ASMI 2012 Conference: 13 November 2012

Future proofing the consumer healthcare industry

Dr John Skerritt, National Manager

TGA:

the current regulatory reform agenda

The Therapeutic Goods Administration

Regulates therapeutic goods including prescription, over the counter

and complementary medicines, medical devices, blood and blood

products

Evaluates therapeutic goods before they are marketed and monitors

products once they are on the market

Assesses the suitability of medicines and medical devices for export

Focuses on safety, efficacy and quality

Works closely with consumers, health professionals, industry and

international counterparts

Why does TGA regulate OTC and

complementary medicines? Recognition of the role of these medicines for treatment

of self-limiting conditions

To meet consumer expectations that therapeutic products are regulated to ensure standards of quality and safety are met

Recognition that some OTC medicines can have significant adverse effects if used inappropriately

To ensure that indications and claims on labels are evidence-based

To set consistent labelling requirements

TGA’s major priorities in 2012/13

Business as usual - regulation of therapeutic

goods for safety, efficacy and quality

Delivery of reforms outlined in the “Blueprint”

and communicate objectives and timetable

Stronger stakeholder engagement

Regulatory reform

Establishment of ANZTPA

Integration with wider health policy

Released by Parliamentary

Secretary King in December

2011 in response to recent

reviews of TGA

Implementation Plan released

July 2012

Major Blueprint work areas for 2012/13

Communication and stakeholder engagement

Advertising reforms • consider pre-approvals approach, single entry point

• enforce sanctions for breaches

Complementary medicines • levels of evidence required, coded indications

• risk-based approach to post-market reviews

Medical devices

TGA Governance and management

Accelerate organisational change

ANZTPA –joint agency to commence in 2016

Database for Adverse Events Notification launched 1 August 2012

Other Business to Business projects:

• common recalls portal for therapeutic goods and common early warning system

• review and reform business process for evaluation of over-the-counter medicines

• sharing of Good Manufacturing Practice (GMP) reports

Development of a single entry point for industry

Establishment of a common regulatory framework

Development of new “rules” for how ANZTPA will be governed and operate

“Natural Products” in NZ will be outside the scheme

Major effort in policy and legislative development

TGA reforms of

complementary medicines In response to:

- Transparency review

- Informal working group deliberations

- Auditor-General’s report

Planned actions: consultation and communication

Define, adopt and publish consultation principles to guide reform

Develop and implement a comprehensive communication strategy

Improve availability of complementary medicines information from TGA

• provide user-friendly information to consumers about the difference

between listed and registered medicines

• Timely completion of key guidance materials

Improve information available on advertising regulation

• more efficient processing of advertising complaints

• publication of decisions on advertising complaints and investigations

Planned actions: regulation

Improving the integrity of the listing system

limit use of inappropriate claims

• coded indications

• eliminate free text in Electronic Listing Facility

Improve labelling and packaging in consultation with industry

Apply, publicise and enforce penalties for advertising breaches

Enhance sanctions for repeated non-compliance

Listable indications – proposed approach

Should be described as a nominated effect on a target biological

process or clinical condition

Can use either scientific indications or traditional indications

Sponsors required to hold evidence for indications

• scientific indications – efficacy based

• traditional indications – use in a particular paradigm

Health maintenance/ enhancement or management of non-serious

self limiting conditions

Listed medicines must only contain ingredients approved by TGA

Greater transparency of post-market review

and compliance monitoring

TGA to make information available on compliance review selection,

processes and outcomes

Enhancing post-market monitoring

• focus post-market monitoring towards problem areas

• improve post-market review data to inform selection of reviews

Develop and implement standard processes for investigating advertising breaches for complementary medicines

• establish timeframes for the completion of investigations

• identify significant trends in non-compliance

TGA reforms:

OTC medicines

OTC Business process redesign

Deliver more efficient and cost-effective OTC medicine evaluation

Provide greater transparency and predictability of the regulatory

process

Ensure an appropriate benefit/risk model is applied

Harmonise OTC medicine evaluation processes in Australia and NZ

Consultation paper released 17 September 2012

Putting additional resources into reducing application backlog

Proposed approach

Establish risk categories for OTC medicines applications

Define application requirements, business processes, target

times and data requirements for each category

Require applications to be in the common technical document

(CTD) format

Develop OTC medicine monographs for previously-approved

and well-characterised active ingredients

Advertising Therapeutic Goods to consumers

Public consultation on improvements to arrangements for

advertising conducted in 2010

Four areas were identified for further review:

• pre-approval of advertisements – role ?

• Include pay TV and medical devices ?

• complaints handling arrangements – a single entry point within TGA

for receiving all advertising complaints ?

• penalties and sanctions available for advertising breaches

Information paper published in May 2012

Further consultation on policy options currently underway

In conclusion TGA recognises the importance of the OTC medicines industry and

the central role of “informed” self medication in managing demands

on the healthcare system

Regulation relative to the level of risk is critical

TGA commits to improved communication with industry and

consumers, including consulting on proposed reforms

Although complementary and OTC medicines are lower in risk than

prescription medicines, inappropriate promotion and use can: • stop chronically ill people from seeking necessary treatment

• lead to serious side effects for some products, and

• affect TGA’s reputation as a regulator