronic Communication Directives.
Main Requirements on Different Stages of the Licensing Process for New Nuclear Facilities Module 4.1 Steps in the Licensing Process Geoff Vaughan University.
December 2005 EuP Directive : A Framework for setting eco-design requirements for energy-using products European Commission.
Public Consultation Session: Consultation and Transparency Requirements for Offshore Petroleum Activities Francesca Astolfi A/g General Manager, Offshore.
WHO Good Distribution Practices for Pharmaceutical Products
New Zealand Medicines and Medical Devices Safety Authority A business unit of the Ministry of Health.
Chapter 18 Internal Auditing and Outsourcing. Define Internal Auditing Internal auditing is an independent and objective assurance and consulting activity.
The Herbal Medicines Advisory Committee (HMAC) Alison Denham FNIMH EHTPA Regulation Conference 12 May 2007.
Objectives Why we need DHCPL Situations that call for a DHCPL Definitions DHCPL itself–content, presentation, process Target audience Current and future.
Health and Safety Executive Health and Safety Executive Competent Authority & Data Reporting HSE/DECC Consultation Events - Spring 2014 EU Offshore Directive.
SEN and Disability Green Paper Update on draft legislation and pathfinder programme.
Stakeholders In Clinical Research Government and Regulatory Bodies Professor Phil Warner.
An agency of the European Union Presented by: Emer Cooke and Truus Janse-de Hoog Update on Transparency Progress report from HMA/EMA TF on Transparency.
The Changing Face of EU Legislation Is the EU moving towards the FDA model of pharmaceutical legislation? By Robert Smith Director.
PharmacoVigilance: Development of PhV systems and processes.
Helping the people of Canada maintain and improve their health Aider les Canadiens et les Canadiennes à maintenir et à améliorer leur état de santé Path.
The Aarhus & Espoo Conventions Making implementation work for stakeholders.
IPhVWP Polish Presidency, Warsaw October 6 th 2011 Almath Spooner Irish Medicines Board Monitoring the outcome of risk minimisation activities.
Registering the care sector – next steps Dr Linda Hutchinson Director, Care Quality Commission National Care Association Conference, 21 October 2010.
Regulation of Low Level Waste Management
Spectrum authorisation under new EU package Roger Stewart Radiocommunications Agency Head of licensing policy unit.
PharmacoVigilance: Development of PhV systems and processes VICH Workshop, Dar Es Salaam, Tanzania, 24 June 2015.
Drug Submissions: Review Process Agnes V. Klein, MD Biologics and Genetic Therapies Directorate February, 2003 www/hc-sc.gc.ca/hpb-dgps/therapeut.
Consolidation and Review of Financial Services Legislation (“ CAROL ”) Jane D N Bates Head of Policy and Legal Unit Financial Supervision Commission 21.
1 Welcome Safety Regulatory Function Handbook April 2006.
Armand Racine Consultant Chemicals Branch
EPAA Conference 5 November 2007 Georgette LALIS Enterprise and Industry DG European Commission The international dimension of regulatory acceptance.
Adult HIV Outpatient PBR Tariff Development National Reference Group Meeting 21/05/10.
Drug Promotion And Dealing With The ‘Reps’ Neena Lakhani.
Portfolio Committee for Health Medicines and Related Substances Amendment Bill (06/08/08) IMSA represents Research Based Pharmaceutical Companies.
Overview of Risk management: A EU perspective Lincoln Tsang May 2008.
Revalidation and Code review update November 2014.
Helping to make care better Cynthia Bower, CEO National Care Association Conference 11 November 2009.
THE GAMBLING ACT 2005 Training Pack. Department for Culture, Media and Sport Improving the quality of life for all The Gambling Act 2005 The Gambling.
Registration Speaker Susan Robinson Job Title Area Manager
Regulators’ response to consultation on EU legislative proposals for pharmacovigilance : common themes 2 nd International Pharmaceutical Regulatory and.
Good Clinical Practice in Research Clinical Trial Regulations
ROLE OF THE PHYSICIAN IN THE APPROVAL PROCESS Stephanie de Bono MD PhD Medical Advisor, Eli Lilly.
Extending Professional Regulation Presentation to Association of Advanced Nursing Practice Educators 27 February 2009.
A Day in the Life 2014 “Licensing Made Easy” TIM SHIELD.
European Commission Rita L’ABBATE Legal aspects linked to internal market DG Enterprise and Industry MARKET SURVEILLANCE COMMUNITY FRAMEWORK UNECE “MARS”
WHO COURSE FOR THE CARs MONITORING AND AUDITING OF FOOD LAW COMPLIANCE AND ENFORCEMENT.
E-SICK LEAVE ATTESTATION Medical Committees Section.
Selection of essential medicines Richard Laing and Deidre Dimancesco TBS 2011 Department of Essential Medicines & Pharmaceutical Policies TBS 2008.
How is CQC ensuring safe, high quality and best value services during challenging times? Alan Rosenbach Special Policy Lead, CQC 7 th March 2011.
The New(ish) European Pharmacovigilance Legislation Jacquelyn Awigena-Cook Associate Director, Head PV Policy ISCT Satellite GRP Workshop 27 January 2013.
1 PHARMACOVIGILANCE & THE NATIONAL ADVERSE DRUG REACTION (ADR) REPORTING SYSTEM Sarah Spiteri Post-Licensing Directorate Medicines Authority.
© Crown copyright 2005 Safeguarding public health The 2001 Review and its Impact upon Excipient Suppliers Richard Andrews Operations Manager GMP.
Recommendation 2001/331/EC: Review and relation to sectoral inspection requirements Miroslav Angelov European Commission DG Environment, Unit A 1 Enforcement,
© 2017 SlidePlayer.com Inc. All rights reserved.