Update from the Complementary and OTC Medicines Branch Listed medicines reforms and incentives for innovation Michael Shum Director, Business Improvement and Support Section Complementary and OTC Medicines Branch ARCS Annual Conference: Healthcare 4.0 – the data imperative 21 August 2018
Objectives of the listed medicines reforms Incentivise innovation • To improve the competitiveness of the Australian complementary medicines sector Improve compliance • By strengthening and simplifying the listing system Improve flexibility and predictability • To better support entry of new products to market Improve the evidence base • To give consumer access to a wider range of evidence- based remedies to self-manage their health 1
Reforms to the regulatory framework Reforms implemented already • Permitted indications for listed medicines • Assessed listed pre-market evaluation pathway • 2 year market exclusivity for new ingredients • New application categories and evaluation timeframes for – New ingredient applications – Registered complementary medicine applications 2
Reforms to the regulatory framework Reforms on the way • Efficacy assessment ‘claimer’ • Guidance on use of comparable overseas regulator reports • Enhanced post-market monitoring scheme for listed medicines 3
Overview of complementary medicines regulatory framework Australian Register of Therapeutic Goods (ARTG) Australian Register of Therapeutic Goods (ARTG) AUST L(A) AUST R AUST L Assessed Listed medicines Registered medicines Listed medicines Premarket evaluation for: Premarket evaluation for : No premarket evaluation • Efficacy – Intermediate level • Quality BUT: & permitted indications • Safety • GMP BUT • Efficacy • Pre-approved • GMP AND ingredients • Pre-approved ingredients • Can use ‘claimer’ (Rec 45) • Pre-approved indications AND Can use a ‘claimer’ (Rec 45) Lower risk Higher risk
Listed medicines – standard pathway (AUST L) Permitted indications Permitted ingredients • All permitted indications and their requirements are contained in the Permissible Indications Determination . • New listed (AUST L) medicines can only use permitted Permitted indications. indications • 3 year transition period for sponsors of existing listed medicines. • Sponsors still required to hold evidence of efficacy. GMP • Process and fee for adding new indications. 5
Permitted indications Benefits • Greater transparency for sponsors on what indications are suitable for listed medicines • Avoid consumers from being misled by inappropriate indications and increase consumer confidence in listed medicines • Reduces the rate of inadvertent sponsors non- compliance. Sets a clear boundary between the standard listing and the assessed listed and registration pathways 6
Assessed listed medicine pathway - AUST L(A) • Sponsors self-assess the safety (permitted ingredients) Permitted and quality (pre-approved GMP) of their medicine. ingredients • TGA pre-market assessment of scientific evidence supporting efficacy of the indications in finished product. Intermediate level • Allow higher-level claims (intermediate) which are not therapeutic included on the permitted indications list. indications • Can also include low level indications such as permitted indications. GMP • Option to use an efficacy ‘claimer’. 7
Assessed listed medicine pathway - AUST L(A) 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 that exists for industry between the existing listed and registered medicines pathways. • The claimer would allow products that have had their efficacy assessed to differentiate themselves in the market - marketing advantage. 8
Claimer of efficacy Public consultation on the claimer • We sought feedback on the following: the class or classes of medicines that should be allowed to carry an optional claimer options to implement the claimer as a visual identifier and/or label statement how the claimer can be used on medicine labels. • We also conducted consumer focus group testing on the options presented in the public consultation 9
Claimer of efficacy Next steps • Consideration of the consultation results and analysis • Presentation of the consultation outcomes to the Minister • Publication of consultation outcomes on TGA website 10
Listed medicines - Permitted ingredients • AUST L and AUST L(A) can only use permitted Pre-approved ingredients ingredients. AUST L AUST L(A) • All permitted ingredients and requirements contained in the Permissible Ingredients Permitted Determination. indications AUST L • If an ingredient is not currently permitted for use in listed medicines, sponsors can apply for the substance to be evaluated. GMP • Reforms aim to support entry of new products to market 11
Application categories & timeframes for ingredient applications Category Description Screening Evaluation Evaluation of safety and quality based on evaluation reports 40 70 IN1 from CORs. Evaluation of safety based on evaluation reports from CORs 40 120 IN2 Independent evaluation of quality by the TGA. Evaluation of quality based on evaluation reports from CORs; or an accepted monograph. 40 150 IN3 Independent evaluation of safety by the TGA. Full evaluation of safety and quality by the TGA 40 180 IN4 12
Use of comparable overseas regulators • Where possible, the TGA makes use of assessment from other Regulators for evaluation of a substance for use in listed complementary medicines. • The TGA is continuing to address the Government’s policy of accepting ‘trusted international standards and products’ through implementation of the MMDR reforms. • We are developing: - a list of countries and jurisdictions from whom TGA will accept reports - transparent criteria for and guidance for identifying CORs - a process for using overseas reports 13
Market exclusivity for new ingredients – A successful applicant for a new permitted ingredient may have exclusive use of that ingredient for a 2 year period. – During the specified exclusivity period the use of a protected ingredient in a listed medicine is restricted to: the ingredient applicant other persons nominated by the applicant – At the end of the exclusivity period, the exclusive approval will revert to a general approval and any sponsor can include the ingredient in their listed medicine included in the ARTG. 14
When market exclusivity applies • Exclusivity will only be granted for new ingredients not currently included in the Permissible Ingredients Determination, provided that: - it has not previously been evaluated by the TGA for use in listed or registered medicines - it is not used in, or available for use in registered medicines • It applies to active or excipient ingredients that can be used in listed medicines (complementary medicines, sunscreens and oral health products) We will grant market exclusivity on a first come first service basis 15
When market exclusivity will not apply • Exclusivity will not apply to applications submitted for a new role or a change to any existing requirements for use of a permitted ingredient, for example, changes to: permitted use from excipient to an active ingredient permitted level of use (e.g. from 0.5% to 1%) permitted route of administration (e.g. topical use to oral use) permitted use of a herbal ingredient (e.g. different plant part or preparation) the requirements to allow use of another strain of a species of a permitted ingredient (e.g. addition of the LA-5 strain to Lactobacillus acidophilus ) 16
Find out more https://www.tga.gov.au/assessed-listed-medicines complementary.medicines@health.gov.au
Questions? 18
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