Harmonisation and mutual recognition

There are many initiatives aimed at the harmonisation of requirements for the agricultural compounds and veterinary medicine registration system throughout the major parts of the world.

The main purpose of harmonisation is to develop a shared risk management framework and terminology, and this will enable harmonisation of data requirements. Within a common risk management framework each country will have different priorities in regard to acceptable thresholds and end-points, e.g. one country may have a heavier trade or welfare focus than another. However, a shared framework will increase the potential for large portions of data packages to be common to these different countries. This has significant financial and experimental animal welfare implications because a high percentage of the costs of a registration are incurred in the production of data packages.

One widely known harmonisation initiative for veterinary medicines is VICH, the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. The membership of this programme is the European Union, the United States of America and Japan, with Australia and New Zealand as active observers. Working groups are developing recommendations on technical requirements in a wide variety of areas. Once these recommendations are adopted they replace the regional requirements.

On the plant compound side of harmonisation, twenty-nine countries, including New Zealand, are members of the OECD, the Organisation for Economic Cooperation and Development. The two major areas that have been agreed are guidance for industry data submissions and the format for regulatory assessments. The group is now developing guidelines for data interpretation.

The Codex Alimentarius provides for harmonisation of maximum residue limits for agricultural compounds and veterinary medicines in trade produce. These limits are set by consensus by member countries, with linkage to the World Trade Organisation providing support for acceptance of produce conforming to the limits.

Harmonisation is also particularly valuable between Australia and New Zealand and to that end the Australia New Zealand Registration Manage-ment Committee has been established. This group has been looking at the harmonisation of labelling require-ments with some success, although the current uncertainties as to the requirements of the HSNO Act has temporarily limited further progress. The committee is also reviewing technical requirements and developing recommendations on the harmon-isation of these requirements.

Mutual recognition
Harmonisation does not mean mutual recognition. The term ‘mutual recognition’ applies to instances where registration by one regulatory authority is accepted as sufficient for registration by a second country.

In most areas mutual recognition is not likely in the near future. However, New Zealand and Australia are in the process of formalising the mutual recognition agreement for assessment of Good Manufacturing Practice (GMP). This means manufacturing premises are not required to be inspected for GMP by both countries.

There is a mutual recognition agreement being developed between New Zealand and the European Union for the conformity assessment of GMP. This process is currently in the period of confidence building and document exchange is underway.

There is as yet no formal agreement between New Zealand and the United States for GMP assessment; however, there are collaborative inspections with American inspectors.