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Half-yearly performance reports - July to December 2014

31 March 2015

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Key observations: January to June 2014

Market authorisation

Prescription medicines

  • The number of submissions to register new prescription medicines, or to make significant variations to an existing prescription medicine (Category 1), has remained relatively consistent with previous periods over 2013 and 2014.
  • Category 3 submissions (variations to existing medicines that do not need to be supported by clinical, non-clinical or bioequivalence data) have remained relatively consistent with previous periods over 2013 and 2014.
  • All other submissions have remained relatively constant overall.
  • Mean processing times for Category 1 and 3 applications were well below the statutory timeframes of 255 days and 45 days respectively.

Over-the-counter (OTC) medicines

  • There was an increase in the total number of applications received compared with January-June 2014, although the number falls within the variability of previous periods. The number of N4 applications has tripled compared with January-June 2014.
  • There continues to be a high volume of applications to make quality and non-quality related changes (C1 and C2), compared to new applications.
  • Mean processing times for all types of applications were well below the agreed target timeframes. The percentage of applications completed within target timeframes was consistently higher than the 80% target.

Complementary medicines

  • There was one new registered complementary medicine application received between July and December 2014, which is equivalent to the previous reporting period.
  • The number of newly listed complementary medicines entered on the Australian Register of Therapeutic Goods between July and December 2014 is similar to the number of new entries reported in the previous reporting period of January to June 2014.
  • The total number of new listed medicines in 2014 showed a 28% increase from 2013.

Medical devices

  • In 2012, joint implants were reclassified from Class IIb to Class III. After an initial large increase in May and June 2013 (coinciding with the end of the waiver of application fees), the number of Class III joint reclassification applications received has noticeably reduced during the last three reporting periods.
  • The high number of joint reclassification applications has impacted on resource allocation for audit assessments of other applications. Therefore, timeframes for level 2 compulsory audit assessments and non-compulsory audit assessments are currently not meeting the target timeframes. However over the past 18 months, the number of outstanding application audits has gradually reduced for level 1 compulsory audit assessments and non-compulsory audit assessments.

Special access scheme for medicines

  • The number of Category A notifications for use in patients who are terminally ill or seriously ill or have life-threatening conditions have steadily increased for all types of therapeutic goods; medicines, devices and biologicals. For medicines, the total number of Category A notifications in 2014 showed a 3.7% increase from 2013 (2013:35,049 notifications; 2014: 36,346 notifications). For devices, the total number of Category A notifications in 2014 showed a 40% increase from 2013 (2013: 2,210 notifications; 2014: 3,107 notifications in 2014). Of significant note, the total number of Category A notifications for biologicals showed a 342% increase in 2014 (2013: 14 notifications; 2014: 62 notifications).
  • The number of Category B applications for use in patients other than those with terminally ill or seriously ill/life threatening conditions decreased slightly for medicines and devices, but increased significantly for biologicals. The total number of Category B applications specifically for biologicals in 2014 showed a 25% increase from 2013 (2013: 1,926 applications; 2014: 2,400 applications).

Postmarket activities

Licencing and manufacturing

  • As at 31 December 2014, there were 414 Australian companies holding manufacturing licences covering 457 sites.
  • Between July and December 2014, 97% (99 out of 102) of licence application inspections of Australian manufacturers were found to have satisfactory compliance and the remaining 3% (3 out of 102) were found to have basic compliance.
  • As at 31 December 2014, 2681 overseas manufacturers of therapeutic goods were approved to supply the Australian market. Of these, 410 overseas manufacturers covering 422 sites were approved following a TGA inspection. The remainder were approved based on inspections conducted by equivalent international regulatory authorities.
  • Between July and December 2014, 86% (41 out of 47) of certification inspections for assessment were found to have satisfactory compliance, a further 11% (5 out of 47) were found to have marginal compliance and 3% (1 out of 47) were found to be unacceptable.

Therapeutic goods recalls

  • Between 1 July and 31 December 2014, there were a total of 366 recall actions coordinated by the TGA, comprising 22 medicines, 291 medical devices (including in vitro diagnostic medical devices; IVDs), and 53 process-related blood product recall actions.
  • The average numbers of recall actions for a six month period over the last three years were: 26 (medicines), 284 (medical devices including IVDs), 1 (biological) and 46 (blood products).

Medicine and vaccine adverse event reports

Reporting of medicine and vaccine adverse events peaked in 2013 with over 20,000 adverse event case reports received and remains above 17,000 reports being received annually. Hospital adverse event reports increased in the second half of 2014 by 28% compared to the previous year. The reason for the fluctuation is usually due to normal variation that can occur in a spontaneous reporting system. In this case it is also likely that changes in reporting requirements for sponsors regarding reporting of adverse events associated with patient support programs would have reduced the number of reports from sponsors. These reports are now considered solicited and are not required to be reported (this is also the case in the European Union).

Regulatory compliance

  • Between July and December 2014, we dealt with 576 alleged offences. The types of investigations included illegal import, supply, manufacture, claim and export. None of these offences required resolutions through the court system and therefore there were no convictions, however, one enforceable undertaking was entered into during this period as an alternative to court action. Please see Enforceable undertaking: Nutrition Warehouse Pty Limited.

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