Harmonisation

The APVMA actively participates in the harmonisation of data guidelines with our international counterparts through organisations such as the Organization for Economic Co-operation and Development (OECD) and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

We already align many areas of our guidelines with international standards; for example, the OECD guidelines for the testing of chemicals and VICH efficacy data. Hazard assessments are commonly shared internationally or worked on jointly, and are used to form the basis of each country’s risk assessment. The risk assessment then takes into account the country-specific uses of products and national policy approaches to the assessment of risks.

The alignment of Australian data guidelines with overseas regulators simplifies the assembly and submission of dossiers by industry. The use of common international methodology to assess data aligns the Australian evaluation with international best practice and improves the consistency of decision making. The use of harmonised data guidelines and assessment also promotes Australia’s ability to participate in international sharing of work and global joint reviews.

Our manufacturing requirements and standards are broadly comparable to other leading codes of good manufacturing practice such as the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme’s  Guide to Good Manufacturing Practice for Medicinal Products, 2009 and the World Health Organization’s  Quality Assurance of Pharmaceuticals—A compendium of guidelines and related materials—Volume 2, Good manufacturing practices and inspection.