Applications to register new or vary existing prescription medicines are accompanied by supportive scientific data and evaluated, with timeframes underpinned by legislation and/or associated business rules.

The framework for prescription medicines includes the following categories which are subject to legislated timeframes:

• Category 1 application: An application to register a new prescription medicine (other than an additional trade name) or to make a variation to an existing medicine that involves the evaluation of clinical, pre clinical or bio-equivalence data. For example, new chemical entities, extensions of indication and new routes of administration.

  The legislated timeframes for the two stages of a Category 1 application are: 40 working days for notification of acceptance or rejection of the application and 255 working days for the completion of the evaluation and notification of the decision.

• Category 2 application: An application accompanied by two independent evaluation reports from comparable overseas regulators in whose jurisdiction the product is approved for the same indication.

  The legislated timeframes for the two stages of a Category 2 application are: 20 working days for notification of acceptance or rejection of an application and 175 working days to notify the applicant of the decision.

• 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. For example, a change in the site of manufacture, a change to the synthetic route, a change in the product specifications, a change in the steps of manufacture or a change in trade name.

  The legislated timeframe for a Category 3 application is 45 working days for notification of acceptance or rejection of an application, completion of evaluation and notification of the decision.

On this page: 1.1. Approval times | 1.2. Submission outcomes | 1.3. Other applications | 1.4. Orphan drug designations

1.1. Approval times

Once an application has been accepted by the TGA, the approval time is defined as the number of TGA working days until a decision is made. As detailed above, this timeframe is underpinned by legislation and excludes public holidays, weekends, the time allocated to the applicant to provide responses to requests for information and 'mutual clock stop' periods agreed with the applicant.

In accordance with the Therapeutic Goods Regulations 1990, a 'submission' may include a number of applications submitted at the one time. The data presented below relates to submissions as this best reflects the evaluation and decision-making processes.

Figure 1 Submissions received 2015-16 to 2016-17

Figure 1 in table format

Figure 1 Submissions received 2015-16 to 2016-17

Application type	Jul 15 - Jun 16	Jul 16 - Jun 17
New chemical entity	43	43
Extension of indication	46	56
New generic medicine	142	100

Figure 2 Mean approval times 2015-16 to 2016-17

Figure 2 in table format

Figure 2 Mean approval times 2015-16 to 2016-17

Application type	Jul 15 - Jun 16	Jul 16 - Jun 17
New chemical entity	193	220
Extension of indication	186	198
New generic medicine	170	182

Figure 3 Median approval times 2015-16 to 2016-17

Figure 3 in table format

Figure 3 Median approval times 2015-16 to 2016-17

Application type	Jul 15 - Jun 16	Jul 16 - Jun 17
New chemical entity	199	208
Extension of indication	195	202
New generic medicine	158	172

1.2. Submission outcomes

1.3. Other applications

In addition to the application types discussed above, we also process numerous other application types. These applications are assessed in accordance with a risk-based approach, for example, some requests are categorised as 'self-assessable' and do not usually involve the evaluation of scientific data. Some applications are received because the sponsors are obliged to inform the TGA of new information related to the safety of their products. Other applications involve editorial corrections to the register entry or the associated product information document. The number of these applications is presented below.

In accordance with the legislation, registered medicines must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, we may grant an 'exemption' from a particular standard for a product. The number of applications approved and rejected is also presented below.

1.4. Orphan drug designations

'Orphan drugs' are often developed to treat small and very specific patient populations who suffer from rare diseases and conditions. The application and evaluation fees for orphan drugs can be waived to help reduce their development costs and facilitate their access to the Australian marketplace. A medicine needs to be designated by the TGA as an orphan drug before an application can be accepted to register it on the ARTG. The designation process involves a review of whether the drug meets the established criteria which are underpinned by legislation.

The quality, efficacy and safety of orphan drugs are assessed at the same standard as for other registered prescription medicines.

Over-the-Counter (OTC) medicine applications are categorised as new medicine (N) or change (C) applications and are further categorised by risk (N1 and C1 are low risk, N5 and C4 are highest risk). The OTC application categorisation framework outlined below defines the different OTC medicine application levels and the key application criteria.

On this page: 2.1 Approval times | 2.2. Applications

2.1 Approval times

Approval time is defined as the number of working days from the acceptance of the application until formal notification of decision. Approval time excludes time where we were unable to progress the application until the sponsor provided additional information unless otherwise specified.

We aim to have 80% of applications completed within target timeframes. Target timeframes for processing of applications are a result of new OTC pre-market business processes and are subject to ongoing review.

1. Of the six N5 applications completed in 2015-16, one was not completed within the target timeframe. This application required referral to the Advisory Committee on Non-prescription Medicines (ACNM), which typically extends the evaluation process by 3-6 months.

2.2. Applications

2.2.1 New OTC medicine applications

2.2.2 Completed applications

2.2.3 Other applications

In addition to the application types discussed above, we also process other application types. This includes requests for advice for the purpose of listing a medicine as a pharmaceutical benefit. The number of requests is presented below.

In accordance with the legislation, registered goods must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, we may grant an 'exemption from a particular standard for a product. The number of applications approved and rejected is also presented below.

1. B1 and B3 requests have recently been implemented. This is the first year for reporting on these application types. Both B1 and B3 applications were approved.
2. Reporting of requests under section 14/14A of the Act has been introduced in this reporting period.

On this page: 3.1. Registered complementary medicines | 3.2. New ingredients permitted for use in listed medicines | 3.3. Listed medicines

3.1. Registered complementary medicines

Registered complementary medicines are considered to be of relatively higher risk than listed medicines based on their ingredients or the indications for the medicine. These medicines are fully evaluated by us for quality, safety and efficacy prior to being accepted on the ARTG.

1. Applications can be made for consent to import, supply or export goods under section 14/14A of the Therapeutic Goods Act 1989.

3.2. New ingredients permitted for use in listed medicines

1. This includes 10 ingredients that were permitted as per the Therapeutic Goods (Listing) Notice 2015 (No. 4) following TGA initiated assessments.
2. This includes a large number of ingredients that were made available for excipient use in specific circumstances in listed medicines following TGA initiated assessments.

3.3. Listed medicines

Section 9D of the Therapeutic Goods Act 1989 provides for variations to be made to an entry on the ARTG in a set of limited and prescribed circumstances. These circumstances include where information included on the ARTG is incomplete or incorrect.

1. Sponsors can apply for certain exemptions under Section 14 of the Therapeutic Goods Act 1989. Applications seek consent to import, export or supply a complementary medicine that does not comply with the applicable standards.Listed medicine reviews

3.3.1 Investigations

Investigations include complaints and referrals from internal and external stakeholders and screening of recently listed medicines on the ARTG, but can also include products not listed on the ARTG. All investigations are assessed and triaged based on a risk management approach to provide the greatest overall benefit for the Australian public. Investigations may be completed through a number of mechanisms, such as initiating a targeted review or referral to another area of the TGA.

1. The outcome 'no further action taken' includes examples where the investigation was resolved by other means such as the product has been or is currently under review; the complaint was not justified and did not warrant further action; or advice was provided to the complainant.

3.3.2 Compliance reviews

Listed medicines are not evaluated by the TGA before they are included on the ARTG. However, a proportion is reviewed to check their compliance against relevant regulatory requirements. Compliance reviews may only review selected listing requirements.

Medicines may be randomly selected or targeted for a review. Medicines are randomly selected for review by a computer, based on a mathematical model. Targeted reviews can originate from a number of signals and are initiated following an investigation.

A compliance review will result in one of the following outcomes:

• no compliance breaches are identified against selected listing requirements, the review is concluded and the medicine remains on the ARTG
• compliance breaches are identified for the selected listing requirements
• the review is not completed as the sponsor has cancelled the medicine
• the review is closed due to the unavailability of information in determining its compliance status.

Figure 4 Outcomes of compliance reviews by reason for initiation

In this period, we have performed a higher proportion of targeted reviews than in 2015-16. We initiated a number of targeted compliance projects based on the compliance data obtained from the previous reporting period. These projects have covered oral probiotics indicated for vaginal conditions and listed medicines with blood glucose and cholesterol indications. Of the reviews where we were able to determine a compliance status, 79% had verified compliance breaches, which is consistent with the non-compliance rate from the previous period, despite the different proportion of random to targeted reviews.

Table 22 Types of listed medicine compliance issues identified

Of the completed compliance reviews, the following are the types of issues identified in those medicines where a compliance breach was verified. Individual medicines may have multiple issues.

1. In previous reports 'Labelling', 'Advertising' and 'Unacceptable presentation' were reported collectively as 'Labelling and/or advertising'. The 2015-16 data has been updated to incorporate the additional breakdown of categories. 'Unacceptable presentation' includes the presentation (labelling, packaging and any advertising material) being misleading to consumers and text and graphics being unacceptable.
2. 'Evidence' means the evidence held by the sponsor does not support the claims relating to the medicine.
3. 'Safety' means that the medicine is not safe for the purposes for which it is to be used.
4. In previous reports 'other' included non-response to a request for information. However this is now being reported separately.

Figure 5 Types of compliance issues identified by reason for initiation

Table version of Figure 5

Compliance issue	Random reviews	Targeted reviews
Evidence	23%	23%
Unacceptable presentation	22%	15%
Advertising code	10%	12%
Labelling	27%	17%
Quality	6%	9%
ARTG entryc	9%	19%
Safety	1%	4%
Non-response to RFIa	1%	1%
Otherb	1%	0%

Figure 5 shows the types of compliance issues that are identified through reviews which are either randomly selected or targeted for a particular issue. Multiple breaches may be identified for each medicine that is found to be non-compliant; for example, 54% of non-compliant medicines were found to have insufficient evidence to support the medicine indication, yet this breach accounted for 23% of the total breaches identified across all non-compliant medicines.

1. 'RFI' refers to 'Requests For Information'.
2. 'Other' compliance issues may include the sponsor failing to comply with a condition that the medicine is subject to.
3. 'ARTG entry' broadly refers to situations where the information on the ARTG is incorrect, including indications that are not eligible for listing and ingredients that do not comply with listing requirements.

For both random and targeted reviews, the most common compliance issues have consistently been labelling/ advertising and evidence issues. For targeted reviews in 2016-17, there was a slightly higher proportion of compliance issues related to the ARTG, quality or safety, whereas in 2015-16 there was a significantly higher proportion of evidence and labelling/advertising issues. This is likely to be the result of a number of targeted compliance projects undertaken during this period that focussed on these issues.

1. In some targeted review projects, sponsors are sent a 'warning' letter instead of a 'proposal to cancel' letter. A proposal to cancel or warning letter are considered the same for reporting purposes.
2. The figures provided under 'Actions following a Proposal to Cancel notice' are a breakdown of the figures provided under 'Actions following a Request for Information'.

Figure 6 Outcomes of completed compliance reviews

Table version of Figure 6

Outcome	Percent
Compliant	21%
Compliant after Proposal to Cancel or warning	55%
Cancelled by sponsor request after Proposal to Cancel or warning	20%
Cancelled by TGA after Proposal to Cancel or warning	4%

Figure 6 shows that a significant proportion of listed medicine reviews are concluded after the sponsor has adequately addressed the compliance breaches identified by us. Under the Therapeutic Goods Act 1989 sponsors are given an opportunity to respond to issues raised during a compliance review. There was a slight decrease in the number of listed medicines cancelled by the TGA following a Proposal to cancel or warning letter (4%) compared with the previous period (11%). The high proportion of listed medicines that are brought back into compliance after a Proposal to cancel, combined with the decrease in listed medicines cancelled by the TGA, shows that industry is willing to work with us to ensure the supply of listed medicines on the ARTG is compliant.

The Australian Regulatory Guidelines for Biologicals define the different biological classes.

4.1. Inclusion of biologicals

1. Technical Master Files (TMF) contain information from manufacturers that demonstrate how product safety and quality standards have been met for Blood, Blood Components and Haematopoietic Progenitor Cells.
2. Plasma Master Files contain control strategies that ensure the quality and safety of plasma, from collection through to plasma pooling prior to fractionation and including donor selection criteria and testing, which are part of medicinal products or medical devices.

5.1. Adverse medicine and vaccine reaction notifications

The Medical Devices Regulatory Framework spans the life cycle for these products, including:

• Conformity assessment: Is the systematic examination by the manufacturer to determine that a medical device is safe and performs as intended and, therefore, conforms to the Essential Principles. Certification of the manufacturer's conformity assessment procedure may (and in some cases must) be undertaken by the TGA, or we may recognise conformity assessment certification from European notified bodies.
• Inclusion on the ARTG: Medical devices cannot be imported, supplied in, or exported from Australia unless they are included on the ARTG or a valid exemption applies, for example custom made medical devices, importation of samples, etc. A sponsor can apply to include a medical device on the ARTG if the device complies with the Essential Principles and appropriate conformity assessment procedures have been applied to the device (typically demonstrated through conformity assessment certification).
• Post-market monitoring: Once a medical device has been included on the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.

6.1. Conformity assessment

6.1.1 Applications

1. Due to a correction in coding, a small variation has occurred to the data.

6.1.2 Outcomes

Table 30 has been broken down into 'New' and 'Variation' assessment application to provide additional transparency and understanding. In reviewing the changes in reporting the final total was increased by one, as per updates to operational data.

6.1.3 Processing times

We are required to complete conformity assessment applications within 255 working days.

Processing time is defined as the number of working days from the acceptance of the application until formal notification of decision. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends. Processing time excludes time where we were unable to progress the application until the sponsor provided additional information unless otherwise specified.

During 2016-17, 100% of conformity assessment applications were completed within 200 working days.

6.2. Inclusion of medical devices (including IVDs)

6.2.1 Applications

1. Class I medical devices are automatically included (i.e. these applications are completed within 24 hours). There are no applications for this classification of device 'on hand'. Differences in the number received and finalised relate to those applications received on the last day of the reporting period and/or technological errors occurring in the system.
2. Applications on hand - figures shown are correct as of the date when the data was extracted. There may also be delays between the date of the decision and the time when the system is updated due to administrative and/or technological processes.
3. The transition period for joint reclassification finished on 30 June 2015. A large number of applications were received at the end of this transition period, late in the January to June 2015 reporting period. As the transition period has now finished Class III joint reclassification applications will be rolled into the general Class III applications in future reports.
4. The number of applications for Class 1 IVD includes auto-included devices and applications completed with or without audit.

6.2.2 Outcomes

Class I automatically included medical devices are not counted in the outcomes for inclusion applications as these applications cannot be rejected.

1. The IVD transition period ended on 30 June 2015, with a number of applications received late in the transition period. The higher number of applications completed in 2015-16 reflected the end of this transition period.

6.2.3 Processing times

The agreed target time for Level 1 application audits is 30 TGA work days and for Level 2 application audits is 60 TGA work days (reflected in 'TGA days'). This does not include the period we are waiting for information or payment of fees (reflected in 'sponsor days').

1. TGA time starts when the application is selected for audit, and does not include public holidays and weekends, and the time when we wait for information or payment from the sponsor.
2. Auto-included applications for Class I and Class 1 IVD are complete within 24 hours, and not included in the figures above.
3. Non-compulsory audit – estimate for the audit processing time does not include applications for reclassification of joint replacement medical devices received during transitional period (Class III Joint Reclassification medical devices), and applications supported by European Community (EC) certificates issued by certain notified bodies.

6.3. Post-market monitoring

6.3.1 Compliance reviews

As Class I medical devices are automatically included on the ARTG, we undertake post-market compliance reviews for these devices. This includes restricted word reviews, where applications for Class I devices are identified by the use of specific words indicative of risk, or listing issues relating to the inclusion of the device.

We also conduct targeted compliance reviews that are initiated on a case by case basis. These may be conducted in relation to devices of any Class.

6.3.2 Post-market reviews

We also undertake a range of post market reviews.

6.3.3 Medical device incident reports

Processing time is defined as the number of working days from the receipt of the notification until the incident has been investigated and resolved. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends.

The target timeframe for processing of medical device incident reports is 90 working days.

1. Outcomes are not mutually exclusive.

6.3.4 Devices manufacturing

1. The improvement in processing times for initial audits was the outcome of process improvement resulting in more timely internal notification of required audits, and more up to date status of manufacturers due to the Medical Devices Single Audit Program (MDSAP).

1. The improvement in processing times for initial audits was the outcome of process improvement resulting in more timely internal notification of required audits, and more up to date status of manufacturers due to the MDSAP.

Processing time is defined as the number of working days from the acceptance of the application, including payment, until formal notification of decision. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends. Processing time excludes time where we were unable to progress the application until the sponsor provided additional information unless otherwise specified.

On this page: 7.1. Export only medicines | 7.2. Export certifications for medicines | 7.3. Export certification assessment for medical devices | 7.4. Blood permits for export

7.1. Export only medicines

The target timeframe for processing of export only medicine applications and variations is 31 working days.

7.2. Export certifications for medicines

The target processing time for applications for an export certificate for a medicine is 15 working days.

1. We aim to have 100% of applications processed within the target timeframe.

7.3. Export certification assessment for medical devices

The target processing time for applications for an export certificate for a medical device is 5 working days.

1. We aim to have at least 90% of applications processed within the target timeframe.

7.4. Blood permits for export

We issue permits to export human blood and its fractions (products derived from human blood) on receiving written applications from medical professionals, hospitals and bone banks. Most often these professionals or health organisations approach the Australian Red Cross Blood Service which then applies for the permit on their behalf. Very rarely an individual citizen may also apply with reference to his/her requirement, for example, a patient travelling overseas with Biostate® injections, which is a blood fraction and requires a permit to take it out of Australia.

In addition to issuing individual permits, the TGA also issues annual permits. Applications for these permits are submitted by commercial (pharmaceutical companies) or government organisations (such as the Australian Defence Force). The permits cover one year's worth of anticipated export supplies for these organisations.

Figure 7 Number of blood permits processed

Figure 7 in table format

Figure 7 Number of blood permits processed

Permit type	Jul 15 - Jun 16	Jul 16 - Jun 17
Bone and tissues	50	46
Blood and fractions	144	104
Annual blood permits	33	46

On this page: 8.1. Special Access Scheme | 8.2. Clinical trials | 8.3. Authorised Prescribers

8.1. Special Access Scheme

The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. For this reporting period, two pathways existed under the scheme and they are categorised as follows:

• Category A is a notification pathway which can only be accessed by medical practitioners for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
• Category B is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition. An approval letter from TGA is required before the goods may be accessed.

Any unapproved therapeutic good can potentially be supplied via the SAS except for drugs of abuse in Schedule 9 of the Poisons Standard (where the manufacture, possession, sale or use is prohibited by State or Territory law) which cannot be accessed through the SAS Category A process.

8.2. Clinical trials

The Clinical Trial Notifications (CTN) scheme provides an avenue through which unapproved therapeutic goods may be lawfully supplied for use solely for experimental purposes in humans. Unapproved therapeutic goods can include biologicals, devices or medicines or a combination of any of the three types of goods.

1. 'Device' includes both medical device and therapeutic device categories.

1. In previous reports 'Device' was not available as a phase category under the previous CTN system.
2. It is now always possible to specify phase and the 'None specified' category will no longer be used.

1. Device includes both medical device and therapeutic device categories.

The online system captures the actual number of notifications received for new clinical trials and requests to change significant details to clinical trials already notified. A variation to a previously notified clinical trial may include an addition of a site(s), change to a therapeutic good, or change in principal investigator etc.

1. A variation may include any change to a previously notified clinical trial such as an additional site, change to a therapeutic good, or change in principal investigator.
2. In previous reports 'Device' was not available as a phase category under the previous CTN system.
3. It is now always possible to specify phase and the 'None specified' category will no longer be used.

8.3. Authorised Prescribers

The Authorised Prescriber Scheme allows approved medical practitioners authority to prescribe a specified unapproved therapeutic good(s) to patients who are identified by their medical condition. If a medical practitioner becomes an Authorised Prescriber they may prescribe the product to patients in their immediate care, within the indication specified, without seeking further approval from the TGA.

On this page: 9.1. Manufacturing licences issued to Australian manufacturers | 9.2. Approval (certification) of overseas manufacturers | 9.3. Good Manufacturing Practice clearances

9.1. Manufacturing licences issued to Australian manufacturers

As at 30 June 2017, there were 247 Australian companies holding manufacturing licences covering 387 sites.

The 2016-17 data excludes inspections conducted for Australian medical devices manufacturers. This information is now reported under medical devices as Quality Management System (QMS) audits of Australian manufacturers.

The number of initial inspections conducted within 3 months of application improved in 2016-17 due to improved internal processes and focused efforts on ensuring initial inspections were conducted in a timely manner.

9.2. Approval (certification) of overseas manufacturers

As at 30 June 2017, there were 206 overseas manufacturers covering 207 manufacturing sites that were subject to TGA inspection and approximately 2,700 overseas manufacturing sites that relied on evidence from recognised regulators.

The 2016-17 data excludes inspections conducted for overseas medical devices manufacturers. This information is now reported under medical devices as QMS audits of overseas manufacturers.

The number of initial overseas inspections conducted within six months of application improved in 2016-17 due to improved internal processes and focused efforts on ensuring initial inspections were conducted in a timely manner.

9.3. Good Manufacturing Practice clearances

GMP clearance is required for all medicines (unless exempt) supplied in Australia. This includes products supplied to sponsors by overseas manufacturers.

On this page: 10.1. Medicine recalls | 10.2. Medical device recalls | 10.3. Biological recalls

10.1. Medicine recalls

1. 'Other' includes dissolution, physical defects, observed differences, variable content, diagnostic inaccuracy and wrong product, disintegration/dissolution, GMP non-compliance and transport/storage.

10.2. Medical device recalls

1. 'Other' includes bioavailability, disintegration/dissolution, microbial contamination, variable content, foreign matter, impurity, wrong product, therapeutic inefficiency and observed differences.

10.3. Biological recalls

The Laboratories Branch conducts post-market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment of therapeutic goods.

The Laboratories Branch identifies and prioritises therapeutic goods for testing to fulfil the regulatory compliance and monitoring requirements of the TGA, and the transparency and accountability requirements of government. The testing program also provides flexibility and capacity to provide testing for investigations into problem reports, complaints and urgent public health concerns.

A risk management approach is used, which is consistent with ISO 31000: Risk Management principals and guidelines, to identify products with a higher risk of not complying with the required quality standards. This risk based, targeted approach to testing is reflected in the failure rates reported in the table below.

The Database of TGA Laboratory Testing Results was launched in the first half of 2017 to provide information to the public about the 2000-plus samples we test each year, and to increase understanding of how our testing program contributes to the regulation of therapeutic goods. Consumers and health professionals can now clearly see which products have been tested by the TGA, whether they passed or failed, and for those that did fail what regulatory action was taken. Providing this information has been an important enhancement to the transparency of the Government's regulatory processes and the vital role of the TGA in ensuring the quality, safety and efficacy of medicines and medical devices for Australian consumers.

1. Performed on request for overseas regulators or aid agencies and encompasses medicines and medical devices.
2. Unregistered refers to products that meet the definition of therapeutic goods but are not included on the ARTG or otherwise specifically exempted from this requirement in the legislation. This often includes adulterated complementary medicines or counterfeit products.
3. Includes accreditation, harmonisation and quality control (AHQ) samples.
4. The TGA may test a number of samples of each product per reporting period.

1. Evaluation of batch release documentation for vaccines, biotechnology and blood products.
2. Certification of biological products being exported from Australian manufacturers to overseas markets.

The Laboratories Branch provides WHO-approved certificates for batches of biological products to be exported by Australian manufacturers to overseas markets. The number of certificates provided by the Laboratories Branch therefore depends on the number of requests received.

Testing on products linked to potential public safety concerns are assigned to the 'Urgent' testing category. Urgent testing may impact on the timeframes for priority and routing testing.

Priority is given to testing of products with the highest risk of a quality deficiency.

Compliance against these timeframes is outlined in the table below.

Low numbers of samples within categories may affect compliance percentages.

Samples involving complex biological assays are excluded from the target turnaround timeframes.

The TGA Regulatory Investigations and Enforcement Unit conducts compliance and enforcement activities against a risk based compliance framework. Using principles of responsive regulation, a range of tools are utilised including encouragement and guidance to comply, restrictions or warnings, suspensions or sanctions and cancellations. At the apex, activities including investigations into illegal import or manufacture of unapproved and counterfeit therapeutic goods can result in criminal or civil court action. All compliance activities have the intended purpose of protecting public health.

1. Due to a change in reporting function, the number of units can now be captured. Units refers to single dosage unit e.g. 1 tablet, 1 capsule, 1 tub of powder or single device.

1. Regulatory compliance investigations may include more than one type of product.

1. Products that fall outside the remit of the Therapeutic Goods Act 1989, for example food products.

1. Other includes investigations of anonymous (unknown) origin.