Review of listing of drug products

A significant advance in the process for listing drug products on the Australian Register of Therapeutic Goods was made in July 1995 with the introduction of the current streamlined co-regulatory listing process that involves both premarket assessment and postmarket review. The use of the Electronic Lodgement Facility (ELF) application form in this process has provided significant benefits to both industry and the TGA in enabling listing applications to be dealt with quickly and effectively.

Industry played a significant role in the development of the ELF system and, with the TGA, is strongly committed to the continuation of the co-regulatory approach to the listing of drug products, based on the principles of self-assessment and risk management.

Industry has also played an active role in the development and submission of suggested requirements for the improvement of ELF, these being presented to the TGA at meetings in May and November 1997. A number of changes have already been agreed and implemented, such as waiving the requirement for labels and product specifications to be submitted with the listing application, but there is recognition that more needs to be done.

In March 1998 the TGA recommended a significant redevelopment of the ELF system. As a first step it was agreed that there should be a review of the underlying policy and processes for listing drug products on the Australian Register of Therapeutic Goods.

The National Manager invited the participation of industry and consumers through the formation of a Project Advisory Committee (PAC). The role of the PAC is to oversee and have input to the review process and to ensure adequate consultation. It is also to prioritise the requirements for an agreed co-regulatory process for the listing of drug products. A TGA Project Manager has also been appointed to take responsibility for managing the project, providing practical support for the PAC, and ensuring that agreed targets are met.

The PAC has now met on four occasions with many positive suggestions coming forward. It is expected that the review will be completed before the end of this year. This will then lead to specification and development of the new ELF system commencing later this year.

Mutual Recognition Agreement signed between Australia and the European Community on medical devices & medicinal products

Seated at the table signing the MRA are:
(L to R) Sir Leon Brittan and Hon John Moore MP,
standing behind are:
Hon Alexander Downer MP and Hon Tim Fischer MP

A significant achievement has been reached with the signing of a mutual recognition agreement (MRA) on standards and conformity assessment between Australia and the European Community (EC). The MRA covers eight industry sectors of which the TGA has responsibility for the medicinal products GMP inspection and batch certification and medical devices conformity assessment. The MRA has international treaty status and will help facilitate trade between Australia and Europe by allowing the testing and certification of products to be carried out in the country of export rather than the country of destination.

The formal signing took place in Canberra on 24 June 1998. It is anticipated the agreement will come into effect on either 1 October or 1 November 1998 depending on the date of completion of the Intergovernmental Agreement between the Commonwealth and the States and Territories.

The agreement applies to therapeutic goods manufactured in Australia, New Zealand and the European Community (Belgium, Denmark, Germany, Greece, Spain, France, Ireland, Italy, Luxembourg, the Netherlands, Austria, Portugal, Finland, Sweden and the United Kingdom).

The agreement does not cover products exported to or imported from Norway, Iceland, Liechtenstein and Switzerland. These countries belong to the European Free Trade Association (EFTA). However, Australia is negotiating an MRA with these countries. When this is finalised, the MRA will cover all countries included in the European Economic Area (EEA).

Medicinal products GMP inspection and batch certification

The agreement continues the standing of GMP audits undertaken by the TGA previously attained under the Pharmaceutical Inspection Convention.

For these products, each party recognises the conclusions of inspections of manufacturers of medicinal products carried out by the relevant inspection services of the other party and the relevant manufacturing authorisations granted by the "Official Inspection Services" of the other party.

In addition, the manufacturer's certification of each batch to its specifications is recognised by the other party without a re-analysis at import. For Australian manufacturers, each batch of medicinal products exported to Europe must be accompanied by a batch certificate. Furthermore, this certificate must be retained by the importer and made available to the relevant competent authority upon request.

With respect to medicinal products covered by the legislation of one party but not the other, the manufacturing company can request, for the purpose of the MRA, an inspection be made by the locally competent inspection service.

Medical devices

Under the MRA, regulatory agencies in Europe and the TGA in Australia will accept the results of assessment procedures on medical devices carried out by designated "conformity assessment bodies" (CAB) in the other jurisdiction. In Australia, the TGA is the only CAB that has been designated. The MRA does not require harmonisation of each parties' regulatory requirements or standards. In this way, each party maintains internal standards and regulatory regime against which compliance is assessed by designated bodies located in the exporting country. There are also provisions for the TGA and regulatory authorities in Europe to jointly maintain product surveillance programs to ensure that products continue to meet the health and safety requirements. There are provisions in the MRA to challenge the competence of particular conformity assessment bodies based on outcomes of postmarket surveillance activities and for such bodies to be suspended until their competence is reestablished to the satisfaction of both parties.

For registrable devices there is an 18-month transition period to allow each party to gain confidence in the other's procedures and processes for the premarket assessment of registrable devices. During this period, the TGA will request sponsors to provide evaluation and audit reports from notified bodies with their Australian Register of Therapeutic Goods (ARTG) applications for registration.

In the past, Australian manufacturers of medical devices wishing to export their product to Europe had to obtain CE marking from a Notified Body located in Europe or from a European Notified Body with an office in Australia. Under the MRA, TGA will be able to facilitate CE marking of Australian and New Zealand manufactured medical devices.

An Australian or New Zealand manufacturer may make a "Declaration of Conformity" and legally affix the CE mark once the TGA has issued the required certifications for the product and quality system. However, before making an application the manufacturer should ensure that they have prepared technical documentation and met the quality system requirements of the Directive. Instructions for the preparation of a technical file are given in the Annexes of the Directive.

The TGA is now accepting applications from Australian manufacturers who wish to have their medical devices notified to the European regulatory requirements.

Devices incorporating animal derived tissues, radioactive materials, in vitro diagnostics and devices manufactured in other countries (even those devices that have CE marking) are excluded from the MRA provisions.

Industry seminars

The TGA in conjunction with the Department of Industry, Science and Tourism (DIST) will conduct industry seminars in all major capital cities, depending on the level of interest, when the EC visits Australia to finalise the designation of the Conformity Assessment Bodies participating in the MRA.

The TGA is currently drafting an information sheet including frequently asked questions (FAQ) on CE Marking. Also, the Department of Industry, Science and Tourism has a comprehensive information pack on the EC-Australia MRA on Conformity Assessment for the Australian business community. The information pack covers items such as an introduction on the MRA, guidelines on CE Marking, and the EU standard and conformance assessment system.