Global Harmonization Task Force Conference to be held in Singapore

The 9th Global Harmonization Task Force conference is to be held in Singapore on 12-16 May 2002.

The conference features an exciting and interactive program, not only for regulators, but also for manufacturers of medical devices and other organisations interested in their quality, safety and clinical performance.

It promises to provide participants with an overview of the latest global regulatory requirements for medical devices as well as an insight into future developments.

The program will include sessions on the global regulatory model, new emerging technologies, the total product life cycle with particular emphasis on postmarket surveillance and vigilance as well as regional regulatory updates.

The GHTF comprises five founding members - Canada, the USA, European Union member states, Australia and Japan - with the chair rotating among these members. In January 2001, the Chair moved from North America to the Asia-Pacific for three years, with Australia assuming the Chair in the first 18 months to be followed by Japan.

Australia is represented by Mr Terry Slater (Therapeutic Goods Administration National Manager) and Ms Rita Maclachlan (Director, TGA Conformity Assessment Branch and GHTF Chair) on the GHTF Steering Committee. Mr Brian Vale, Chief Executive Officer of the Medical Industry Association of Australia, is the GHTF's Vice-Chair.

Registration forms are now available and the TGA would like to encourage Australian stakeholders with an interest in the medical devices industry to attend.

The aim of the GHTF is to encourage convergence in regulatory practices relating to the protection of public health, promote technological innovation and facilitate international trade.

It provides a forum for the world's regulatory agencies, working with medical device manufacturers and other organisations possessing relevant expertise, to develop global approaches to regulating the quality, safety and clinical performance of medical devices.

Conference details

The 9th GHTF Conference will be held from 12-16 May 2002. It will be followed immediately by the GHTF Medical Devices Training Seminar - sponsored by the Asia Pacific Economic Cooperation forum, on 17-18 May 2002. Both events will be held at Singapore's Novotel Apollo Hotel.

The conference program includes:

• Four plenary sessions on
  • GHTF Business (including presentation of the GHTF Annual Report and Strategic Plan for 2002-2007)
  • New and Emerging Technologies
  • The Global Regulatory Model
  • The Total Product Life Cycle: A Focus on Postmarket Surveillance and Vigilance;
• Meetings of the four GHTF Study Groups, focusing on device classification and pre-market regulatory requirements, post-market surveillance reporting, quality systems and auditing procedures;
• The 4th meeting of the GHTF Steering Committee;
• Regional Group information sessions on new and emerging regulatory systems, including the Asian Harmonization Working Party, Latin American Session, and a Chinese Information Session;
• Concurrent Workshop sessions on
  • The Global Medical Devices Nomenclature (GMDN)
  • Evaluation of the draft World Health Organization (WHO) Guidelines for the Development of Medical Device Regulations; and
  • The Regulation and Supply of Refurbished Medical Devices.

New Parliamentary Secretary

The TGA is pleased to welcome back The Hon Trish Worth MP, Member for Adelaide, as our Parliamentary Secretary.

Ms Worth, a former nurse and midwife, joins Senator the Hon. Kay Patterson and The Hon Kevin Andrews MP to make up the Government's parliamentary health team.

Her current responsibilities include therapeutic goods, gene technology, food, alcohol, tobacco and illicit drugs, Health Services Australia and the Commonwealth Rehabilitation Service.

Patricia Mary Worth was born on 21 April 1946 in Riverton, South Australia. Ms Worth was educated at Riverton High School and Cabra College, and completed her education at Calvary Hospital in Adelaide, where she became a registered nurse and midwife. In 1967, at the age of 21, she became the Nurse of the Year and State Gold Medallist. After moving up through various senior nursing positions covering the full range of hospital care, Ms Worth took up the private sector role of Patient Services Manager, Pathology, in 1989 - a position she held for the next four years.

It was at that stage that her career took an interesting turn. In 1993 she won the seat of Adelaide, and in the elections of 1996, 1998 and 2001, retained the seat. In 1996, Ms Worth became the first female Government Whip in the House of Representatives.

From July 1997 to October 1998, Ms Worth was the Parliamentary Secretary to the Minister for Health and Family Services, responsible for the TGA, amongst other areas. Ms Worth then became Parliamentary Secretary to the Minister for Education, Training and Youth Affairs until November 2001.

"I am excited to have portfolio responsibilities within the Health area again, and in particular to again be involved with the Therapeutic Goods Administration," said Ms Worth. "The TGA performs a vital, though often unheralded, role within Australia's health system. I look forward to again working with the TGA in promoting and protecting Australians' health."

Medicines for paediatric use

The Therapeutic Goods Administration (TGA) has a number of mechanisms in place to encourage sponsors to register medicines for use in children. The TGA and the Australian Pharmaceutical Manufacturers Association (APMA) are concerned that not all sponsors are aware of these mechanisms.

There is a recognised global problem with the availability of paediatric-specific formulations and a lack of information from proper investigations of the use of drugs in children. This problem leads to drugs being used outside of their approved indications, and, at times, being reformulated by pharmacists to make them more suitable for use by children. However, the basic precept that children should not be discriminated against by being supplied poorly investigated drugs has been accepted internationally.

The lack of medicines registered for paediatric use has adverse consequences on the provision of paediatric services in general. Since products cannot be subsidised under the Pharmaceutical Benefits Scheme (PBS) for unapproved indications, this situation also places financial pressure on paediatric hospitals and the parents and families of paediatric patients.

It is a requirement under the Therapeutic Goods Act 1989 that products to be imported into, supplied in, or exported from Australia be included in the Australian Register of Therapeutic Goods (ARTG). In order for a product to be included in the ARTG, a sponsoring company is required to make an application to have the product included for a particular use (indication). The TGA cannot compel a sponsor to submit an application, but would strongly encourage sponsors with paediatric data and products to do so.

The TGA makes a scientific assessment of the data submitted in terms of quality, safety and efficacy and consults with a group of independent experts, the Australian Drug Evaluation Committee (ADEC), before deciding whether or not to approve a product for a particular indication.

Currently, the TGA has a number of mechanisms in place to encourage the submission of paediatric data packages, including:

• significant fee reductions for products that are not commercially viable or whose supply is in the public interest;
• the Orphan Drug Program, which waives all fees and offers a priority review for drugs used in conditions with a prevalence of intended users of less than 2000 per year; and
• modified literature-based submissions to facilitate submission of modified packages based on existing published data.

The TGA has also adopted internationally recognised ICH/European guidelines dealing with paediatric data generation and facilitating the extrapolation of data from one patient population to another. These can be found on the TGA website.

Sponsors are encouraged to consider whether their products are likely to be used in children, and if so, to discuss with the TGA how to make available paediatric formulations and to update the product information document with information on paediatric use.