This presentation provides an insight into the TGA’s role in ensuring quality complementary medicines.

1. 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

2. 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
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medicines

3. Risk based regulation of medicines
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medicines

4. Regulatory framework for complementary medicines
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medicines
RISK FRAMEWORK

5. 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
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6. 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

7. Regulatory framework for complementary medicines –
Post-market
6http://www.tga.gov.au/about/compliance-framework.htm

8. 7

9. 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

10. 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

11. 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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12. 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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medicines

13. 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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medicines

14. Regulatory framework for complementary
medicines
13TGA’s role in ensuring quality complementary
medicines
RISK FRAMEWORK

15. Regulatory framework for complementary medicines – Post-
market
Post-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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medicines

16. 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

17. 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

18. 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