Regulation of vaccines
Course on the essential functions of National Regulatory Authorities (NRAs) responsible for the regulation of vaccines at the Therapeutic Goods Administration (TGA), Canberra, Australia
The Therapeutic Goods Administration (TGA) is one of the accredited training centres around the world that contributes to the WHO Global Training Network (GTN). The GTN was developed in 1996 as a means of providing educational resources to staff of vaccine production facilities and regulatory agencies responsible for control of vaccines. Training is provided by the GTN member institutions using WHO-approved curricula and standardised materials.
As a National Regulatory Authority (NRA) contributing to the GTN, the TGA is ideally positioned to provide training in the regulation of vaccines to staff of other NRAs and National Control Laboratories. TGA has developed a curriculum for a training course which covers the six critical control functions considered essential for any NRA engaged in regulation to ensure the safety, quality and efficacy of vaccines produced in, or procured for use in, the country of responsibility.
The TGA fulfils its role by providing the following functions that are defined in WHO Guidelines as essential to any National Regulatory Authority:
- A national register to catalogue therapeutic goods that may be legally sold in Australia (Australian Register of Therapeutic Goods).
- Pre-registration evaluation of manufacturing and quality control, toxicological and clinical trial data on therapeutic products proposed by manufacturers for inclusion in the Australian Register of Therapeutic Goods (Drug Safety and Evaluation Branch, TGA Laboratories Branch, Non-Prescription Medicines Branch, Office of Chemical Safety, Office of Devices, Blood and Tissues).
- A laboratory to test the quality of products on the market (TGA Laboratories Branch).
- A manufacturer assessment section that inspects manufacturing sites and licenses those that comply with good manufacturing practices (Office of Devices, Blood and Tissues).
- A means to evaluate the batch release testing performed by quality control laboratories of manufacturers (TGA Laboratories).
- A surveillance system to monitor product safety, comprised of:
- an adverse reaction reporting mechanism for drugs,
- a problem reporting mechanism for medical devices,
- a legal enforcement section, and
- a uniform procedure for recalling therapeutic products from the market.
The TGA will provide a 6 day training course for 12-16 WHO Fellows from countries that require assistance in strengthening the regulation of vaccine production or procurement. The course is to be held at the TGA in Canberra and will provide trainees with a sound understanding of the six critical control functions of National Regulatory Authorities.
The course will be conducted as interactive workshops each designed to address the six critical functions. At the conclusion of the course, a half-day interactive workshop will be devoted to planning implementation of information gained during the course. All modules will be presented in English.
The Regulatory System in participant countries
Workshop – Regulatory system in participant countries
Marketing Authorisation - System
Marketing Authorisation- Manufacture and QC issues
Marketing Authorisation – Clinical assessment
Post-market Surveillance - AEFI
Review / Revision
- The course will be held at the TGA, 136 Narrabundah Lane, Symonston, Australian Capital Territory, 2609, Australia.
- Accommodation will be arranged by the TGA and will be in shared two-bedroom serviced apartments equipped with kitchens and cooking facilities.
- Participants will be advised of the accommodation details in the acceptance letter sent by WHO.
- Participants will be required to make their own way to the hotel on arrival to Canberra.
- Transport to and from the TGA each day will be provided.
- Lunch and morning/afternoon teas will be provided for each day of the course.
For further information please contact:
PO Box 100
Woden ACT 2606
Tel: 61-2-6232 8402
Fax: 61-2-6232 8442
Dr Umit Kartoglü
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27
Tel: 41 22 791 4972
Fax: 41 22 791 4384