Reforms to the regulatory framework for listed medicines Dr Cheryl McRae Assistant Secretary, Complementary and OTC Medicines Branch Medicines Regulation Division, TGA Complementary Medicines Australia Innovation Seminar and Expo 2 May 2018
Listed medicines regulatory framework Reforms Implemented already • application timeframes & categories for ingredient evaluations for listed medicines • market exclusivity for new ingredients • list of permitted indications for listed medicines • ‘ Assessed listed’ pre-market evaluation pathway Reforms on the way Use of comparable overseas regulator reports • • Efficacy assessment ‘claimer’ Reforms to come 1 Complementary Medicines Australia Innovation seminar May 2018
Old (pre-reforms) Listed Medicines Regulatory Framework Pre-approved ingredients Good Medicine listed Post-market manufacturing on the ARTG compliance practice (GMP) Pre- approved/self- selected indications 2 Complementary Medicines Australia Innovation seminar May 2018
There are now three pathways for complementary medicines Australian Register of Therapeutic Goods (ARTG) AUST L AUST L(A) AUST R Registered medicines Listed medicines Assessed Listed medicines Pre-market evaluation for: No pre-market evaluation Pre-market evaluation for : • Efficacy – Intermediate (& BUT • Quality permitted) level indications • Pre-approved GMP • Safety • Optional ‘claimer’ • Pre-approved ingredients • Efficacy BUT • Permitted indications • Optional ‘claimer’ ??? • Pre-approved GMP • Pre-approved ingredients Lower risk Higher risk 3 Complementary Medicines Australia Innovation seminar May 2018
Listed medicines - Permitted ingredients AUST L and AUST L(A) can only use permitted • Pre-approved ingredients gredients. in AUST L AUST L(A) • All permitted ingredients and requirements contained in the Permissible Ingredients Determination. Permitted indications • Ingredients database online: www.ebs.tga.gov.au AUST L • If an ingredient is not currently permitted for use in listed medicines, sponsors can apply for the substance to be evaluated. GMP 4 Complementary Medicines Australia Innovation seminar May 2018
Application categories and timeframes for ingredient applications Category Description Screening Evaluation IN1 Evaluation of safety and quality based on evaluation 40 70 reports from CORs. IN2 Evaluation of safety based on evaluation reports 40 120 from CORs Independent evaluation of quality by the TGA. IN3 Evaluation of quality based on evaluation reports 40 150 from CORs; or an accepted monograph. Independent evaluation of safety by the TGA. 40 180 IN4 Full evaluation of safety and quality by the TGA 5 Complementary Medicines Australia Innovation seminar May 2018
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 omplementary medicines. c • 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 6 Complementary Medicines Australia Innovation seminar May 2018
Criteria for comparable overseas regulators • The regulator must be an internationally recognised regulatory authority with an established track record of approving low risk food, chemical or medicinal substances. • The regulator must have a transparent system for regulatory decision-making. • The regulator should have a similar decision-making framework, risk assessment methodologies and legal responsibilities (including confidentiality and impartiality) to the TGA. • The regulator must use internationally accepted scientific standards and guidelines. • The TGA must have, or be able to establish, a relationship with the overseas regulator. 7 Complementary Medicines Australia Innovation seminar May 2018
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. 8 Complementary Medicines Australia Innovation seminar May 2018
When market exclusivity applies • Exclusivity will only be permitted for a new complementary medicine ingredient (active or excipient) that is 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 9 Complementary Medicines Australia Innovation seminar May 2018
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, applications for: A change of permitted use from excipient to an active ingredient a change to the permitted level of use (for example, from 0.5% to 1%) a change to the permitted route of administration (e.g. from topical use to oral use) a change to the permitted use of a herbal ingredient (e.g., a different plant part or preparation method) a change to the requirements to allow use of another strain of a species which is a permitted ingredient (e.g. addition of the LA-5 strain to Lactobacillus acidophilus ) 10 Complementary Medicines Australia Innovation seminar May 2018
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 NEW 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 11
Criteria for Permitted Indications • Permitted indications only refer to: health enhancement e.g. ‘ Promote healthy digestion’ health maintenance e.g. ‘ Maintain healthy joints’ prevention of dietary deficiency e.g. ‘ Prevent dietary calcium deficiency’ a non serious form of a disease or ailment etc . e.g. ‘Relieve Guidelines symptoms of common cold’ on website An exception to these criteria are sunscreen indications and specific indications linked to substance-based restricted representation approvals (folic acid, calcium and vitamin D). 12
Benefits of the list of permitted indications • Greater transparency for consumers and sponsors and what is appropriate for listed medicines. • Avoid consumers from being misled by inappropriate indications and increase consumer confidence in listed medicines. • Reduce the rate of inadvertent sponsor non-compliance. • The TGA now has the capacity to provide accurate statistics on listed medicines e.g. traditional products . 13 Complementary Medicines Australia Innovation seminar May 2018
Summary – Using permitted indications 2. Select core permitted 3 . Select specifying qualifiers indication 1. Select tradition of use (Optional) (Mandatory) (Optional) Sponsors can choose to apply one or more pre- approved qualifiers from a drop down list. At least one core Indications that do not indication is selected in specify a tradition of use ELF using drop down lists are by default scientific. or key word search. Target population Time of use Core permitted indication Specifying qualifiers Tradition of use Healthy target population: ‘in healthy individuals’ ’Relieves muscle aches N/A and pains Time of use: ‘after exercise’ Final permitted indication on the ARTG Relieves muscle aches and pains after exercise in healthy individuals. Complementary Medicines Australia Innovation seminar May 2018 14
Including indications on medicine label • Indications do not have to be included ‘ word for word ’ on your label or advertising material. • However, the intent and meaning of the indication must not change • i.e. the same therapeutic action and target For example: – ARTG indication: ‘Maintain/support gastrointestinal health’ – Label indication - same meaning : ‘Maintains healthy gut’ – Label indication - different meaning : ‘Maintain healthy intestinal flora’ Complementary Medicines Australia Innovation seminar May 2018 15
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