Half yearly performance snapshot: July to December 2016

1 July to 31 December 2016

3 March 2017

Introduction

The Therapeutic Goods Administration reports on its performance against the Regulator Performance Framework (the Framework). The Framework came into effect on 1 July 2015 and our first report, covering the period 1 July 2015 to 30 June 2016, was published on the TGA website in November 2016 (TGA key performance indicators and measures: Regulator Performance Framework).

To provide stakeholders with a progress update and assist with charting our performance, the TGA also releases a Half Yearly Performance Snapshot (the Snapshot). This Snapshot covers the period of 1 July to 31 December 2016.

Performance highlights

The six months from 1 July to 31 December 2016 was a period of significant activity for the TGA. Highlights are as follows:

Medicines

Prescription medicines

  • A significant workload continued, with 156 Category 1 (including 23 New Chemical Entities (NCE) and 53 new generic medicines) and 665 Category 3 applications approved. While this represents a slight decrease against the equivalent period in 2015, where 193 Category 1 and 685 Category 3 applications were approved, many applications, particularly related to cancer medicines, are increasingly more complex in nature.
  • The mean and median approval times for Category 1 NCE (200 and 205 working days respectively) and Category 3 minor variation applications (between 22 and 24 working days) were well below the statutory timeframes of 255 days and 45 days respectively.
  • The mean and median approval times for new generic medicines (177 and 161 working days respectively) and Product Information changes (142 and 138 working days) were below that of NCE as these application types are typically processed without referral to independent expert advisory committees.

Over-the-counter medicines

  • The number of new medicine applications (N1 to N5) approved during this period (77) increased slightly compared to January to June 2016 (59) but was within the variability of previous periods.
  • The percentages of applications completed within target timeframes were well above the 80% target (95% for C1 applications and 100% for all other application types). Business process reform and a streamlined submission process have led to efficiencies in completing applications within target timeframes.

Complementary medicines

  • The number of new ingredients permitted for use in listed medicines increased substantially compared to the corresponding period in 2015 (from 14 to 50), largely due to new ingredients being made available for excipient use in specific circumstances in listed medicines. Two updates were made to the Permissible Ingredients Determination under section 26BB of the Therapeutic Goods Act 1989 (the Act) to enable the use of these ingredients in listed medicines.
  • We increased the number of initiated targeted reviews from 89 to 235 based on the data gathered from random compliance reviews conducted in 2015-16. We identified trends in non-compliance and initiated projects targeting groups of listed medicines based on non-compliance issues. These were published on our website at a dedicated compliance page.
  • Increased targeted reviews resulted in the proportion of medicines with verified compliance breaches being 80% (167) for this period, compared with 72% (136) in the corresponding period in 2015.

Medical devices

  • A total of 258 Level 2 compulsory audits which include the assessment of clinical evidence were completed in this period compared to 107 in the corresponding period in 2015. Whilst during 2016 there were delays in commencing the clinical assessment component for high risk (Class III and Active Implantable Medical Devices) application audits resulting in process times of around eight to nine months, we have introduced a range of strategies to address this issue and reduce the wait time for assessments.

Licensing and manufacturing

  • We have revised our business practices to apply a risk-based approach to the scheduling of inspections for the manufacture of medicines and biologicals, resulting in significant improvements in processing times. Specifically, this period has seen a 16% increase of initial inspections conducted of Australian manufacturers and a 25% increase of initial certifications of overseas manufacturers compared with the equivalent 2015 reporting period. These improvements have been achieved by focusing on initial inspections as opposed to re-inspections and taking into account any history of consistent compliance with Good Manufacturing Practice (GMP) guidelines over time.
  • As at 31 December 2016, there were 252 companies holding Australian manufacturing licences covering 396 sites; and 397 overseas companies holding manufacturer certificates covering 399 manufacturing sites.

Access to unapproved therapeutic goods

Clinical trials

  • There was a slight reduction in the number of Clinical Trial Notifications (CTN) received (417) compared to the corresponding period in 2015 (469).
  • Ongoing modifications to the online CTNs form have been made to improve its functionality for clinical trial sponsors.

Special Access Scheme

  • The number of completed applications and notifications under the Special Access Scheme for Category A medical devices increased (from 1,960 to 2,832) compared to the corresponding period in 2015.

Authorised Prescriber Scheme

  • There was an increase in the number of authorised prescriber approvals for medicines (from 297 to 391) and medical devices (from 121 to 177) compared to the corresponding period in 2015.

Medicine and vaccine adverse event reports

  • We have worked closely with stakeholders to highlight the importance of reporting adverse events to the TGA. The National Prescribing Service (NPS) hosts an online learning module for health professionals and in April 2016 we undertook online advertising using Google and health professional publications. This resulted in increased awareness and completion rates of the NPS modules, especially in the nursing profession. There was an increase of 1,371 in notifications of medicine and vaccine adverse events compared to the equivalent 2015 reporting period.

Laboratories

  • Between 1 July and 31 December 2016, 1,229 samples were tested and a total of 6.9 million doses of 53 different vaccine products were released.

Regulatory compliance

  • The number of products subject to investigation for compliance issues increased by 111% from the equivalent 2015 reporting period. We attribute increased reporting of non-compliance to online educational material informing the Australian public about the dangers of importing medicines and medical devices not approved for supply in Australia and without medical supervision. We have also enhanced our relationships with government stakeholders with responsibility for law enforcement, consumer protection and the health of Australians.
  • We facilitated the destruction of a total of 336,119 'units[1]' of imported therapeutic goods. These therapeutic goods were imported outside of the TGA regulatory scheme and treated as prohibited imports under the Customs Act 1901 resulting in seizure and destruction by the Australian Border Force (ABF). Reporting on the destruction of these units commenced this reporting period and will be incorporated into subsequent reports.
  • Ten products were established to be counterfeit therapeutic goods presenting a risk to public health. Safety alerts were published on the TGA website and the ABF was notified.

Recalls

  • Initial review of 90% of the safety related recall (i.e. Class I and II) actions for medical devices, medicines and biologicals managed during the reporting period was undertaken within the target timeframe of two working days from the date of notification.

Footnotes

Processing and approval times

1 July to 31 December 2016

Processing and approval times are defined as the number of working days from the acceptance of the application until formal notification of decision, unless otherwise specified. These exclude time where we were unable to progress the application until the sponsor provided additional information or payment of fees, unless otherwise specified. Under the Act, TGA working days exclude public holidays and weekends.

1. Prescription medicines

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.
  • 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.
  • 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.

Figure 1 Number of approved Category 1 submissions by type for July to December 2016

Prescription medicine submissions may include a number of applications submitted at the one time. The data presented below relates to the number of submissions as this best reflects the evaluation and decision-making processes.

Number of approved Category 1 submissions: 30 - Changes to product information, 23 - New chemical entity, 4 - New fixed-dose combination, 20 - Extensiont of indication, 53 - New generic medicine, 1 - Additional trade name, 24 - Major variation, 0 - Minor variation type G, 1 - Minor variation type H

Table 1 Prescription medicine application approval time for July to December 2016
Approval time (TGA working days)
Application type Submissions approved Legislated timeframe Mean Median Range
A: New chemical entity
Category 1 23 255 200 205 161-238
B: New fixed-dose combination
Category 1 4 255 201 204 179-218
C: Extension of indication
Category 1 20 255 199 206 147-238
D: New generic medicine
Category 1 53 255 177 161 124-253
E: Additional trade name (ATN)[a]
Category 1 1 255 237 237 N/A
ATN 14 45 29 30 13-42
F: Major variation
Category 1 24 255 188 195 134-224
G: Minor variation[b]
Category 1 N/A 255 N/A N/A N/A
Category 3 39 45 23 24 8-40
H: Minor variation[c]
Category 1 1 255 111 111 N/A
Category 3 626 45 23 22 1-49
J: Changes to product information requiring the evaluation of data
Category 1 30 255 142 138 65-212
  1. In July 2015, a legislated 45 working day process for ATN submissions commenced. During the current reporting period, submissions have been processed under both the Category 1 and ATN processes.
  2. The type G minor variations differ from type H minor variations in that they result in a new Australian Register of Therapeutic Goods (ARTG) entry.
  3. The minor variations (type H) included in the table above refer to applications to change the formulation, composition or design specification or the container for the goods or any other attribute that results in the goods being separate and distinct. These applications are typically 'Category 3' changes, unless the supporting scientific package contains non-clinical or clinical data in which case the application is a 'Category 1' application.

Further information about how prescription medicines are regulated in Australia can be found on the TGA website.

2. Over-the-Counter 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 lowest risk, N5 and C4 are highest risk).

Application category Definition
N1 An application submitted as a 'Clone'.
N2 An application which complies with an OTC medicine monograph.
N3 New application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4.
N4

An application for a 'generic' medicine where the medicine:

  • requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing such data; and/or
  • requires a higher level of assessment due to the umbrella branding segment of the product name; and/or
  • has not been previously registered as an OTC medicine following down-scheduling
N5 An application for a new product that is an extension to a 'generic category' product or an application for a product containing a new chemical entity as an active ingredient.
C1 Quality and non-quality changes classified as 'negligible risk'.
C2 Quality and non-quality changes classified as 'low risk' - no safety and/or efficacy data required; quality data may be required.
C3

Quality and non-quality changes classified as 'low risk' - safety and/or efficacy data required unless justified; quality data may be required.

Umbrella branding segment of new name requires a higher level of assessment.

C4 Non-quality changes classified as 'moderate risk' - safety and/or efficacy data required unless justified.
Table 2 Over-the-Counter medicine application processing time for approved applications for July to December 2016
Total approved Target approval time (days) Mean Median Range Percentage within target
New medicine applications
N1 Lower risk 47 45 27 28 0-41 100
N2 7 55 42 43 37-47 100
N3 9 150 66 68 16-123 100
N4 8 170 86 74 67-124 100
N5 Higher risk 6 210 183 193 138-196 100
Change applications
C1 Lower risk 218 20 9 8 0-29 95
C2 121 64 18 10 0-62 100
C3 7 120 30 14 10-107 100
C4 Higher risk 1 170 86 86 86-86 100

Further information about how OTC medicines are regulated in Australia can be found on the TGA website.

3. Complementary medicines

3.1. Registered complementary medicines

Table 3 Number of approved registered complementary medicine applications
2015
Jul-Dec
2016
Jul-Dec
New registered medicines 2 4
Variation to registered medicines 14 11

Further information about how registered complementary medicines are regulated in Australia can be found on the TGA website.

3.2. Listed complementary medicines

Table 4 Number of new ingredients permitted for use in listed medicines
2015
Jul-Dec
2016
Jul-Dec
New permitted ingredients 14 50
Table 5 Number of new listed medicines
2015
Jul-Dec
2016
Jul-Dec
New listed medicines 919 754
Table 6 Number of listed medicine reviews by type
2015
Jul-Dec
2016
Jul-Dec
Reviews initiated
Random reviews 197 O
Targeted reviews 89 235
Total 286 235
Reviews completed
Random reviews 153 83
Targeted reviews 67 168
Total 220 251
Table 7 Number of completed listed medicine reviews by outcome
2015
Jul-Dec
2016
Jul-Dec
Compliance status determined
Medicines with no compliance breaches 53 43
Medicines with verified compliance breaches 136 167
Sub-total 189 210
Compliance status unable to be determined
Medicines cancelled by sponsors after request for information 20 8
Medicines not yet manufactured or information unavailable 9 33
Other 1 0
Sub-total 30 41
Product not a therapeutic good 1 0
Total completed 220 251

Further information about how complementary medicines are regulated in Australia can be found on the TGA website.

4. Biologicals

Blood, blood components, plasma derivatives, tissue and cellular products, tissue and cell based derivatives, and other emerging biological therapies are regulated under the Therapeutic Goods Act 1989.

Table 8 Number of completed biological applications
2015
Jul-Dec
2016
Jul-Dec
Technical Master File (TMF) new 0 1
TMF annual updates 2 5
TMF variations 4 7
TMF notifications 2 7
Plasma Master File annual updates 8 8
Biological Class 2 - new applications 4 0
Biological Class 3 - new applications 0 1
Biological Class 2 - variations 9 10
Biological Class 3 - variations 1 0
Total completed 30 39

Further information about how biological products are regulated in Australia can be found on the TGA website.

5. Medical Devices

The regulatory framework for medical devices spans the life cycle of these products, including conformity assessment, inclusion on the ARTG and post-market monitoring.

Table 9 Number of completed applications and processing time for conformity assessments of medical devices (including in vitro diagnostic medical devices (IVDs))
2015
Jul-Dec
2016
Jul-Dec
New devices
Total completed 42 29
Percentage processed within target processing timeframes 100% 100%
Mean TGA processing time (working days) 137 118
Median TGA processing time (working days) 178 133
Changes or recertification
Total completed 53 63
Percentage processed within target processing timeframes 100% 100%
Mean TGA processing time (working days) 83 100
Median TGA processing time (working days) 57 76

The TGA is required to complete conformity assessment applications within 255 working days.

Table 10 Number of completed applications for inclusion of medical devices and IVDs on the ARTG
2015
Jul-Dec
2016
Jul-Dec
Class I medical devices 1,317 1,209
Class I measuring medical devices 19 25
Class I sterile medical devices 124 136
Class IIa medical devices 619 642
Class IIb medical devices 386 345
Class III medical devices 130 228
Class III Joint Reclassification medical devices 209 114
Active Implantable Medical Devices (AIMD) 7 56
Class 1 IVDs 71 41
Class 2 IVDs 94 38
Class 3 IVDs 107 21
Class 4 IVDs 20 6
Table 11 Number of application audits completed and processing time for medical devices and IVDs for July to December 2016
Total completed Processing time
Mean Median
Medical devices
Auto-included applications[a] 1,209
Applications completed without audit 1,091[b] 4 3
Non-compulsory audits[c] 172 57 22
Level 1 compulsory audits 25 12 11
Level 2 compulsory audits 258 171 175
IVDs
Auto-included applications[a] 34
Applications completed without audit 32[b] 5 4
IVD non-compulsory audit 5 72 54
IVD compulsory audit 35 51 40
  1. Class I and Class 1 IVDs are automatically included medical devices and are not subject to audits before inclusion. Separate post-market monitoring is undertaken for these goods.
  2. These figures do not include applications for Class I and Class 1 IVD auto-included devices. These applications are completed within 20 working days.
  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 certificates issued by certain notified bodies (for details see Increased application audit requirements for some medical devices applications).

6. Exports

Table 12 Number of completed applications for export-only medicines and export certifications and relevant processing time for July to December 2016
Total completed Target processing time (days) Mean Median
Export-only medicines
New application 117 30 24 28
Variation 36 30 22 23
Export certificates
Medicine applications 715 15 12 12
Medical device assessments 255 5 5 4

Completed applications include applications that were approved and withdrawn.

7. Access to unapproved therapeutic goods

7.1. Special Access Scheme

Table 13 Number of completed applications and notifications for the Special Access Scheme
2015
Jul-Dec
2016
Jul-Dec
Medicines
Category A 20,688 20,194
Category B 9,583 10,377
Medical devices
Category A 1,960 2,832
Category B 993 979
Biologicals
Category A 22 6
Category B 1,500 1,091

Further information about the Special Access Scheme can be found on the TGA website.

7.2. Authorised prescribers

Table 14 Number of authorised prescriber approvals for medicines and medical devices
2015
Jul-Dec
2016
Jul-Dec
Medicines 297 391
Medical devices 121 177

Further information about authorised prescribers can be found on the TGA website.

7.3. Clinical trials

Table 15 Number of notifications for new clinical trials received by therapeutic good type for July to December 2016
2015
Jul-Dec
2016
Jul-Dec
Medicine only 244 197
Medical device only 65 71
Biological only 9 3
Medicine and medical device 132 127
Medical device and biological 5 1
Medicine and biological 9 11
Medicine, medical device and biological 5 7
Total 469 417
Table 16 Number of notifications for new clinical trials received by phases for July to December 2016
2015
Jul-Dec
2016
Jul-Dec
Phase 1 98 72
Phase 1 and 2 in combination N/A[a] 11
Phase 2 110 82
Phase 2 and 3 in combination N/A[a] 4
Phase 3 155 113
Phase 4 71 41
Bioavailability / equivalence 16 13
Other phases in combination N/A[a] 25
None specified 72 0
Device only N/A[a] 56
  1. This information was not separately captured at this time.

It should be noted that a trial may be notified with more than one phase type.

Further information about clinical trials can be found on the TGA website.

8. Licensing and manufacturing

Number of manufacturing inspections by outcome

Table 17A - Medicines and Blood, Tissue and Cellular Therapies
2015
Jul-Dec[a]
2016
Jul-Dec[b]
Outcomes of inspections of Australian manufacturers
Number of inspections conducted 114 74
Satisfactory compliance (of completed inspections) 63%[a] 82%[b]
Marginal compliance (of completed inspections) 18%[a] 16%[b]
Unacceptable (of completed inspections) 1%[a] 2%[b]
Close-out in progress 18%[a] 16%
Processing time
Initial inspections conducted within 3 months of application 59% 75%
Re-inspections conducted within 6 months of due date 54% 70%
Outcomes of inspections of overseas manufacturers
Number of inspections conducted 35 30
Satisfactory compliance (of completed inspections) 60%[a] 96%[b]
Marginal compliance (of completed inspections) 3%[a] 4%[b]
Unacceptable (of completed inspections) 3%[a] 0%[b]
Close-out in progress 34%[a] 17%
Processing time
Initial certification inspections conducted within 6 months of application 25% 50%
Certification re-inspections conducted within 6 months of due date 70% 58%
  1. Previous reports excluded inspections that had been conducted during the reporting period but had not yet been closed out. To ensure we report on all activities conducted by the TGA the report for the July to December 2015 reporting period was adjusted. The sum of percentages in this column is 100%.
  2. Compliance data for this period is aligned with data reported for the 2015-16 financial year and excludes 'Close-out in progress' in calculation of percentages i.e. the percentages reported are limited to those inspections that are completed. Analysis of historical data shows that when these inspections are completed, the percentages tend to remain consistent.

Applicants often submit applications for GMP licences and certifications before finalising all of their systems and processes. The TGA works with the applicant to ensure an inspection is not conducted before the manufacturing facility is ready, as this may result in an adverse outcome. It is therefore not uncommon for inspections to be conducted later than the target dates.

Table 17B - Devices
2015
Jul-Dec
2016
Jul-Dec
Quality Management System (QMS) Audits (domestic manufacturers)
Number of audits conducted 21 18
Satisfactory compliance (of completed audits) 47% 39%
Marginal compliance (of completed audits) 5% 22%
Unacceptable (of completed audits) 0% 0%
Close-out in progress 48% 39%
Processing time
Initial audits conducted within 3 months of application 33% 33%
Re-audits conducted within 6 months of due date 22% 27%
QMS Audits (overseas manufacturers)
Number of audits conducted 9 13
Satisfactory compliance (of completed audits) 11% 69%
Marginal compliance (of completed audits) 0% 0%
Unacceptable (of completed audits) 0% 0%
Close-out in progress 89% 31%
Processing time
Initial certification audits conducted within 6 months of application 43% 43%
Certification re-audits conducted within 6 months of due date 0% 84%

The Device Conformity Assessment Section (DCAS) receives applications for Conformity Assessment Certification and conducts assessment of these applications. It may be determined that the Quality Audits and Assessment Section is required to conduct an audit of one or more manufacturers included in the Conformity Assessment Application. The timeframes used above for calculation of conduct audits are from the date of notification from DCAS.

Table 18 Number of GMP clearance applications
2015
Jul-Dec
2016
Jul-Dec
Applications received 2,100 2,458
Applications completed
Approved 2,819 2,619
Rejected 156 166
Total completed 2,975 2,785

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

9. Laboratories

Table 19 Number of samples tested by type of therapeutic good and percentage which failed for the period July to December 2016
2015
Jul-Dec
2016
Jul-Dec
Product type Total % fail Total % fail
Prescription medicines 408 0.5% 603 1.3%
OTC medicines 30 10% 30 23.3%
Complementary medicines 54 16.7% 41 22.0%
Medical devices 63 30.2% 112 30.4%
Contract[a] 7 71.4% 14 85.7%
Unregistered[b] 165 84.2% 97 63.9%
Total samples (excluding AHQ samples) 727 24.2% 897 14.7%
Total samples[c] 983 19.8% 1,229 11.0%
Total number of products tested[d] 370 - 325 -
  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.

10. Medicine and Vaccine Adverse Event Reporting

Table 20 Source of notifications of medicine and vaccine adverse reaction
2015
Jul-Dec
2016
Jul-Dec
Reports with clear causality, by reporter
Hospitals 1,178 919
Companies 4,566 4,952
General practitioners 272 270
Specialists 101 178
Pharmacists 469 489
Members of the public (consumers) 333 493
Nurses, dentists, complementary healthcare practitioners 91 74
State/Territory Health departments 1,044 1,264
Unregistered online reporters N/A[a] 64
Reports rejected or without clear causality
443 1,165
Total received 8,497 9,868
Mean number of reports received weekly 326 379
Vaccine reports included in above table 1,302 1,637
  1. Data not reported for this period.

11. Medical device incident reports

Processing time is defined as the number of working days from receipt of the notification until the incident has been investigated and resolved.

Table 21 Number of completed medical device incident reports and processing time
2015
Jul-Dec
2016
Jul-Dec
Reports completed 1,969 2,100
Mean TGA processing time 6 7
Percentage processed within target timeframe 93% 94%

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

12. Regulatory compliance

Table 22 Number of products investigated for compliance issues by product type
2015
Jul-Dec
2016
Jul-Dec
Complementary medicines 216 225
Prescription medicines 648 1,748
Medical devices 46 46
Homoeopathic medicines 2 22
OTC medicines 17 12
Biological products 30 14
Other 31 26
Total 990 2,093
Table 23 Number of completed regulatory compliance investigations by final action taken
2015
Jul-Dec
2016
Jul-Dec
Warned[a] 353 449
No offence detected 42 20
Goods released under Personal Import Scheme 119 293
Referred to another agency or department outside Health 6 4
Referred to another Branch within the TGA 4 4
Filed for intelligence purposes 0 12
Finalised in a linked file 0 6
Import treated as abandoned goods by Customs 0 0
Recall of goods 0 1
Matters referred to the Commonwealth Director of Public Prosecutions 1 0
Total completed 525 789
  1. The category "warned" could incorporate goods being destroyed as prohibited imports, allowed to re-export goods or compliance actions against companies or individuals.
Table 24 Number of regulatory compliance investigations by offence category[a]
2016
Jul-Dec
Import 1,434
Supply 66
Claims 5
Manufacture 5
Export 2
Forgery 1
Total completed 1,513
  1. Reporting against these specific categories commenced in July 2016.

Table 24 shows the number of investigations by offence category. The correlation between tables 22 and 24 shows for example, an offense category of import could include multiple products captured in table 22.

13. Recalls

Table 25 Number of therapeutic goods recalls
2015
Jul-Dec
2016
Jul-Dec
Medicines 31 16
Medical devices (including IVDs) 291 301
Biologicals 0 2
Bloods 95 55
Total recalls 417 374

Analysis of outcomes for blood-related recalls for the previous ten reporting periods shows activity is now returning to normal levels.

Version history

1 July to 31 December 2016

Version Description of change Author Effective date
V1.0 Original publication Reporting and Collaboration Services March 2017