ATAGI Terms of Reference
The Australian Technical Advisory Group on Immunisation (ATAGI) provides advice to the Minister for Health on the Immunise Australia Program and other related issues. In addition to technical experts, ATAGI's membership includes a consumer and general practitioners.
The Terms of Reference of the Australian Technical Advisory Group on Immunisation are to:
- provide technical advice to the Minister for Health on the medical administration of vaccines available in Australia, including those on the National Immunisation Program
- through the department, provide advice to research funding bodies regarding the status of current immunisation research and areas where additional research is required
- advise the Pharmaceutical Benefits Advisory Committee on matters relating to the ongoing strength of evidence pertaining to existing, new and emerging vaccines in relation to their effectiveness and use in Australian populations
- produce the Australian Immunisation Handbook for the approval of the National Health and Medical Research Council
- consult with the National Immunisation Committee (NIC) on the content and format of the Australian Immunisation Handbook and associated implementation strategies
- consult with the Communicable Diseases Network Australia (CDNA) and the Advisory Committee on Vaccines (ACV) on matters relating to the implementation of immunisation policies, procedures and vaccine safety.
ATAGI Strategic Intent
ATAGI Membership and Conflicts of Interest (at January 2017)
ATAGI Working Parties
ATAGI establishes working parties and working groups (subgroups of a working party consisting mainly of ATAGI members) to examine specific vaccine preventable diseases in depth, including to review and interpret the evidence on the use of vaccines to address those diseases.
Working parties / groups are tasked with preparing evidence-based population-focussed advice and recommendations for ATAGI’s consideration in formulating advice to Department of Health and the Pharmaceutical Benefits Advisory Committee (PBAC). Advice from the working parties / groups is also used by ATAGI in formulating or revising recommendations on vaccine use in the Australian Immunisation Handbook.
Each of the working parties/groups is a chaired by an ATAGI member. Members of the working parties consist of selected members of ATAGI as well as other experts in the area of focus who are not ATAGI members. Other experts with specialised knowledge or skills may also be invited to provide specific additional information to facilitate the work of each of these working parties as required. In some instances specific pieces of work may be tasked to a sub group of the working party.
Working Party Memberships and Conflicts of Interest can be accessed below:
National Immunisation Program (NIP) vaccine listing process
PDF printable version of National Immunisation Program (NIP) vaccine listing process (PDF 84 KB)
In order for a vaccine to be supplied through the NIP, the following regulatory steps must occur:
- TGA Registration
- All vaccines must be registered by the Therapeutic Goods Administration (TGA) as clinically safe and effective for use in Australia.
- A positive TGA delegate's overview must be provided in order for the Pharmaceutical Benefits Advisory Committee (PBAC) to consider recommending a submission (refer Step 2).
- Full TGA registration is required before Government approval can be sought to fund a vaccine for a particular cohort through the NIP (refer Step 4).
- All new vaccines and extended cohorts for existing NIP vaccines must be recommended by the PBAC as clinically and cost-effective for the NIP.
- Clinical advice from ATAGI must accompany all vaccine submissions to the PBAC and submissions must address all matters raised in the ATAGI advice where appropriate (refer to information on ATAGI pre-submission advice below). For further information regarding the PBAC process please refer to the PBAC Guidelines.
- Following a positive PBAC recommendation, a price must be agreed between the Department and the pharmaceutical company.
- There will be opportunity for further price negotiations as part of the NIP vaccine procurement process (refer Step 6).
Listing on Determination
- Following full TGA registration and a positive PBAC recommendation, the Department must seek Government approval to fund a new vaccine for a particular cohort through the NIP.
- Actual purchasing arrangements are subject to the outcomes of a NIP vaccine procurement process - no vaccine is guaranteed to be purchased for supply on the NIP (refer Step 6).
- Following Government approval, a vaccine must be listed on the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No. 1) (the Determination).
- All amendments to the Determination are registered on the Federal Register of Legislation.
- Following a positive PBAC recommendation, a company is eligible to participate in a procurement process to have that vaccine purchased by the Government for supply through the NIP.
- A vaccine must be approved by Government and listed on the Determination before any contract for supply can be executed.
ATAGI advice for vaccine submissions to the Pharmaceutical Benefits Advisory Committee (PBAC)
PDF printable version of ATAGI advice for vaccine submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) (PDF 80 KB)
All vaccine submissions to the PBAC must be accompanied by clinical advice from ATAGI. This is commonly referred to as ATAGI pre-submission advice.
ATAGI Working Parties require a minimum of six months to develop pre-submission advice for ATAGI’s consideration at a face-to-face meeting. This timeframe is subject to negotiation and possible extension at the Department of Health’s (the Department’s) discretion based on ATAGI’s workload and prioritisation.
Companies are encouraged to provide the ATAGI Secretariat with as much notice as possible regarding timing for future requests. The ATAGI Secretariat can be contacted via email at ATAGI.Secretariat@health.gov.au.
- Company Request
- Companies must submit a formal request with supporting documentation to the ATAGI Secretariat at least six months prior to the ATAGI meeting where it is proposed to be considered for endorsement.
- If a company is proposing to use parallel processing arrangements, it should notify the ATAGI Secretariat at this time (refer to information on parallel processing below).
Development of advice
- Following receipt of a request, the Department will consider the request in consultation with the Chair of ATAGI, the Chair of the relevant ATAGI Working Party (where a Working Party is already established) and the technical support lead within the National Centre for Immunisation Research and Surveillance (NCIRS); and agree on timeframes for ATAGI endorsement.
- Agreed timeframes will be communicated by the ATAGI Secretariat to the company to assist in planning for a future PBAC submission.
- ATAGI advice is developed by its Working Parties, with technical support from NCIRS.
- A Working Party may need to be re-activated or created (as required) to develop the advice.
- The relevant Working Party (through the ATAGI Secretariat) will liaise with the company as required throughout the development process.
- ATAGI advice is considered for endorsement at a face-to-face meeting held in February, June and October each year.
- The final ATAGI advice is provided to the company by the ATAGI Secretariat as soon as possible following ATAGI endorsement.
Parallel processing requirements for vaccine submissions to the Pharmaceutical Benefits Advisory Committee (PBAC)
Note: the below requirements are for ATAGI’s purposes only and will not be considered as part of the PBAC submission process.
All companies are required to advise the ATAGI Secretariat of their intention to use parallel processing arrangements for vaccine submissions to the PBAC. This should be communicated at the same time that ATAGI pre-submission advice is requested.
In doing so, a company must clearly justify the reason for using parallel processing as well as timeframes for TGA registration. This will enable the Department and ATAGI to consider the company’s position when prioritising ATAGI’s workload for developing pre-submission advice.
In particular, the following issues should be considered by companies opting to use parallel processing for vaccines:
- Tender timeframes i.e. whether delaying the PBAC submission would affect a company’s ability to participate in an upcoming tender.
- The nature of the TGA application i.e. whether it is for a new vaccine or a change to the indication or dose schedule for an existing vaccine.
- The potential public health benefit of including the new vaccine (or the change in schedule and/or indication to an existing vaccine) on the NIP.
- The potential benefits of having an additional supplier of the vaccine type on the NIP to ensure security of supply.
Further information relating to parallel processing requirements for the PBAC is available on the Pharmaceutical Benefits Scheme website.
Department of Health
GPO Box 9848 - MDP 13
CANBERRA ACT 2601
Email: ATAGI Secretariat
ATAGI Bulletins and Meeting Agendas
If you require any earlier editions of the ATAGI bulletins please email ATAGI Secretariat
Email: ATAGI Secretariat