You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Presentation: How do listed medicines shape up in the post-market compliance space?

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

15 August 2016

Disclaimer

These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Dr Allison Jones
  • Presented at: ARCS Scientific Congress Canberra
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation provides an overview of the TGA's post-market compliance program and how data from the program is used to manage non-compliance and highlight areas of concern.

Transcript

How do listed medicines shape up in the post-market compliance space?

An update from the Complementary and Over-the-counter Medicines Branch of the TGA

Dr Allison Jones
Director
Listing Compliance, Complementary and Over-the-counter Medicines Branch
Health Products Regulation Group, TGA

ARCS Scientific Congress, 10-11 August 2016

Slide 1 - Overview

  • What is our post-market compliance program?
  • 2015-16 Compliance data
  • Breaking down the data
  • Compliance projects
  • Our goals
  • What's in store for the future

Slide 2 - What is our post-market compliance program?

  • Random reviews
  • Targeted reviews
  • Investigations (complaints and referrals)
  • Project work
  • Business improvement

Slide 3 - 2015-16 Compliance data

Investigations and outcomes

60% of all investigations became targeted reviews

2014-15
Jul-Jun
2015-16
Jul-Jun
Initiated investigations 86 114
Complete investigations
Medicines prioritised for targeted review 24[a] 69
Referred to another TGA area or government organisation 5[a] 14
No further action taken 24[a] 32
Total completed investigations 99 115
  1. Data collection commenced Jan 2015.

Slide 4 - 2015-16 Compliance data

Reviews by type

80% of all reviews had verified compliance breaches

2014-15
Jul-Jun
2015-16
Jul-Jun
Initiated reviews
Targeted reviews 41 173
Random reviews 89 340
Total 130 513
Reviews on hand 188 151
Complete reviews
Targeted reviews 153 158
Random reviews 56 315
Total 212 473

Random up by 560%

Total up by 220%

Slide 5 - Outcomes of completed reviews

outcomes of completed reviews

Random

  • Compliant, 74, 28%
  • Cancelled by TGA after P2C, 15, 5%
  • Cancelled by sponsor request after P2C, 29, 11%
  • Compliant after P2C, 148, 56%

Targeted

  • Compliant, 7, 5%
  • Cancelled by TGA after P2C, 29, 20%
  • Cancelled by sponsor request after P2C, 59, 42%
  • Compliant after P2C, 47, 33%

Slide 6 - Breaking down the data

Types of non-compliance identified

Biggest issues account for ~80% of non-compliance:

  • Labelling
  • Advertising
  • Evidence

breaking down the data random reviews and targeted reviews

Random Reviews

  • ARTG info 9%
  • Quality 9%
  • Labelling advertising 40%
  • Evidence 41%
  • Safety 0%
  • Other 1%

Targeted Reviews

  • ARTG info 11%
  • Quality 15%
  • Labelling advertising 36%
  • Evidence 31%
  • Safety 6%
  • Other 1%

Slide 7 - Breaking down the data

Evidence issues in more detail (based on last half of 2015)

  • Highlights
    • Biomarkers
      • Blood glucose
      • Cholesterol
    • Arthritis

Slide 8 - Compliance projects arising from our data analysis

Blood glucose and cholesterol biomarkers project

'may help maintain normal blood glucose levels within the normal range in healthy individuals'

  • Indications related to the:
    • management;
    • control;
    • maintenance; and/or
    • balance
  • of normal, healthy or improved blood glucose or cholesterol:
    • levels;
    • ratios; and/or
    • ranges.

Slide 9 - Compliance projects arising from our data analysis

Blood glucose and cholesterol biomarkers project

  • Evidence requirements
    • High quality
    • Quantifiable data
    • Show how levels are maintained / prevented from falling outside the healthy range
    • Example: blood glucose
      • Reference ranges for normal glucose levels in healthy adults.
Other
glucose

fasting: 3-5.4 mmol/L

random: 3-7.7 mmol/L

According to the Australian Medicines Handbook and Royal Australian College of Pathologists

Slide 10 - Our goals

Our annual goals:

  • respond to more than 200 technical enquiries
  • 500 compliance reviews
  • 200 random reviews
  • 300 target reviews
  • one hundred investigations
  • time to complete a review...140 working days.

Slide 11 - What's in store for the future

Current priorities

  • Evidence: Blood glucose and cholesterol
  • Quality: Aristolochic acids
  • Evidence: Blood glucose and cholesterol
  • Improving education

Upcoming priorities

  • Evidence: Macular degeneration
  • Regulatory reform: Medicines and Medical Devices Review
  • Quality: Sunscreens

Print version

How to access a pdf document