This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/node/1053
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Collaborative and international assessments including work-sharing
The APVMA collaborates internationally to assess specific applications, and we may use international assessment reports in work-sharing arrangements to support independent national risk assessments.
For regulatory authorities, the various forms of sharing work can offer opportunities to make more efficient and effective use of the specialist and expert resources needed to evaluate a dossier. These arrangements may also benefit you in various ways, including:
- greater consistency and predictability in decision-making across regions
- harmonised approaches to assessment
- single dossier preparation
- coordinated access to new markets.?
You must propose the regulatory approach to the agencies involved and facilitate aspects of the planning and coordination of a global submission or work share.
Work-share arrangements do not affect our responsibility to conduct independent risk assessments and decision making. Our decisions may differ from those made in other jurisdictions because we take the local conditions and use pattern into account.
International work sharing
International work-sharing arrangements are usually established on a case-by-case basis because the circumstances of each project are likely to vary. The primary element is the sharing of a hazard assessment report that is accompanied by the original data and takes into account additional local information or data guidelines.
Global joint reviews of agricultural pesticides
A global joint review is the concurrent evaluation of a new pesticide or variations to a registered pesticide product through a globally coordinated system of evaluations, peer reviews and report sharing. Countries take lead roles in the hazard assessments of proposed pesticides, and their reports are peer-reviewed by other participating countries. These reports are shared and used as the basis for each country’s own risk assessment and decision-making, which may require the provision of data reflecting regional conditions and use patterns. The global joint review process does not extend to evaluation of efficacy and where required each country undertakes its own independent evaluation.
The Organization for Economic Co-operation and Development (OECD) has established the framework for conducting the reviews in the Guidance document on the planning and implementation of joint reviews of pesticides. This document includes detailed information on global joint review processes for applicants and regulatory authorities.
The consistent preparation of OECD-format dossiers by industry for submission in multiple OECD countries, the harmonisation of data requirements and the production of OECD-format reports that can be easily shared among regulators form part of the OECD vision.
Since Australia completed its first global joint review of a pesticide dossier in 2007, we have committed to continued involvement in these applications.
Collaborative regulatory assessment of veterinary medicines
The APVMA has participated in collaborative regulatory assessments of veterinary medicines with the Canadian Veterinary Drugs Directorate (VDD) and Agricultural Compounds and Veterinary Medicines New Zealand (ACVM NZ). We would welcome collaboration with other regulators as we can see benefits, as noted above, for the applicants and the regulators.
Collaborative proposals need to be negotiated individually. The applicant is responsible for nominating and contacting other potential participants. It is suggested that these discussions commence 6 to 12 months before anticipated submission of an application. The participating regulators will divide and share the required assessments for the application, and decide what individual (national) assessments will be required (if any). The roles of each regulator, including the appointment of an administrative lead, will be determined by agreement between the participating regulatory agencies.
An agreement between the applicant and the participating regulators, which will include the sharing of confidential commercial information and other relevant matters, must be completed before submission of the application. The applicant must nominate a project lead as their primary contact, who should be a representative of the applicant in the country whose regulator has been nominated as the administrative lead.
It is the responsibility of the applicant to provide a dossier that contains all data requirements for each country involved. The applicant must clearly identify each item of country-specific data submitted in the dossier. The same dossier must be submitted to all participating regulators.
The timeframes for assessments will be negotiated between the participating regulators based on the legislative timeframes of those countries.