Therapeutic Goods Administration

Half-yearly performance reports
January to June 2014
Version 1.0, October 2014
Document title / Page 1 of 64
V1.0 Month 2012

Therapeutic Goods Administration

About the Therapeutic Goods Administration (TGA)

  • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices.
  • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
  • The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
  • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
  • To report a problem with a medicine or medical device, please see the information on the TGA website

Copyright

© Commonwealth of Australia 2014
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to 0reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <>.

Contents

What the TGA regulates

How the TGA regulates

Regulating medicines

Regulating medical devices

Other therapeutic goods regulated by the TGA

Key observations: January to June 2014

Market authorisation

Postmarket activities

Key statistics

1.Market authorisation

1.1Prescription medicines

1.1.1Workflow of applications

1.1.2Prescription medicines processing times

1.2Over-the-counter medicines

1.2.1Performance during January to June 2014

1.2.2Trend data – July 2013 to June 2014

1.3Export only medicines

1.3.1New applications, variations and processing times

1.3.2Export certifications for medicines

1.4Complementary medicines

1.4.1Registered complementary medicines

1.4.2Ingredients permitted for use in listed medicines

1.5Registration of biologicals

1.6Inclusion of medical devices

1.6.1Medical devices application workflow

1.6.2Medical devices processing times

1.7Inclusion of in vitro diagnostic medical devices

1.7.1IVD medical devices workflow

1.7.2In vitro diagnostic medical device applications processing times

1.8Medical device conformity assessment applications

1.9Export certifications for medical devices

1.10Export permits for blood

1.11Access to unapproved therapeutic goods

1.11.1Clinical Trial Notifications: medicines

1.11.2Clinical trials: medical devices

1.11.3Special Access Scheme: medicines

1.11.4Authorised prescribers

1.11.5Import permits

1.12Orphan drug designations

2.Postmarket activities

2.1Licencing and manufacturing

2.1.1Manufacturing licences

2.1.2Manufacturing certifications

2.1.3GMP clearances

2.2Laboratory testing

2.3Recalls

2.3.1Medicine recalls

2.3.2Medical device and biological recalls

2.4Adverse medicine and vaccine reaction reports

2.4.1Incoming adverse medicine reaction notifications

2.4.2Communications and publications

2.5Listed medicine reviews

2.6Medical device postmarket reviews

2.7Medical device incident reports

2.8Regulatory compliance

3.Australian Register of Therapeutic Goods (ARTG)

3.1New, changed and cancelled records

3.2ARTG product entries

3.3Yearly summary of activities

4.Abbreviations

Management of data from manual sources

What the TGA regulates

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.

As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods.

The TGA is responsible for ensuring that therapeutic goods available for supply in or exported from Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.

The TGA regulates the supply, manufacturing and advertising of these products:

  • medicines prescribed by a doctor or dentist
  • medicines available from behind the pharmacy counter
  • medicines available in the general pharmacy
  • medicines available from supermarkets
  • complementary medicines, these include vitamins, herbal and traditional
  • medicines
  • medical devices, from simple devices like bandages to complex technologies like heart pacemakers
  • products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests; and
  • vaccines, blood products, and other biologics.

How the TGA regulates

The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.

The TGA regulates therapeutic goods through:

  • premarket assessment and market authorisation
  • postmarket monitoring and enforcement of standards; and
  • ensuring manufacturing facilities, whether in Australia or overseas, comply with internationally recognised standards.

Therapeutic goods are divided broadly into three classes: biologicals, medicines and medical devices. Unless exempt, biologicals and medical devices must be 'included' and medicines must be entered as either 'registered' or 'listed' medicines on the ARTG before they may be supplied in or exported from Australia.

If a problem is discovered with a medicine, device or manufacturer, the TGA is able to take a variety of regulatory actions. Possible actions vary and may include continued monitoring through to withdrawing the product from the market or in some circumstances referral to the Commonwealth Director of Public Prosecutions for possible prosecution in relation to criminal offences.


A summary of the processes used in regulation is depicted below:

Regulating medicines

The regulation of medicines includes the following features:

  • classifying the medicine based on different levels of risk to the person taking them
  • implementing appropriate regulatory controls for the manufacturing processes of medicines
  • Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy
  • Ingredients in medicines with a lower risk (medicines purchased over the counter, such as complementary medicines) are required to meet standards for quality and safety
  • Medicines determined to be available for lawful supply by the Therapeutic Goods Administration can be identified by either an AUST R number or an AUST L number on the outer packaging. Please note, there are a small number of medicines that are exempt and do not require this information on the label
  • Once available for supply, medicines are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme that allows safety problems to be identified and actions taken to minimise any further potential for harm to patients.
Regulating medical devices

The regulation of medical devices includes:

  • classifying the medical device based on different levels of risk to the user
  • assessing compliance with a set of internationally agreed essential principles for their quality, safety and performance
  • implementing appropriate regulatory controls for the manufacturing processes of medical devices
  • including the medical device in the Australian Register of Therapeutic Goods
  • once available for supply, medical devices are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event incident reporting programme that allows for early identification of potential safety issues.
Other therapeutic goods regulated by the TGA

The TGA also applies a risk management approach to the regulation of:

  • In vitro diagnostic medical devices (IVDs)
  • blood
  • blood components
  • plasma derivatives
  • tissue and cellular products
  • tissue and cell based derivatives
  • sterilants and disinfectants.

Key observations:January to June 2014

Market authorisation
Prescription medicines
  • The number of Category 1 submissions (application to register a prescription medicine via the standard process) has remained relatively constant over the last year.
  • Category 3 submissions (application to register or vary a registration that does not require clinical, pre-clinical or bioequivalence data) are slightly reduced compared to numbers seen in the July to December 2013 reporting period.
  • The number of submissions other than for Category 1, 2 and 3 submissions hasremained relatively constant overall, although there was a decrease in the number of applications received in the first quarter of 2014.
  • Mean processing times for Category 1 and 3 were well below the statutory timeframes of 255 days and 45 days respectively.
Over-the-counter (OTC) medicines
  • There was a decrease in the total number of applications received during this reporting period, compared with July to December 2013, although there was an increase by approximately 150% in the number of N1 (clone) applications received.
  • There continues to be a high volume of C1 and C2 applications (quality and non-quality changes) compared to new applications.
  • Mean processing times for all types of applications were well below the agreed target timeframes. In addition, the percentage of applications completed within target timeframes was consistently higher than the 80% target.
  • Targets have continued to be revised as a result of ongoing review of the OTC premarket business processes. During January to June 2014, the target time for C2 applications was revised from 75 working days to 64; and an ‘in-process’ target time of 43 days for the initial (C2) evaluation was announced.
Complementary medicines
  • There was one new application received for a registered complementary medicine during January to June 2014.
  • The number of new listed complementary medicines and sunscreens shows variability over time and has increased sharply betweenJanuary and June 2014.
Export only medicines
  • There was a 10% increase in the number of applications for export certifications in 2013–14, compared to the previous financial year. More than 2000 certificates were issued in total.
Medical devices
  • The number of Class III joint reclassification applications received has noticeablyreduced during this reporting period. The total number of Class III applications on hand is continuing to decrease, as TGA processes the large numbers of applications.
  • There was a 65% increase in the number of applications received for inclusion of all classes of in vitro diagnostic medical devices (IVDs) in the Australian Register of Therapeutic Goods.There was a decrease in the number of applications for medical device conformity assessments, including IVDs.
Access to unapproved therapeutic goods
  • Similar to the previous reporting period, there was an increase in the total number of clinical trial applications and new trial notifications in this reporting period.
  • Category B applications for use in patients other than those with terminally ill or seriously ill/life threatening conditions decreased for medicines and medical devices, but increased for biologicals.
Postmarketactivities
Licencing and manufacturing
  • As at 30 June 2014, there were 417 Australian companies holding manufacturing licences covering 455 sites.
  • Between July and December 2013,89% of licence application inspections of Australian manufacturers were found to have satisfactory compliance and a further 10% were found to have marginal compliance.
  • As at 30 June 2014, there were 391 overseas manufacturers covering 391 sites.
  • Between January and June 2014,93% of certification inspections for assessment were found to have satisfactory compliance and a further 7% were found to have marginal compliance.
  • There has been a consistent increase in the number of applications received since 2010. This includes products supplied to sponsors by overseas manufacturers.
Laboratory testing
  • There was a 22% failure rate in the samples and products tested by TGA between January andJune 2014. The most common reason for failure was issues with the formulation of unregistered products.
Therapeutic goodsrecalls
  • Between January and June 2014 there were 20 medicine recalls, 287 medical device recalls and 2 biologicals recalls.
  • The most common reasons for these recalls are physical defects, observed differences, variable content and wrong product (medicines) and mechanical and physical defects (medical devices).
Adverse medicine reaction reports
  • Reporting of adverse medicine reactions reduced by 8% during the reporting period. This decline was mostly due to a reduction in sponsor reports. Reports of adverse reactions for vaccines comprise approximately 20% of all reports, with the majority coming from state and territory health departments.
Regulatory compliance
  • Between Januaryand June 2014, TGA dealt with 558 alleged offences.
  • In general, the number and type of regulatory compliance investigations was similar to the previous reporting period. There was an increase in the number of warnings issued, from 223 between July and December 2013 to 371 between January and July 2014.

Half-yearly performance reports: January to June 2014
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Therapeutic Goods Administration

Key statistics

Total products on the Australian Register of Therapeutic Goods (ARTG) as at 30 June 2014

Category / Number
Biologicals / 2
Prescription medicines / 14,259
OTC medicines / 3249
Listed medicines / 11,647
Registered Complementary Medicines / 175
Export only medicines / 2662
IVDs (including export only IVDs) / 1503
Medical Devices (including other therapeutic goods and export only medical devices) / 44,819
Total / 78,316

Medicines registrations processed by TGA: January to June 2014

Type of medicine registration / Number
Prescription Medicines
New medicine entries / 847
Changes (major and minor) / 9183
Cancellations / 305
Over-the-counter Medicines
New medicine entries / 177
Changes (major and minor) / 178
Cancellations / 107
Registered Complementary Medicines
New medicine entries / 0
Changes (major and minor) / 5
Cancellations / 17

Medicine listings processed by TGA: January to June 2014

Type of listing processed / Number
Medicines for supply in Australia
New medicine entries / 970
Variations / 113
Cancellations / 1490
Medicines for export only
New medicine entries / 54
Changes (major and minor) / 52
Cancellations / 98

Medical devices inclusions processedby TGA: January to June 2014

Medical device inclusions processed / Number
Included medical devices
New entries / 2961
Cancellations / 2649
Included medical devices for export
New entries / 198
Cancellations / 37
Included IVD medical devices
New entries / 283
Cancellations / 8
Included IVD medical devices for export
New entries / 1
Cancellations / 0
Other therapeutic goods
New entries / 10
Cancellations / 84
Other therapeutic goods for export
New entries / 0
Cancellations / 0

Recallinformation: January to June 2014

Recall level / Medicines / Devices / Biologicals
Recalls to consumer level / 2 / 11 / 0
Recalls to retail level / 7 / 12 / 0
Recalls to hospital level / 8 / 262 / 2
Recalls to wholesale level / 3 / 2 / 0
Total / 20 / 287 / 2

Medicines adverse reaction reporting: January to June 2014

Incoming medicines adverse reaction reports / Number
Hospitals / 978
Companies / 4183
General Practitioners / 397
Specialists / 93
Pharmacists / 630
Members of the Public (Consumer) / 298
Nurses, dentists, complementary / 117
State/Territory Health Department / 1636
General list (cause unclear) includes rejected and withdrawn / 952
Total / 9284

Medical device incident reports: January to June 2014

Type of report received / Number
User reports / 458
Sponsor reports / 2593
Total / 3051
Half-yearly performance reports: January to June 2014
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Therapeutic Goods Administration

1.Market authorisation

1.1Prescription medicines

Table 1 Definitions and specified periods (statutory timeframes)

Application category / Definition / Specified period / Working days
Category 1 application / An application to register a prescription medicine via the normal process of evaluation. Examples of Category 1 applications are new substances, extensions of indication, and new routes of administration. / Notification of acceptance or rejection of an application
Completion of evaluation / 40
255
Category 2 application / An application to register a prescription medicine with the same formulation, dosage and indications as in two acceptable countries and for which two independent evaluation reports are available. / Notification of acceptance or rejection of an application
Completion of evaluation / 20
175
Category 3 application / An application to register or to vary the registration of a prescription medicine where the application does not require the support of clinical, pre-clinical or bio-equivalence data, e.g. change in site of manufacture. / Period in which to make a decision or raise an objection
From acceptance to delegate’s decision / 45
45

In the case of prescription medicines, an ‘application’ relates to a single change to a single product. A ‘submission’ includes a number of applications submitted at the one time, in accordance with the Therapeutic Goods Regulations 1990 (the Regulations). The TGA tracks each submission and each product application within each submission.

Category 2 submissions are rarely received. They will only be documented in this report if a submission has been processed.

Half-yearly performance reports: January to June 2014
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Therapeutic Goods Administration

1.1.1Workflow of applications

Table 2 Workflow of Category 1pre-submissions and submissions and Category 3 submissions

2013 / 2014
Apr–Jun / Jul–Sep / Oct–Dec / Jan–Mar / Apr–Jun
Overall
Pre-submissions/submissions received1 / 408 / 474 / 555 / 435 / 501
Submissions finalised2 / 500 / 477 / 545 / 466 / 494
On hand at end of reporting period / 656 / 653 / 663 / 632 / 639
Category 1
Pre-submissions received1 / 108 / 107 / 128 / 110 / 128
Submissions finalised2 / 114 / 127 / 103 / 94 / 112
On hand at end of reporting period / 534 / 514 / 539 / 555 / 571
Category 3
Submissions received / 300 / 367 / 427 / 325 / 373
Submissions finalised2 / 386 / 350 / 442 / 372 / 382
On hand at end of reporting period / 122 / 139 / 124 / 77 / 68

In the case of prescription medicines, an applicant must first lodge a ‘pre-submission’, which provides details of a proposed application, at least 2¼ months prior to lodgement of the full ‘submission’, allowing the TGA to identify milestone dates and plan resource requirements.

1Includes submissions still in the pre-submission stage.

2Includes submissions withdrawn or rejected at acceptance for evaluation stage.

Table 3 Category 1 pre-submissions received by fee category and the number of submitted applications for those pre-submissions

2013 / 2014
Apr–Jun / Jul–Sep / Oct–Dec / Jan–Mar / Apr–Jun
Fee category / Pre-subs / Apps / Pre-subs / Apps / Pre-subs / Apps / Pre-subs / Apps / Pre-subs / Apps
New Chemical Entity / 12 / 35 / 11 / 24 / 13 / 26 / 8 / 38 / 9 / N/A
Extension of indications / 13 / 46 / 7 / 21 / 9 / 22 / 12 / 30 / 8 / N/A
Major variation / 13 / 57 / 10 / 52 / 8 / 28 / 13 / 27 / 12 / N/A
New generic product / 29 / 256 / 43 / 361 / 32 / 309 / 40 / 331 / 31 / N/A
Additional trade name / 14 / 66 / 7 / 42 / 6 / 8 / 10 / 40 / 18 / N/A
Minor variation / 2 / 12 / 4 / 3 / 10 / 3 / 2 / 6 / 1 / N/A
Changes to PI with evaluation / 25 / 79 / 25 / 104 / 17 / 31 / 24 / 57 / 23 / N/A
All Others / 0 / 0 / 0 / 0 / 33 / 0 / 1 / 0 / 26 / N/A
Total / 108 / 551 / 107 / 608 / 128 / 427 / 110 / 529 / 128 / N/A

N/A=Not applicable. As at 30 June 2014, no applications had been received for these pre-submissions.

PI=Product Information; Pre-subs=pre-submissions; Apps=applications.

Table 4Number of submissions other than Category 1, 2 and 3

2013 / 2014
Apr–Jun / Jul–Sep / Oct–Dec / Jan–Mar / Apr–Jun
Safety related request / 180 / 197 / 240 / 168 / 190
Self-assessable request / 389 / 352 / 333 / 261 / 321
Minor editorial change to PI / 76 / 132 / 167 / 123 / 141
Correction of error / 29 / 50 / 37 / 44 / 54
Request for Orphan Drug Designation / 5 / 5 / 5 / 2 / 9
Not yet determined / 0 / 0 / 0 / 0 / 0
Total / 679 / 736 / 782 / 598 / 715

Table 5Outcomes of submissions