Australian assumes the Chair of the Global Harmonization Task Force (GHTF)

In the final issue of the Australian Therapeutic Device Bulletin, readers were advised that from January 2001, the GHTF Chair would rotate to Australia for the next 18 months (with Australia providing the Chair and Secretariat support during this period).

At its 8th Conference in September 2000, the GHTF agreed to establish a Steering Committee, responsible for management oversight and policy setting for the organisation. The new GHTF Chair, Mrs Rita Maclachlan (Director of TGA's Conformity Assessment Branch), hosted the inaugural meeting of the GHTF Steering Committee in Sydney from 28 February - 2 March 2001.

During the meeting, the major issues considered by the Steering Committee were:

• A Strategic Review of the organisation and development of a Strategic Plan for the next 5 years;
• The review of several GHTF regulatory guidance documents developed by the GHTF Study Groups;
• Founding Members' progress reports on the adoption of GHTF guidance documents into their national systems for medical devices; and
• Planning for the 9th GHTF Conference to be hosted by Australia in Barcelona, Spain, from 11-16 October 2001.

Senator Grant Tambling, Parliamentary Secretary to the Minister for Health and Aged Care, addressed the Steering Committee. Senator Tambling's responsibilities include the regulation of medical devices, medicines and food in Australia. During his address to the meeting, Senator Tambling gave the commitment that the Australian Government is 'locked into' the GHTF processes and is very keen to have worldwide regulatory differences identified in order to minimise duplication of effort and resources.

The Steering Committee will progress the outcomes achieved in Sydney at its second meeting in Brussels, Belgium, scheduled for 12-13 June 2001.

Further information on the GHTF may be obtained from the GHTF website <http://www.ghtf.org>.

GHTF Study Group 1: International harmonisation in regulatory systems

The objective of the Global Harmonization Task Force (GHTF) is to encourage international harmonisation in regulatory systems. The role of Study Group 1 (SG1) is to develop harmonised documentation to assist in the premarket phase of product development to allow the demonstration of conformity assessment to the essential principles of safety and performance.

Australia is represented on SG1 by Johan Brinch of Cochlear Ltd, representing the Medical Industries Association of Australia, and Mike Flood of the Conformity Assessment Branch of the TGA.

To date, SG1 has published three final documents:

• Essential Principles of Safety and Performance of Medical Devices
• Role of Standards in the Assessment of Medical Devices
• Labelling for Medical Devices

A further document detailing recommendations on medical devices classification is in the final stages of development, and two further documents are currently in draft form:

• Information Document Concerning the Definition of the Term Medical Device
• Summary Technical File for Premarket Documentation of Conformity With Requirements for Medical Devices

Of particular interest is the Summary Technical File document (STED). In 2001, a number of the participating countries in the GHTF will be undertaking a pilot study to evaluate the utility of the STED document as the basis for developing a regulatory submission for new products. Further details of the pilot study in Australia <http://www.tga.gov.au/docs/html/tganews/news35/dev.htm#pilot> are included in this issue of TGA News.

At recent meetings of SG1, work has commenced on reviewing all documents, with a view to expanding their scope to include In-vitro Diagnostics. In their early stages, these drafts are not yet ready for public comment, but will be published on the web site when further developed, and comment sought.

The Study group is actively seeking comment on documents currently under development. Copies of all documents can be found on the GHTF website <http://www.ghtf.org>. Comments should be passed to the Australian representatives on the study group.

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GHTF Study Group 2: Towards global adverse event reporting II

The activities of Study Group 2 (SG2) of GHTF have been the subject of a previous TGA News article (Issue 31 <http://www.tga.gov.au/docs/html/tganews/news31/tganews.htm>, January 2000, pp16-17). That article presented a summary of the SG2 keystone document N21: Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorised Representative, the status of the debate on reporting of user errors, and the SG2 pilot on exchange of vigilance reports. At the time that the article was published, SG2 was planning to focus attention on developing harmonised proposals for timeframes for submission of manufacturer adverse event reports, a globally harmonised dataset for manufacturer reports as well as guidance on problem report trending to assist manufacturers with exemption clauses of N21.

Vigilance exchange pilot successful

The pilot phase of the vigilance exchange pilot is now over and the group has concluded that the exchange exercise has been extremely useful. The experience gained during the exercise has been used in the development of a guidance to assist National Regulators who wish to participate in the program. The document stipulates how to make a decision as to whether to exchange information regarding an issue and how that information is to be sent and handled. This document is considered to be Final Draft and has been placed on the GHTF website <http://www.ghtf.org> for public comment before it is presented to the Task Force for final endorsement. Participants of GHTF's SG2 continue to exchange information in accordance to the rules developed for the pilot.

Guidance on adverse event report trending

Certain adverse event reports are exempt from reporting provided they are a recognised and accepted complication associated with the use of the device. The exemption is void if a change in trend occurs in the frequency or nature of adverse event reports. SG2 has developed guidance, aimed at manufacturers, to assist them in making a decision on whether to report under these circumstances. This document has also been released for public comment.

Universal dataset on final stages of committee draft

The universal dataset for the reporting of problems to National Competent Authorities by manufacturers is in its final stages of completion. The group has reached consensus and the document will soon be presented to the GHTF Steering Committee for endorsement. Once this has been done, the document will be placed in the GHTF web site for public comment before it is adopted, by a vote at a plenary session of the GHTF, as a final GHTF document. (This is now standard procedure for adoption of GHTF documents).

Debate on global reporting timeframes

As reported in our earlier article, the Group is in general agreement that the maximum timeframe for reporting of adverse events by the manufacturer or representative to the NCA should be 30 calendar days. Study Group research and experience suggests that manufacturers are able to complete a large majority of investigations into adverse events within this timeframe. However, there are certain types of incidents where the NCA should be notified of issues or adverse events in a much shorter timeframe. SG2 is currently debating what sorts of problems should be reported within the shorter timeframe and what that timeframe should be.

Some at the group argue that a distinction should be made between events that led to death or serious injury and near events. Near events can be reported within 30 days, death and serious injury events, they argue, should be reported within a shorter timeframe (10-15 days).

The major opposition to this view holds that it is not what happened, but rather what could happen, that should determine whether an urgent report to the NCA is need. That is, it is the manufacturer's risk assessment that determines the urgency of the report. In this scheme, a patient's death may be investigated and reported within 30 days because the risk analysis revealed that the likelihood of the same event occurring again is very low, or that the event is one that is generally regarded to be an accepted risk of using the device. This may occur, for example, with highly invasive, high-risk clinical procedures. Conversely, a series of "near events" may warrant prompt and immediate action (and an urgent report to the NCA) if the risk analysis revealed that the frequency or the severity of the possible clinical outcomes, or both, is likely to be high and unacceptable. This group also argues that 10-15 days is much too long a timeframe for reporting of this type of event.

The debate on reporting timeframes continues and will hopefully be resolved during the next meeting of the Group in Paris 20-23 June, 2001.

TGA activities to implement GHTF recommendations on vigilance requirements

The GHTF recommendations on vigilance are being used in the drafting of the new Therapeutic Goods Act Amendment Bill, the new regulations and guidance documents. Where a final GHTF document is not available, the TGA has tried to predict the general intent and direction of GHTF with the view to making minor changes later, if necessary, as final GHTF documents become available. The recommendations of GHTF document N21 are currently being drafted into a guidance document on post-market procedures.

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Official Medicines Control Laboratories meeting

Dr Joe Smith of the TGA Laboratories (TGAL) attended the annual meeting of the Official Medicines Control Laboratories (OMCL), in Uppsala, Sweden, between 23-27 April 2001. The OMCL network was established in 1994 and is a key forum for achieving a coordinated and consistent approach to regulatory testing of medicines. The network consists of directors, chemist and biologists from official Medicines Control Laboratories and representatives from national licensing authorities, national inspection authorities and the European Pharmacopoeia.

These meetings are an excellent opportunity to share information with other Medicines Control Laboratories. The OMCL agenda is particularly relevant to the TGA's activities and specifically the role of the TGAL. Because of the close links between the regulation of therapeutic goods in Europe and Australia, TGAL participates in a range of OMCL collaborative testing and standard-setting activities.

Quality assessment of chinese herbal medicine

Dr Larry Kelly of the TGA Laboratories presented a lecture on the analysis of herbal medicines at the Symposium of Quality Assessment of Chinese Herbal Medicine in China during February 2001. Over 400 delegates attended the Symposium.

Presentations from both academic and government laboratories showed a high level of technical expertise and that many laboratories are using sophisticated analytical methods and equipment. The Chinese State Drug Administration (SDA) focussed on a program called 'The Modernization of TCMs' of which a central element is chemical fingerprinting for quality control. The SDA also announced that they would soon enact new medicines legislation. Part of this new legislation will require manufacturers to comply with relevant quality standards for TCM's, including fingerprinting of herbals for quality control purposes.

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International meetings

Dr Albert Farrugia attended the 67th Meeting of the expert Group 6B - Blood and Blood Products - of the European Pharmacopoeia Commission held in Strasbourg, France, 27-28 March 2001. The TGA has observer status on the Group that formulates the relevant monographs and standards applicable to plasma products for the European Pharmacopoeia.

Dr Gary Grohmann attended the WHO Annual Consultation Meeting to decide the composition of the Influenza vaccine for the Northern Hemisphere, held in Geneva, 12-14 February 2001.

Ms Vivienne Christ represented the interests of the TGA at the meeting of the European Pharmacopoeia Group of Experts No.1 for microbiological issues, held in Strasbourg, France, 15-16 March 2001.

Ms Christ also represented the TGA at the meeting of Working Group 2 - Radiation Sterilization of ISO/TC 198 Sterilization of Healthcare products, in Avignon, France, 21-23 March 2001.

Dr Jorge Garcia represented the the TGA at the Global Harmonization Task Force Study Group 2 Meeting in Los Angeles and San Francisco, 20-23 February 2001.

International training

GMP training for Hong Kong

As requested by the Pharmaceutical Service Headquarters of the Hong Kong Department of Health, a TGA senior GMP auditor, Ms Carolyn Woodruff, conducted a training program on GMP between 7-15 May 2001 in Hong Kong. As well as in-house training, the program also included activities on sites of several pharmaceutical manufactures. GMP inspection of medical gas manufacture was the key component of this training program. The program was conducted on a cost recovery basis.

Surveillance training for Thai FDA officers

Under the Plan of Action on health cooperation between the governments of Australia and Thailand, the TGA has been requested to provide technical assistance for the Thai Food and Drug Administration (FDA) on therapeutic goods surveillance and law enforcement. Between 7-18 May 2001, two Thai FDA senior officers were invited to join the TGA surveillance training program for a week. During the second week of the program, the visitors were provided with extensive practical training in Canberra and Sydney. The Department of Health and Aged Care provided funds to support the activities provided by the TGA.

Activity under the APEC support program

Between 5-25 May 2001, three senior pharmacists from the Drug Administration of Vietnam (DAV) attended a training program on GMP in Sydney and Canberra. This program is the last activity of an AusAID project supported under the APEC Support Program. Other aspects of the project provided to the DAV last year included technical assistance on the legal aspects of therapeutic goods regulation in Australia and management of adverse drug reactions.