TGA’s role in ensuring quality complementary medicines

TGA’s role in ensuring quality complementary medicines

3 June 2015

Larry Kelly

First Assistant Secretary

Monitoring and Compliance Division, TGA

Complementary Medicines Australia - 2015 Quality Learning Seminar

TGA’s role – part of the Commonwealth Department of Health

• Regulates therapeutic goods including prescription, over-the-counter and complementary

medicines, medical devices, biologicals, blood and blood products

• Applies risk-based practices in pre- and post-market phases

• Focuses on safety, efficacy and quality

• We do not make regulatory decisions based on cost or value for money

1TGA’s role in ensuring quality complementary

medicines

Risk based regulation of medicines

2TGA’s role in ensuring quality complementary

medicines

Regulatory framework for complementary medicines

3TGA’s role in ensuring quality complementary

medicines

RISK FRAMEWORK

Regulatory framework for complementary

medicines – Pre-market• Listed complementary medicines are included in the Australian Register of Therapeutic Goods

(ARTG) via an electronic lodgement process

• Products must be made from a list of ‘safe’ ingredients, with limits on quantities where relevant,

and must not make high-level claims

• Must be made in TGA approved manufacturing facilities

TGA’s role in ensuring quality complementary

medicines

4

Regulatory framework for complementary

medicines – Pre-market• No requirement for sponsor to provide efficacy data prior to lodgement but must certify that efficacy data is

available on request

• Sponsor certifies the information in the application is true and correct

• TGA undertakes random and targeted desk top compliance audits of listed complementary medicines

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medicines

Regulatory framework for complementary medicines –

Post-market

6http://www.tga.gov.au/about/compliance-framework.htm

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Ongoing monitoring for compliance

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medicines

• Ongoing monitoring detects signals of potential

safety or compliance issues

• Signals are triaged

• Compliance action taken where appropriate

• Monitoring programs may be adjusted as a

result

Ongoing monitoring for compliance

• We use a series of ongoing monitoring activities to ensure that regulatory compliance and safety of products

continues after supply

– sponsors are responsible for the performance of their products in the marketplace, and

– sponsors must report serious problems to the TGA in a timely manner

• We monitor the market for signals of potential non-compliance

• A risk-based approach is used to determine the significance of signals and the appropriate regulatory

response

• We apply a proportionate response to non-compliance

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medicines

Ongoing monitoring for compliance

• Monitoring activities may include:

– random, flagged or targeted reviews of technical and/or clinical information

– laboratory testing for compliance with standards (BP, USP etc)

– inspections of manufacturer’s or sponsor’s records and documentation

– audits of distribution records

– audits of the traceability of raw materials used in the manufacture of therapeutic goods

– trend analysis (refer to http://www.tga.gov.au/about/tga-performance-report.htm)

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Compliance action

• We may take corrective action if problems are found, such as:

– sponsors and/or manufacturers not fulfilling their regulatory responsibilities

– Products found to be of unacceptable safety, quality or efficacy

– certifications made in an application are incorrect or no longer correct

• Actions may be batch specific or may be at product level

• Main drivers for regulatory action:

– Public health impact

– Repeat offenders

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Compliance action

• We can take a range of action in relation to a compliance matter:

– encouragement/guidance

– warnings

– Imposition of conditions on ARTG entry or manufacturing licence

– Suspension or cancellation of ARTG entry or manufacturing licence

– criminal prosecution/civil penalties

– product recall

– seizure and destruction of unlawful product

• We work with sponsors to achieve compliance where possible

• Details of compliance actions and product recalls are published on our website

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Regulatory framework for complementary

medicines

13TGA’s role in ensuring quality complementary

medicines

RISK FRAMEWORK

Regulatory framework for complementary medicines – Post-

marketPost-listing activities include:

• desk-based audits of listed medicines

• laboratory testing of products and ingredients for compliance with standards

• surveillance in the marketplace

• monitoring of adverse reactions

• audit of manufacturing sites

• controls for advertising

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Regulatory framework for complementary medicines – Post-

market

• Ingredients and Products must comply with BP/EP or USP where a monograph exists

• TGA testing is for compliance with these requirements

• A very small number of complementary medicines are covered by Official monographs

• We also test for the presence of adulterants

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medicines

Regulatory framework for complementary medicines -

Manufacturing guidance

• TGA requires compliance with the PIC/s Code of Good Manufacturing Practice for Medicinal

Substances

• With industry, TGA has developed interpretive guidelines for the particular requirements of

complementary medicines on:

– Supplier qualification

– Stability testing

– Product Quality Reviews

– Sampling and testing

– Process validation

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medicines

In conclusion, the key features of the TGA regulatory framework are:

• A risk-based approach is taken to regulation, with different levels of risks for different products.

• Regulation occurs both pre-market and post-market but for listed medicines most regulation is post-market

• Both product risks and compliance risks are regulated.

• There is a focus on fostering voluntary compliance

• Regulatory responses are proportional to the risks to public health

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medicines