Regulatory updates from the Complementary and OTC Medicines Branch Listed medicines regulatory reforms Michael Shum Director, Business Improvement and Support Section Complementary and OTC Medicines Branch 2019 ARCS Annual Conference 6 August 2019
Objectives of the listed medicines regulatory reforms Industry Consumers Simplify the listing Improve system compliance Improve flexibility Improve the and predictability evidence base Incentivise Transparency innovation about evidence Regulatory updates from the Complementary and OTC Medicines Branch
Staged implementation • Online catalogue of permitted ingredients • Review and appeal rights for ingredient applicants 2017 • Permitted indications for listed medicines • Assessed listed pre-market evaluation pathway 2018 • 2 year market exclusivity for new ingredients • Legislated evaluation timeframes • ‘TGA assessed’ claim 2019 • Risk-based approach to listed medicine variation s Regulatory updates from the Complementary and OTC Medicines Branch
Overview of complementary medicines regulatory framework Australian Register of Therapeutic Goods (ARTG ) AUST R AUST L AUST L(A) Registered medicines Assessed Listed medicines Listed medicines Premarket evaluation for Premarket evaluation for : NO premarket evaluation efficacy only • GMP BUT must have: (Intermediate level & permitted • Quality • GMP indications) • Safety • Permitted ingredients BUT must have • Efficacy • Permitted indications • GMP AND can have • Permitted ingredients • TGA assessed claim AND can have • TGA assessed claim Lower risk Higher risk Regulatory updates from the Complementary and OTC Medicines Branch
Permitted indications: Reality of implementation 4 Regulatory updates from the Complementary and OTC Medicines Branch
What do permitted indications mean for sponsors? • Sponsors listing a medicine on the ARTG are only able to use indications from a list of permitted indications • “ Free text ” field is no longer available • Sponsors must continue to hold supporting evidence for their medicine indications • There must not be inconsistency between the indications that are listed in the Register and on the label • 3 year transition period for existing listed medicines 5 Regulatory updates from the Complementary and OTC Medicines Branch
Transition arrangements – key dates • All new listed medicines must select permitted indications • Sponsors of medicines listed in the ARTG before 6 March 2018 must re-list their medicine using ‘permitted indications’ by 6 March 2021 • Products that have not transitioned by 6 March 2021 will be cancelled from the ARTG. Changes made before 6 September 2019 can be done free of charge Regulatory updates from the Complementary and OTC Medicines Branch
Permitted indications Benefits • Greater transparency for sponsors on what indications are suitable for listed medicines • Avoids consumers being misled by inappropriate indications • Reduces the rate of inadvertent sponsors non- compliance • Sets a clear boundary between the standard listing and the assessed listed and registration pathways Regulatory updates from the Complementary and OTC Medicines Branch
Challenges The list is too long! ‘The TGA is endorsing pseudo science!!!’ Consumers The list is too short! A comprehensive list of • Restricted indications suitable for representations listed medicines • Biomarkers etc.. ? Industry TGA Regulatory updates from the Complementary and OTC Medicines Branch
Transition summary 10319 listed medicines in the ARTG – 4629 using permitted indications (~45%) – 5693 with ‘standard’ or specific indications Permitted indications commenced 6 March 2018 Regulatory updates from the Complementary and OTC Medicines Branch
Nothing is perfect … Updates to the list of permitted indications since implementation • New indications • Clarity and consistency in requirements • New requirements • Correct errors/omissions Feedback welcome! Regulatory updates from the Complementary and OTC Medicines Branch 10
Questions from industry Additional guidance/clarification • When do I need to use evidence qualifiers? • What evidence do I need if my indications aren’t qualified? • How can I combine indications on my medicine labels? • How can pregnancy indications be used? See FAQs on issues raised by industry in relation to permitted indications 11 Regulatory updates from the Complementary and OTC Medicines Branch
Questions from industry Use in advertising • Am I compliant with the advertising code? Application requirements for new indications • What evidence is required for applications for new indications? Re-listing process • How do I do it? • ELF is……slow 12 Regulatory updates from the Complementary and OTC Medicines Branch
Our advice … • Follow the Permitted indications for listed medicines guidance – Keep it simple when modifying or combining indications – Use the indication qualifiers from the drop down lists in ELF • Start preparing to transition early - you may need to make other changes (e.g. update GMP) 13 Regulatory updates from the Complementary and OTC Medicines Branch
Assessed listed medicines pathway: Reality of implementation 14 Regulatory updates from the Complementary and OTC Medicines Branch
Assessed listed medicine pathway • Sponsors self-assess the safety (permitted ingredients) and quality (pre-approved GMP) of their medicine • TGA pre-market assessment of scientific evidence supporting efficacy for the proposed indications • Allow higher-level claims which are not included on the permitted indications list (eg restricted representations) Regulatory updates from the Complementary and OTC Medicines Branch
Assessed listed medicine pathway Benefits • Access to higher level indications than those on the list of permitted indications • Encourages industry to improve the standard of evidence for listed medicines • Bridges the gap between the existing listed and registered medicines pathways Marketing advantage through use of the ‘TGA assessed’ claim Regulatory updates from the Complementary and OTC Medicines Branch
Challenges Flexibility for industry Evidence standards Suitable Consumer confidence indications Regulatory updates from the Complementary and OTC Medicines Branch
Feedback from pre-submission meetings Common discussion points • Low vs intermediate vs high level indications • Suitability of suggested indication vs clinical trial design/evidence: ⁻ e.g. dosing on proposed label vs clinical trial ⁻ e.g. proposed formulation vs clinical trial formula - what can be changed? • Dossier requirements 18 Regulatory updates from the Complementary and OTC Medicines Branch
Our advice … • Request a pre-submission meeting • Identify appropriate indications • Take care when putting your dossier together – there are mandatory requirements 19 Regulatory updates from the Complementary and OTC Medicines Branch
‘TGA assessed’ claim 20 Regulatory updates from the Complementary and OTC Medicines Branch
TGA assessed claim • Sponsors of assessed listed medicines and registered complementary medicines have the option to use ‘TGA assessed’ claim’ • Indicates that the efficacy of the product has been assessed for the approved indications by the TGA • The medicine label is required to be approved by the TGA before marketing • There is an approved symbol and approved label statement 21 Regulatory updates from the Complementary and OTC Medicines Branch
TGA assessed claim Benefits • Support consumers to make informed purchasing decisions • Improve consumer awareness about medicines regulation • Incentive for product sponsors to improve the standards of evidence for complementary medicines Regulatory updates from the Complementary and OTC Medicines Branch
TGA assessed claim – consumer insights Design considerations • Use simple language (e.g. avoid ‘efficacy’) • Refer to the Government to build trust • A symbol is more recognisable than a statement Regulatory updates from the Complementary and OTC Medicines Branch
TGA assessed claim – consumer insights Unsure about • Who the TGA is • How we regulate • What we have assessed BUT • Likely to be a positive influence on purchasing decisions Regulatory updates from the Complementary and OTC Medicines Branch
Access to the TGA assessed claim • Contact the TGA for the symbol file at complementary.medicines@health.gov.au. • Guidance on the process and requirements now available: – Location – Text size – Font style and colour – Use in advertising 25 Regulatory updates from the Complementary and OTC Medicines Branch
Coming soon…. • Changes to the Advertising Code to allow use for registered complementary medicines • Instrument of approval Regulatory updates from the Complementary and OTC Medicines Branch
Coming soon… • Support understanding of the TGA assessed claim and the TGA: – Education for pharmacists and pharmacy assistants – Simpler resources for use by consumers – Improve the usability and information provided on the TGA website for consumers Regulatory updates from the Complementary and OTC Medicines Branch
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