Mr Murphy asked the Minister representing the Minister for Health and Ageing, upon notice, on 26 June 2003:

(1) Is the Therapeutic Goods Administration (TGA) required to cover its operating costs entirely from the licence, inspection and registration fees it charges.

(2) Is it the case that the TGA compliance branch employs only 11 auditors nationally; if not, (a) how many does it employ, and (b) does the TGA propose to increase that number.

(3) Is the TGA compliance branch well behind in its audit program; if so, (a) how far behind is the TGA in its audit program, and (b) does this leave open the possibility of further manufacturing standard failures as recently experienced with Pan Pharmaceuticals; if not, why not.

(4) Has the delay in the audit program been exacerbated by the adoption in August 2002 of a new industry code of practice requiring a longer audit process; if so, has the TGA received additional resources to allow it to administer the new code and, if it has not, why not.

(5) How quickly is the TGA responding to manufacturers' replies to audit reports.

Mr Andrews (Minister for Ageing) —The Minister for Health and Ageing has provided the following answer to the honourable member's question:

(1) Since the 1998-1999 financial year, the Therapeutic Goods Administration (TGA) has been a full cost recovery agency for all activities that fall within the scope of the Therapeutic Goods Act 1989. This includes regulation of the therapeutic goods industry, the TGA's public health responsibilities, the provision of information to consumers and TGA's support for industry generally (ie. facilitation of exports and international harmonisation of standards).

(2) (a) and (b) The TGA has an auditor pool of 44 officers, comprising fourteen (14) lead quality systems auditors and thirty (30) technical specialists to carry out audits of manufacturers of therapeutic goods supplied in Australia.

(3) (a) & (b) The TGA audit schedule is drawn up annually based upon manufacturer risk assessment and the available resources. At this stage the TGA has completed 41 per cent of audits of Australian and overseas manufacturers included on the 2003 schedule. It is expected the program will be satisfactorily completed with the engagement of the additional resources envisaged in (2) above.

· type of products manufactured;

· results of previous Good Manufacturing Practice (GMP) audit;

· significant changes within the company, eg changes to key personnel, building, equipment or products;

· adverse medicine reaction reports, medicine problem reports and device incident reports;

· results of TGA Laboratories testing of random or targeted samples of products;

· recalls of products not meeting safety and /or quality standards;

· information from other agencies; and

· post-licensing surveillance investigations.

(4) The content and principles of the Australian Code of GMP for Medicinal Products (August 2002) are very similar to the previous Australian Code of GMP for Medicinal Products (1990) other than for two additional requirements relating to marketing authorisation. These additional provisions require auditors to check that the product formulation matches that registered/listed with the TGA and that manufacturers validate their manufacturing and analytical processes and procedures.

(5) The TGA has maintained its usual standard operating procedure approach of responding within a target time frame of one month to manufacturers' replies to audit reports. There has not been an increase in target time in the last ten years.