Update from the Complementary and OTC Medicines Branch Listed - - PowerPoint PPT Presentation

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

• To improve the competitiveness of the Australian

complementary medicines sector

Incentivise innovation

• By strengthening and simplifying the listing system

Improve compliance

• To better support entry of new products to market

Improve flexibility and predictability

• To give consumer access to a wider range of evidence-

based remedies to self-manage their health

Improve the evidence base

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 Listed medicines

No premarket evaluation BUT:

• GMP
• Pre-approved

ingredients

• Pre-approved indications

AUST L(A) Assessed Listed medicines

Premarket evaluation for:

• Efficacy – Intermediate level

& permitted indications BUT

• GMP
• Pre-approved ingredients

AND Can use a ‘claimer’ (Rec 45)

AUST R Registered medicines

Premarket evaluation for:

• Quality
• Safety
• Efficacy

AND

• Can use ‘claimer’ (Rec 45)

Lower risk Higher risk

Listed medicines – standard pathway (AUST L)

Permitted ingredients Permitted indications GMP

Permitted indications

• All permitted indications and their requirements are

contained in the Permissible Indications Determination.

• New listed (AUST L) medicines can only use permitted

indications.

• 3 year transition period for sponsors of existing listed

medicines.

• Sponsors still required to hold evidence of efficacy.
• 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)

Permitted ingredients Intermediate level therapeutic indications GMP

• Sponsors self-assess the safety (permitted ingredients)

and quality (pre-approved GMP) of their medicine.

• TGA pre-market assessment of scientific evidence

supporting efficacy of the indications in finished product.

• Allow higher-level claims (intermediate) which are not

included on the permitted indications list.

• Can also include low level indications such as permitted

indications.

• 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

Pre-approved ingredients

AUST L AUST L(A)

Permitted indications AUST L GMP

• AUST L and AUST L(A) can only use permitted

ingredients.

• All permitted ingredients and requirements

contained in the Permissible Ingredients Determination.

• If an ingredient is not currently permitted for use

in listed medicines, sponsors can apply for the substance to be evaluated.

• Reforms aim to support entry of new products to

market

11

Application categories & timeframes for ingredient applications

Category Description Screening Evaluation IN1 Evaluation of safety and quality based on evaluation reports from CORs. 40 70 IN2 Evaluation of safety based on evaluation reports from CORs Independent evaluation of quality by the TGA. 40 120 IN3 Evaluation of quality based on evaluation reports from CORs; or an accepted monograph. Independent evaluation of safety by the TGA. 40 150 IN4 Full evaluation of safety and quality by the TGA 40 180

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