Australian influenza vaccines for the 2001 winter

The Australian Influenza Vaccine Committee (AIVC) met on 25 October 2000 at the TGA (SA and NZ representatives participated via teleconference) to recommend suitable vaccine strains for the influenza vaccine for the 2001 Southern Hemisphere season. The AIVC accepted the WHO recommendations. The strains for the 2001 season are as follows:

• The A/New Caledonia/20/99 (IVR-116) was recommended as an A/New Caledonia/20/99 (H1N1)-like strain
• The A/Panama/2007/99 was recommended as an A/Moscow/10/99 (H3N2)-like strain
• The B/Johannesburg/5/99 was recommended as the B/Sichuan/379/99-like strain.

The B/Victoria/504/99 was also recommended as the B/Sichuan/379/99-like strain for vaccine production on 9 November.

The AIVC decision to recommend an alternative strain was taken to give manufacturers flexibility in maximising yield in the production of the vaccine. The Committee emphasised that the decision related solely to production yield considerations and that in terms of antigenicity and effectiveness, the two strains should be regarded as equivalent. Any promotion which seeks to claim advantage of one strain over the other will be inappropriate and sponsors are asked to ensure that this does not occur.

Implementation of the export review workprogram

There have been considerable achievements made by this project including:

• the introduction of a new Certificate of Listed Product (CLP) for listed medicines approved for supply in Australia;
• the use of a modified Certificate of Pharmaceutical Product (CPP) for registered and 'Solely for Export" goods which includes codified statements that provide advice about the circumstances of the product;
• the publication of a leaflet for distribution to regulators in export destinations explaining the TGA's new certification processes; and
• the replacement of the Prior Informed Consent process with a new Export Advisory Procedure that provides for the notification of the TGA concerns on the 'Solely for Export' Listing Certificate and CPP.

NRL workshop on serology

Serology & Technology
"where have we been . . . where are we going?"

The 18th NRL Workshop on Serology will be held on 24-26 August 2001 in Sydney, NSW, Australia. This is an annual event directed towards scientists, laboratory managers, manufacturers/distributors, regulators, pathologists, clinicians and others involved in serology. It provides a forum for national and international groups to discuss and resolve many of the important issues facing serologists today.

For more information on this Workshop visit the NRL website <http://www.nrl.gov.au> or contact:

Workshop Secretariat
National Serology Reference Laboratory
4th Floor Healy Building
41 Victoria Parade
Fitzroy VIC 3065
AUSTRALIA
Tel: +61 3 9418 1111
Fax: +61 3 9418 1155

TGA open day

As part of the Australian Science Festival 2001, the TGA will be holding an Open Day on Saturday 5 May 2001 from 10am to 4pm at 136 Narrabundah Lane, Symonston ACT. Admission is free and there is ample free parking.

There will be displays concerning premarket and postmarket aspects of the regulation of medicines and medical devices.

Tours of the laboratories will commence every hour starting from 10am. The last tour starts at 3pm.