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AgVetLink: Number 60, February 2007

Regulatory Control Alignment

Progress is being made on aligning the regulatory control of agricultural compounds and veterinary medicines in Australia and New Zealand. While the alignment was being progressed initially by the Australian Pesticides and Veterinary Medicines Authority (APVMA) and NZFSA, at the Alignment Steering Group meeting in December, ERMA NZ agreed to be an active participant in the work. This has created the opportunity to align on a country to country basis because the collective areas of responsibility of NZFSA and ERMA more closely parallel those of APVMA.

A work plan has been agreed to by all three Authorities. It is divided into two projects:

1. alignment of standards and requirements

2. alignment of approval processes and related matters.

The first step in project one is to develop a first order comparison of the documents that describe or set the standards and requirements of the three Authorities. With this in hand, each of the requirements areas can be compared in detail to identify similarities and differences. Working parties will develop proposals to resolve differences to either eliminate them or to establish equivalence. The requirements areas are:

• chemistry and manufacturing

• public health

• occupational safety and health

• environmental protection

• crop and animal safety, including animal welfare

• efficacy

• biosecurity/agricultural security

• trade

• labelling.

While the overall alignment programme will run for five years, the Authorities have set a goal to align the regulatory systems as much as is practical by 2010.

From NZFSA’s perspective, its alignment with ERMA NZ will be as important an outcome as the larger Australian/New Zealand alignment. It should facilitate a seamless regulatory environment that is effective in managing the risks posed by agricultural compounds and veterinary medicines and, at the same time, simplify the bureaucracy for regulated parties. Fortunately, much of the work for NZFSA will parallel the work it is already doing in reviewing its operational policies for the administration of the ACVM Act (see article on page 2).