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

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Risk based regulation of medicines


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Regulatory framework for complementary medicines


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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

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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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Regulatory framework for complementary medicines –

Post-market

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

7

Ongoing monitoring for compliance


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• 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


• 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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• 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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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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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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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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TGA’s role in ensuring quality complementary medicines