Annual Report - Performance Information

PART 2: PERFORMANCE INFORMATION

Performance Information for Departmental Outputs

Output Group 1. Policy Advice, including:

working with relevant policy areas of the Department to provide advice in relation to appropriate national policies and controls for medicines, medical devices, chemicals, gene technology, blood and tissues; and
advice in relation to collaboration with international stakeholders.

Target:	Quality: Ministers’ satisfaction with the quality, relevance and timeliness of our advice for Australian Government decision-making.
Result:	Target met.	Ministers were satisfied with the quality, relevance and timeliness of advice provided for Australian Government decision making.

Output Group 3. Agency-specific Service Delivery, including:

regulatory activity in relation to therapeutic products, through:
pre-market assessment of therapeutic products at a level appropriate to assessed risk;
assessment of manufacturers of therapeutic products to ensure compliance with Good Manufacturing Practice requirements; and
post-market surveillance and other activities based on risk management and targeted testing of therapeutic products;

Target:	Quality: Evaluations and appeals of decisions on applications for entry of products onto the Australian Register of Therapeutic Goods are made within legislated timeframes, where applicable.
Result:	Target met.	The statutory timeframes were met for all prescription medicines evaluations in 2005-06. The numbers of submissions relating to prescription medicines are shown in Table 1 at the end of this chapter.
Target:	Quality: Licensing audits and ongoing surveillance audits of Australian and overseas manufacturers are performed within target timeframes.
Result:	Target met.	All audits and applications were performed within target timeframes.
Target:	Quality: Breaches of the Therapeutic Goods Act 1989 are investigated and appropriate action taken.
Result:	Target met.	During the period 1 July 2005 to 30 June 2006, 464 new referrals breaches were received from stakeholders including members of the public, industry, local and international law enforcement and regulatory agencies with 425 investigations completed. The TGA Surveillance Unit issued 126 formal warnings to persons/companies and charged 12 persons/companies with 116 criminal offences.
Target:	Quality: Consultation with stakeholders on regulatory change in relation to therapeutic products.
Result:	Target met.	The TGA group of regulators has received feedback from a number of sources that has indicated a generally positive response to inputs to national policy, planning and strategy development and implementation. Examples include consultations with stakeholders on the proposed IVD regulations; the new framework for Human Cellular and Tissue Therapies; workflow practices within the Drug Safety and Evaluation Branch of the TGA; and the review of Australian arrangements for clinical trials and access to unapproved therapeutic goods.
Target:	Quality: 6,500–8,000 applications for registration, listing, inclusion or variation of products on the Australian Register of Therapeutic Goods processed to completion.
Result:	Target met.	7,333 applications for registration, listing or inclusion on the Australian Register of Therapeutic Goods were approved in 2005-06.
Target:	Quality: A minimum of 800 therapeutic products tested as part of post-marketing surveillance.
Result:	Target met.	TGA Laboratories tested 898 products consisting of 1,780 samples in 2005-06. In addition, TGA Laboratories completed protocol release evaluations for 551 batches of biological medicines.

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regulatory activity in relation to genetically modified organisms (GMOs), through licensing and monitoring of dealings with GMOs;

Target:	Quality: Evaluations and appeals of decisions on applications to deal with GMOs are made within legislated timeframes, where applicable.
Result:	Target met.	The OGTR received 38 licence applications for dealings involving intentional release of GMOs into the environment and dealings not involving intentional release of GMOs into the environment. The OGTR issued 22 licences to deal with GMOs. All evaluations were completed within statutory timeframes. There were no appeals against Gene Technology Regulator decisions.
Target:	Quality: Non-compliances of the Gene Technology Act 2000 are investigated and appropriate action taken.
Result:	Target met.	All breaches of the Gene Technology Act 2000 that were detected through OGTR monitoring activities or self-reported were investigated. In all instances risks to human health and safety and the environment were assessed as negligible and commensurate action was taken, including increased monitoring of certain field trial sites and increased education of licence holders.
Target:	Quality: Consultation with stakeholders on regulatory change in relation to GMOs.
Result:	Target met.	The OGTR consulted extensively with stakeholders in developing proposed technical amendments to the Gene Technology Regulations 2001 and the revision of the Regulator’s Guidelines for the Certification of Physical Containment 1 & 2 Large Scale and Physical Containment 3 Laboratory Facilities.
Target:	Quantity: A minimum of 20% of field trials inspected for compliance with conditions in licences to undertake dealings with GMOs.
Result:	Target met.	More than 20% of field trials were inspected for compliance with conditions in licences to undertake dealings with GMOs.

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regulatory activity in relation to industrial chemicals, pesticides and veterinary medicines, through:
pre-introduction assessment of new industrial chemicals and review of priority existing industrial chemicals (including environmental risk);
provision of advice on the public health impact of pesticides and veterinary medicines, which takes into account national and internationally recognised standards; and
establishment and maintenance of human health standards;

Target:	Quality: Evaluations and appeals of decisions on applications in relation to: industrial chemicals; and human health aspects of pesticides and veterinary medicines are made within legislated timeframes, where applicable.
Result:	Target met.	The timeframe target of 95% was exceeded for 202 New Chemicals assessment certificates and 120 New Chemical permits. NICNAS declared for assessment 27 Existing Chemicals and completed 11 Priority Existing Chemical and other assessments, and completed 6 hazardous assessments for international agencies exceeding the target of 13 assessments to be completed a year. There were 2 applications involving 3 appellants made to the Administrative Appeals Tribunal. These decisions remain pending. The Director of NICNAS granted confidential listings on the Australian Inventory of Chemical Substances (AICS) for 25 chemicals from a total of 33 applications received, and there are 7 pending applications with 1 listed on the public AICS. The Office of Chemical Safety met 97.5% of timeframes (target 95%) for all 9 major and 55 minor pesticide and veterinary medicine health risk assessments and 53 occupational health and safety assessments, plus 3 permits and 1 extension of use. All of these registration assessment reports were accepted by the Australian Pesticides and Veterinary Medicines Authority. For 2005-06, a total of 10 pesticide reviews were completed. Of these, 6 were completed within the agreed timeframes, partially achieving the target of 95%. 3 of the 10 completed reviews required post-assessment amendments to the health standards. The National Drugs and Poisons Scheduling Committee made 101 scheduling decisions during the year (21 agricultural and veterinary chemicals, 70 medicines and 10 chemicals). Of these, 7 were subject to post meeting comment and all but 1 were confirmed/amended (ie accepted). The Office established or amended, following review, 122 public health standards for pesticides. There were 3 amendments of the Standard for the Uniform Scheduling of Drugs and Poisons, 20th edition; 1 consolidated Standard for the Uniform Scheduling of Drugs and Poisons, 21st edition; and 3 issues of the Handbook of First Aid Instructions, Safety Directions and Warning Statements for Agricultural and Veterinary Chemicals.
Target:	Quality: Breaches of the Industrial Chemicals (Notification and Assessment) Act 1989 are investigated and appropriate action taken.
Result:	Target met.	NICNAS finalised 17 breaches relating to the introduction of new chemicals and audited 15,194 entities concerning registration requirements under the Industrial Chemicals (Notification and Assessment) Act 1989. This compliance effort resulted in remedial action by companies in order to become compliant and 1,233 new registrations.
Target:	Quality: Consultation with stakeholders on regulatory change in relation to industrial chemicals, pesticides and veterinary medicines.
Result:	Target met.	NICNAS completed public consultations on the discussion paper on a new model for the NICNAS Existing Chemicals Assessment Program.

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provision of licensing, permits and/or monitoring system for prohibited and scheduled substances under the United Nations Drug Treaty.

Target:	Quantity: 95% of permits and licences issued and reporting completed within agreed targets.
Result:	Target met.	Compliance activities for licit use of controlled substances saw 5,467 permits and 721 licences issued, all within target timeframes (97%). A total of 1.9 million domestic movements of controlled substances for licit purposes were tracked as part of the national anti-drug diversion program. Australia's compliance efforts for the calendar year 2005 were reported to the United Nations International Narcotics Control Board on 30 June 2006 as required.

Table 1: Prescription Medicines Submissions

		2004-05	2005-06
Category 1	An application to register a new prescription medicine or a change to a medicine not meeting the requirements for Category 2 or Category 3 applications.	335	366
Category 2	An application to register a prescription medicine where two independent evaluation reports from acceptable countries are available.	0	0
Category 3	An application involving changes to the quality data of medicines already included on the Australian Register of Therapeutic Goods and not involving clinical, non-clinical or bioequivalence data.	989	954

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