Leadership in Collaborative Bilateral Project for Simultaneous Animal Drug Review
Canadian Prime Minister Stephen Harper and President Barack Obama created the U.S. – Canada Regulatory Cooperation Council (RCC) in February 2011. After private sector consultations and bilateral negotiations, the RCC released the Joint Action Plan on Regulatory Cooperation in December 2011. The Joint Action Plan is a practical step to increased regulatory cooperation between the U.S. and Canada. The veterinary drug initiative under the RCC enhances the pre-market evaluation of veterinary drugs.
Under CVM leadership, a U.S. working group collaborated with Health Canada (HC) to prepare a work plan to develop a simultaneous review process for approving new animal drugs. To make this simultaneous review possible, both countries need to synchronize the new animal drug application submission and review of the same fundamental data set. The work plan includes an evaluation of the simultaneous review activities toward the creation of a full simultaneous review process in the future. While recognizing the independent decision-making of each country, these actions will facilitate the simultaneous availability of drugs to end users in both countries, and will further align Maximum Residue Limits (MRLs) or tolerances whenever possible. Simultaneous review permits better use of resources and provides a larger pool of scientific personnel. The plan outlines key elements to facilitate systemic alignment of regulatory systems, strategies, and practices between HC and FDA. In July 2012, CVM participated in a joint U.S. - Canada presentation on the progress of the RCC activities to the regulated industry.
Implementation accomplished during the year included a pilot project, the first step toward more frequent simultaneous veterinary drug access on both sides of the border when a drug manufacturer decides to apply at the same time in the U.S. and in Canada. FDA and HC completed the evaluation of the first animal drug application during the year, and did so sooner than expected. This early success has had a very positive effect on the industry’s view of the RCC program. An additional eight compounds are targeted for simultaneous review.
The RCC veterinary drug plan has 16 action items, within two main categories: simultaneous review, and building on scientific collaboration in the establishment of comparable human food safety standards. Implementation is ahead of schedule, with three items completed and 10 items in progress at the end of the fiscal year, and three items remaining to be scheduled.
Through development and implementation of this work plan for veterinary drugs, with CVM leadership, FDA and HC have fostered the pursuit of real opportunities to leverage capacity and expertise. This is in addition to identifying and implementing effective ongoing systems strategies to help both agencies meet their public health missions, to better align regulatory requirements, and to avoid unnecessary duplication in areas of mutual interest.