Update on recent activities Scientific Evaluation Branch Rochelle Christian Assistant Secretary, Scientific Evaluation Branch (SEB) Jenny Burnett Director, Scientific Operations Management, SEB 18 April 2018 Medicines Australia, Regulatory Affairs Working Group
Presentation overview Implemented and ongoing reforms � Variations to prescription medicines - notifications � Comparable Overseas Regulator (COR) reports and work-sharing � Biological and biosimilar medicines naming � Regulation of autologous human cells and tissues � Labelling – half-way through transition period Upcoming reforms � Neuromuscular blocking agents (NMBA) � Faecal Microbiota Transplantation (FMT) � Continual improvement – generic medicines 1
Prescription Medicines Variations e-Form • Launched in mid-2017 • Since then > 2,000 submissions • Changes to manufacturing information – current clearances needed for all nominated manufacturers • Modified December 2017 § New change codes & descriptions added § Allow attachment of supporting data § Updated print preview § Introduction of notifications
Variations to prescription medicines • Phase 1: Notifications for low risk changes to prescription medicines – Launched 4 December 2017 – Must be submitted using the e-form – c. 330 notifications submitted, affecting over 1,000 ARTG entries • Phase 2: Investigating further improvements to our risk-based approach for variations
Comparable Overseas Regulator (COR) report-based process From 2 January 2018 • For prescription medicines with full marketing approval from a COR following a de novo evaluation. • Six overseas regulators identified as CORs. • Unredacted COR evaluation reports must be provided by the applicant. • Two approaches*: – COR-A 120 working days – COR-B 175 working days *depending on extent of TGA evaluation required.
Work-Sharing • Simultaneous evaluation between multiple CORs – Current work with ACSS partners – Joint evaluation report – Independent decision-making – Creation of template documents, alignment between agencies – Early stages
Biological and biosimilar medicines naming • Consultation in 2017 – Improve collection of information on adverse events • Government’s decision – maintain existing convention i.e. continue using the Australian biological name (without a suffix) – mandatory reporting of product's trade name & non-proprietary name, when reporting an adverse event to TGA
Regulation of autologous human cells & tissues • Historically seen as medical practice and outside TGA’s regulatory oversight. • Growing global concern with direct to consumer advertising of unproven autologous stem cell interventions. • Consultation on reforms in 2015 & 2016 • October 2017 government decision announced • Level of regulation (as biologicals) determined by the risk posed to patient safety • Drafting regulatory guidance & amendments to regulations
Labelling Reform New TGO 91 implemented 2016 Four year transition period We are half-way through! All medicine labels must meet new TGO requirements by 2020 8
Key updates to medicine labels • Prominence of active ingredient – Immediately below the name of the medicine. • Name of the medicine – As it appears on the Certificate of Registration. • Schedule 1 – Declarable substances – New requirement for prescription medicines – Includes declarations for substances that are not ingredients. 9
Key updates to medicine labels • Contrasting colours § Required for information on medicine label c.f. background. • Machine readable code § May be used to include information such as batch number & expiry date. • International Harmonisation of Ingredient Names § Australian approved names list, & formulation details for all affected ARTG entries updated with new ingredient names § Transition period for labels & product information until 2020 § Dual-labelled names ‘new name (old name)’ until 2023. 10
We all use medicine labels • Frequent enquiries from consumers & industry – interest level is high! • New webpage for consumers • New webpage for health professionals • Input to newsletters • Social media • Update to labelling guidance published soon 11
Changes to the labelling of Neuromuscular Blocking Agents (NMBAs) • NMBAs are paralysing agents. • Administration errors involving NMBAs § Can cause serious harm § Linked to look-alike labelling & packaging. • Sponsors, healthcare groups & TGA working together to introduce a visual cue § Warning statements § Colour coding. 12
Regulation of donation, manufacture & supply of Faecal Microbiota Transplantation (FMT) material • ‘FMT material’ = donated human stool for application in humans • Increasing attention on use of FMT for treatment of recurrent Clostridium difficile infection • Hospitals & clinics offering FMT material for the treatment of C. diff. & other disorders. • No FMT material is entered as approved goods on ARTG • Access as unapproved goods, e.g. clinical trial, SAS or authorised prescriber • TGA is developing a position paper on regulatory status of current supply. 13
Regulation of donation, manufacture & supply of FMT material FMT material may often meet the definition of a ‘biological’ under Section 32A of the Therapeutic Goods Act: • It comprises, contains or is derived from human cells (e.g. colonocytes) or human tissues. FMT material that is banked: • multiple donations are combined & processed for use in unrelated patients • poses similar risks of infectious disease transmission as for other biological banks, e.g. 14 eye banks.
Regulation of donation, manufacture & supply of FMT material • Biologicals are regulated by the TGA under the regulatory framework for biologicals Safety – different levels of regulation of products based on the risks associated with their use. First! Possible changes for FMT material to address safety concerns: 1. New Standard specific to donor selection & screening for FMT material 2. Transition towards all manufacture of FMT material under GMP (exemption: phase 0 or phase I clinical trials) 3. Information on TGA website to clarify requirements for supply & restrictions to advertising unapproved therapeutic goods 15
Further reforms and improvements - Context Government: Sponsors’ feedback: Industry 4.0: • MMDR reforms – new • Generics take almost as • Changing profile of pathways, shorter timeframes long as NCEs new medicines – more complex • PBS expenditure – more • Milestones important for generics but fewer expensive drugs for smaller predictability overall populations • Appreciate cooperative • Increase in NCEs & • Affordable & sustainable approach to get products biosimilars & shift to health system, especially PBS over the line immunotherapeutics • Patient expectations for early • Focus on material & personalised access to cheaper medicines aspects medicines • Recruitment controls
Recent approval times Category 1 (255 working days) J ul-Dec 2017 J an–J un 2017 J ul-Dec 2016 Application Type Approved M ean Approval Range Approved M ean Approval Range Approved M ean Approval Range Time Time Time New Chemical Entity 22 209 152-245 14 209 177-232 23 200 161-238 Fixed-dose 1 178 178 0 N/A N/A 4 204 179-218 Combination Extension of 21 183 85-223 23 197 106-235 20 199 147-238 Indications Generic medicine 55 190 123-254 59 186 109-254 53 177 124-253 M ajor Variation 21 195 155-254 22 181 139-226 24 195 134-224 PI Change 41 130 7-242 35 143 46-228 30 142 65-212
Approval times - Impact of stop clocks
Continual Improvement – generic medicines Discussions with GBMA & other industry representatives: • Dossier quality – Common issues – Options to address • Options for accelerated review of some generic medicines
Questions? 20
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