APEC workshops on risk analysis in food safety regulation

In February and March 2000 Les Davies and Jack Dempsey from the TGA's Chemical Review and International Harmonisation Section made presentations at two APEC (Asia-Pacific Economic Cooperation) sponsored workshops on risk analysis in food safety regulation at the Chisholm Institute in Melbourne. They covered hazard and risk assessment for chemicals and food contaminants, risk analysis case studies on particular pesticides, and international sources of hazard and risk assessment information.

With responsibilities in areas such as food inspection, standards development and policy making, the 32 workshop participants hailed from a diverse range of Asia-Pacific nations including Thailand, the Philippines, Indonesia, Vietnam, the People's Republic of China, Hong Kong, Papua New Guinea, Singapore and Chinese Taipei.

Australia and New Zealand have contributed to APEC on food regulatory matters through the ANZFA (Australia New Zealand Food Authority) since 1995, and initiated a program of regional collaboration. The risk analysis workshops are an outcome of that collaboration. By facilitating information exchange, these workshops can help to align national and international standards, and promote the APEC goal of liberalising regional trade and investment.

Subject to the availability of funding, an evaluation of the effectiveness of the workshops will be undertaken later this year, and further workshops to train senior officials in the application of risk analysis in food regulation will be considered.

How to reduce application times - improving the quality of applications to list medicines solely for export

It is estimated that information provided in around 50% of recently received applications for listing of solely-for-export medicines was either incomplete or incorrect. Sponsors are reminded that it is their responsibility to provide accurate information to the TGA-penalties may apply if they recklessly make false or misleading statements. Poor quality applications cause delays in processing and hamper the TGA's ability to meet target time frames. Sponsors can ensure the accuracy and completeness of their application by consulting the checklist.

Sponsors who wish to export medicines to Taiwan or South Korea are advised that the authorities in these countries have indicated that they will not accept solely-for-export medicines, and will not respond to Prior Informed Consent (PIC) letters. Where justified - for instance, if the product is supplied in Australia and an excipient has been changed to comply with the requirements of the destination country - the Export Unit is prepared to pursue matters with the Department of Foreign Affairs and Trade on a case-by-case basis.

Requests for Certificates of Pharmaceutical Products (CPP) - how to avoid rejections

Applicants now have one opportunity to rectify errors in applications for a Certificate of Pharmaceutical Product (CPP) and resubmit the application or additional pages.

When an application for a CPP is lodged, the application and attached schedules are reviewed. If any errors are identified during the review process the sponsor is contacted by the TGA's Export Unit to make the necessary amendments and resubmit the application and/or attached schedules. Any discrepancies between Australian Register of Therapeutic Goods (ARTG) records and the sponsor's submissions are brought to the attention of the sponsor. The sponsor should liaise with ARTG staff to resolve any inconsistencies.

If the resubmitted information is still incomplete or incorrect, the application may be rejected; however, applications will not be rejected where errors are due to circumstances beyond the control of the sponsor; for example, if incorrect information has previously been entered into the ARTG. Refer to the list of the types of errors that constitute a basis for rejection <http://www.tga.gov.au/docs/html/export/cpprej.htm>.

Sponsors are also reminded that where an application has been made to vary a listing or registration, an application for a CPP should not be submitted until the variation has been approved. Further details on the information required in the application form, and the format of the schedules, will be published on the TGA website.

International Programme on Chemical Safety

The International Programme on Chemical Safety (IPCS) is a joint venture of the World Health Organisation (WHO), the United Nations Environment Programme (UNEP), and the International Labour Organisation (ILO). The IPCS Harmonisation of Risk Assessment Project is aimed at developing common risk assessment methodologies so that countries can reach transparent chemical management decisions using uniform processes and terminology.

One high priority area is the harmonisation of uncertainty and variability factors. At present, regulators use uncertainty factors (also known as safety factors) in the risk assessment of chemicals to allow for differences in toxicological effects between laboratory animals and humans (interspecies variability), and differences within the human population (human variability). The use of different uncertainty factors by different countries may lead to a variety of risk management outcomes for the same chemical, which can cause difficulties in trade and/or exchange of assessment information.

Drew Wagner, from the Chemical Review and International Harmonisation Section, is a member of the IPCS planning workgroup that met recently in the UK as part of the harmonisation project. At this meeting, case reports on several chemicals were presented in a common format developed by international experts in a workshop held in Berlin in May. The IPCS framework resulting from the Berlin meeting has been referred to a drafting group and will be circulated for comment by the end of the year. It will be an important tool for risk assessors and should result in more consistent risk assessment outcomes for chemicals.