Introduction

On 1 July 1995, the TGA will introduce a revised process for the listing of drugs for supply in Australia on the Australian Register of Therapeutic Goods (ARTG). The new process, which was developed in consultation with industry and consumers, is aimed at maintaining the current policy settings whilst reducing turnaround times for applications to 14 days.

The solution to the development of a backlog of applications was seen as a change to the process - allowing self-assessment by sponsors against published documentation and the electronic lodgement of applications through a custom designed software package - the Electronic Lodgement Facility.

The Electronic Lodgement Facility

The Electronic Lodgement Facility (ELF), has been developed as a "smart form". It will provide both a filter and validation system as well as the carrying medium for the application data. The filter and validation system will require sponsors to select nomenclature from a series of positive lists. This differs from previous practice where the use of non-approved terminology has been a primary factor in the slow progress of many applications.

The assessment is undertaken as part of the preparation of the product listing application and submitted to the TGA on disk. The disk is accompanied by a signed certificate generated automatically as part of the listing application and, if the guidelines have been followed, the product will be computer verified and the Listing Certificate generated.

If the sponsor fulfils all the requirements of the ELF form they will be guaranteed both listing on the ARTG and a turnaround of 14 days. Following entry on the ARTG, a post-entry audit of all applications will be conducted within 14 days to confirm that eligibility requirements have been met. Failure to meet these requirements will result in the cancellation of the goods. Sponsors will be notified of the results of the audit.

The ELF software will also have regular upgrades through the year so that the sponsor will have the most up-to-date data tables available.

Each ELF package will cost $130, and will be available from 1 July 1995. This introductory price has been set to encourage industry to purchase and implement the electronic lodgement facility.

More detailed information on the Streamlined Listing Process or ELF can be found in a new TGA publication, the TGA Accelerated Drug Listing Bulletin, or at seminars run jointly by the TGA and industry through May and early June.

TGA Approved Terminology for drugs: revised edition available soon

Application for registration and listing of drug products requires sponsors to provide information about the products, such as ingredients, dosage forms, and container types, using TGA Approved Terminology.

The TGA has added, reviewed and updated many terms since the last issue of the terminology was published in January 1993. Copies of the new edition will be available in July 1995 for $120 each.