Australian influenza vaccine for 1999 winter

The Australian Influenza Vaccine Committee (AIVC) meeting was held on 7 October 1998, in order to select virus strains for the manufacture of Influenza Vaccine for 1999 Season.

Having considered the information on international surveillance by WHO and up-to-date epidemiology and strains characterisation presented by Australia, New Zealand, and South Africa at the meeting the Committee considered that the WHO recommendations on the composition of vaccines for 1999 Season should be followed:

• A (H3N2): an A/Sydney/5/97 (H3N2) -like strain, 15 µg HA per dose.
• A (H1N1): an A/Beijing/262/95 (H1N1)- like strain, 15 µg HA per dose.
• B a B/Beijing/184/93- like strain, 15 µg HA per dose.

It was also determined that the following viruses are suitable vaccine strains:

• IVR-108 and RESVIR-13 are A/Sydney/5/97 (H3N2)-like strains
• X-127 is accepted as an A/Beijing/262/95 (H1N1)-like strain
• B/Harbin/7/94 is accepted as a B/Beijing/184/93-like strain.

Changes to sterility test regulations

On December 1 1998 the TGA adopted the BP 1998. At the same time the long standing TGO 11 Standard for Sterile Therapeutic Goods was revoked and replaced by Therapeutic Goods Order Number 63 for medical devices. TGO 63 determines that the BP/EP 98 sterility test "shall constitute the standard for therapeutic devices that are labelled as sterile or sterilised or otherwise purport to be sterile or sterilised".

The TGA Guidelines on Sterility Testing of Therapeutic Goods <http://www.tga.gov.au/docs/html/sterilit.htm> can be accessed on the TGA Website. A printed version is also available from the TGA Publications Office (ph: 1800 020 653).

Sponsors of sterile products should note that it is not necessary to notify the TGA of a change from the TGO 11/Appendix C sterility test to the BP/EP 98 sterility test. It is considered to be a self-assessable change. However, an application to vary the conditions of registration would be required if changes to a sterility test method other than the EP/BP 98 method were proposed.

In circumstances where molecular typing of organisms is necessary in association with sterility testing, it is recognised that some manufacturers may not have the facilities to carry this out "in house" and may elect to refer the identification to an external laboratory. The TGA has determined that it is not necessary at this stage for laboratories performing such identifications to be GMP licensed but manufacturers must ensure that external laboratories are adequately equipped to undertake the work contracted to them.

Joint Industry - TGA workshop on herbal identification and analysis

Earlier this year a joint TGA- Industry (NFAA, PMAA) Herbal Task Force was established at the request of the NFAA following TGA's reporting of problems associated with the analysis of herbal medicines. The Task Force membership includes sponsors, manufacturers, herb growers, herbal practitioners and officers of the TGA. In addition, the task force includes herbal experts from the NSW Botanic Gardens, the University of Sydney and the Southern Cross University. The group meets on a semi-regular basis to discuss technical issues relating to herbal medicines. To promote a better awareness of the requirements for herbal analysis, the Task Force recently organised a workshop entitled "Herbal Identification". The 2-day workshop was held in the Pharmacy Department of Sydney University and was attended by 36 participants drawn mainly from manufacturing companies in Australia and one from New Zealand. The workshop was a mix of theory and practice with attendees gaining 'hands-on' experience in microscopic and chemical methods of analysis. The presenters were drawn from the local and overseas industry as well as from the TGA. Feedback has been positive with the suggestion that additional training workshops could be of value.

Official Medicines Control Laboratories meeting

Dr Elaine Walker, Director of TGA Laboratories Branch (TGAL) recently attended the 3rd Annual Seminar of the European Network of Official Medicines Control Laboratories (OMCL) at the Agence du Medicament Laboratory in Montpellier, France. The meeting was attended by 75 directors of National Control Laboratories from 24 European nations, Australia and Canada.

The network has met for several years, first informally and more recently in 3 annual meetings coordinated by the European Department for the Quality of Medicines. In his opening address Professor Janot, head of the French OMCL, spoke of a need for improved information exchange, harmonised sampling procedures, and mechanisms to follow up on testing failures.

Annual reports were presented from laboratories performing post-market monitoring of pharmaceuticals, biologicals and devices for human and veterinary use and discussions were held on method development, quality assurance and laboratory accreditation, ways to exchange information and expertise, joint market surveillance studies and programs for the detection of counterfeiting. Most laboratories reported testing only for prescription chemicals though some are establishing methods to detect prohibited steroids and microbial contamination in complementary medicines. Only a few laboratories reported device testing but many spend significant resources in testing ad hoc drug samples prepared by pharmacies, a practice rare in Australia. In this area, extensive problems were being detected.

The careful targeting of TGAL's sampling program to problem areas identified by GMPALS, Surveillance, complaints from consumers, pre-market evaluation and company and product history and the resultant high detection rate for product defects were of particular interest to delegates. Several spoke of detecting problems in their own markets by follow-up of TGA's findings. The highly specialised expertise of TGAL staff and the close links between pre-market evaluation and postmarket monitoring were also of interest to other directors. In several countries, communication between testing laboratories and product licensing and registration agencies is limited.

Lengthy discussions on results of several joint market surveillance surveys revealed that the registered specifications and testing methods for a single product often differ from country to country. Most European laboratories are establishing quality systems and seeking national accreditation and a Mutual Joint Visit program between European OMCLs is assisting in this process. TGA Laboratories are accredited by the National Association of Testing Authorities Australia (NATA).

The meeting provided a valuable opportunity for exchange of information between laboratory directors and the presence of Australia and Canada is valued by the European delegates.

Review of TGA Laboratories branch

A review has been set up to examine the operations of the TGA Laboratories Branch. In announcing the review, the National Manager, Mr Terry Slater stated that:

"The TGA Laboratories Branch makes an important contribution to the work of the TGA in administering the Therapeutic Goods Act 1989. Inevitably changes in the way business is conducted in other Branches impacts on the Laboratories Branch and it is time to look at the operations of this Branch to ensure it is well placed to meet the future needs of the TGA. It is timely therefore that we undertake a review of the Branch and its operations."

The report is expected early in 1999.

Trans Tasman harmonisation - common form for reporting medical device incidents

TGA and the New Zealand Ministry of Health (MOH) are exploring a phased approach to the development of complementary regulatory arrangements across the Tasman. The Trans-Tasman Mutual Recognition Agreement (TTMRA) is intended to facilitate trade and workforce mobility between Australia and New Zealand. Therapeutic Goods have been granted a temporary exemption for twelve months under the TTMRA. As part of the Trans Tasman cooperation program, the two agencies are exploring the establishment of a joint register for therapeutic goods. These cooperative activities have a strong basis on historical collaborations between the two agencies. For instance, the regulatory requirements and postmarket monitoring of condoms are currently being aligned.

Recently, a common form has been adopted for the reporting of medical device incidents. The forms are used by medical device users to report incidents in order to initiate the investigation of problems associated with the use of medical devices. The form features the logos of both organisations and the user is directed to send in the report to the agency in their country of origin.

The two agencies already exchange information regarding Safety Alerts and Recalls. Common reporting forms will further facilitate the exchange of information between the two agencies. There are plans to adopt common sponsor questionnaires. These questionnaires are sent out to medical device sponsors on receipt of an incident report.

The new forms are available at the TGA Website (Reporting problems with medical devices <http://www.tga.gov.au/problem/index.htm#devices>), by e-mail request to iris@tga.gov.au, or by calling the Medical Device Incident Report Investigation Scheme toll free number: 1800 809 361. Older style forms will continue to be accepted until they are phased out.