Australian and Singapore join forces

A launch on 18 June 2003 at Parliament House, Canberra, announced the recognition by the Health Sciences Authority (HSA), Singapore, of evaluations by the TGA that will significantly speed up the process of getting new prescription medicines approved in Australia onto the Singapore market.

From left: Terry Slater, National Manager, TGA,
Desmond Koh, Deputy Chief of Mission, Singapore High Commission,
the Hon Trish Worth MP, Dr Clarence Tan, CEO, HSA Singapore,
Kieran Schneemann, CEO, Medicines Australia

The Hon Trish Worth MP, Parliamentary Secretary to the Minister for Health and Ageing, with responsibility for the regulation of therapeutic goods, said both Regulators had much to offer each other by these new arrangements.

"Singapore already has a rigorous evaluation process for approving new drugs for distribution on its domestic market, but it feels enough confidence in Australia's evaluation and approval processes to accept products from manufacturers who have already been through the stringent process of gaining Australia's stamp of approval," Ms Worth said.

"This is of benefit to people in Singapore who will see new drugs on the market much quicker. Australian manufacturers will also reap the benefits of a less time-consuming process. This is a winning arrangement for both countries."

Ms Worth said forging close links with overseas regulatory agencies was both sensible and necessary in a global economy.

"What we are acknowledging today is a cooperative arrangement that will bring our agencies closer together," Ms Worth said. "In 2000, the TGA entered into a reciprocal agreement with the US Food and Drug Administration (FDA) to exchange information on each other's decisions on Good Manufacturing Practice inspections of pharmaceutical manufacturers, recalls, adverse product trends, health hazard evaluations and alert system information.

"This was the first time the FDA signed a Memorandum of Understanding to accept results of factory inspections by a foreign regulator.

"In 2001, the TGA entered into a Mutual Recognition Agreement on Medicine Good Manufacturing Practice with Singapore's HSA. Australia and Singapore now also accept each other's decisions in this important area.

"Now we have this recognition of Australia's approval of prescription medicines by Singapore, which is another important phase towards harmonisation between countries."

Ms Worth said this strong regulatory alliance between Singapore and Australia is not only good for Singapore's health system, but offers protection from counterfeit goods and the dumping of inferior products on each other's shores.

"It also offers the prospect that our countries will have access to the latest products which have been assessed for safety and quality to current world's best regulatory standards, and are reinforced in the marketplace in line with post market regulatory best practice," Ms Worth said. "It will encourage trade between our region and the rest of the world as a result of the quality of our regulatory stamp of approval."

Ms Worth welcomed the participation of the Australian pharmaceutical companies' peak group, Medicines Australia, as party to the signing ceremony.

"This is a vital partnership between the Therapeutic Goods Administration and the Health Sciences Authority in Singapore, which will enhance the status of the TGA as one of the world's top five regulatory agencies," said the Chief Executive of Medicines Australia, Kieran Schneemann.

It is anticipated that if a company wants to market a prescription medicine in Singapore that is already available in Australia, the company will notify the HSA in their application that the product is available in Australia. The HSA will then contact the TGA to obtain a copy of the evaluation report. The TGA will seek the authorisation of the sponsor prior to releasing the evaluation report. For further information, please contact 02 6232 8131.

International training and visitors

As a major initiative to provide training programs for staff of government agencies around the region, the TGA developed an International Training Calendar <http://www.tga.gov.au/international/inttrain.htm>. The Calendar contains nine training programs on various aspects of evaluation and regulation of medicines and medical devices. All programs are to be carried out on a full cost recovery basis.

Two training programs were successfully conducted in May (Practical training in vaccine quality assurance) and June (Medicinal products GMP training). A third program (Herbal medicines - analysis and identification) will be held in late-August.

Participants in the training programs are from Vietnam, Saudi Arabia, Indonesia, India, Taiwan and Singapore.

Over the past few months the TGA has hosted a number of overseas visitors and has provided training in a variety of areas for participants from China, Japan, Malaysia and Vietnam. AusAID, international organisations and the respective overseas governments sponsored these activities.