1. The Benefits of VICH to VICH Member Countries and Regions DONALD A. PRATER, DVM Director, U.S. FDA Europe Office Office of International Programs Office of Global Regulatory Operations and Policy presented at 5 th VICH Conference October 28, 2015

2. A Global Marketplace Sweeping economic and technological changes have revolutionized international trade over the last several decades, creating a truly global marketplace for goods and services. 20 to 25 percent of all U.S. consumer spending is on products regulated by the U.S. Food and Drug Administration (FDA). As products are increasingly sourced from abroad, FDA’s ability to ensure the safety and quality of these imported products will depend on its execution of a myriad of global engagement strategies. FDA must assess millions of products grown, harvested, processed, manufactured, packaged, labeled, and shipped from outside U.S. borders. In 2009 alone, $2 trillion worth of FDA-regulated products manufactured in more than 300,000 foreign facilities entered the United States from more than 150 countries.

3. VICH Benefits Member Countries and Regions by: Establishing and implementing harmonized technical requirements for the registration of veterinary medicinal products –Leverages scientific and technical expertise in a time- and cost-efficient manner –Supports enhanced transparency in decision making process

4. VICH Benefits Member Countries and Regions by: Reduces animal testing, where feasible –Advances the judicious use of animal resources –Considers replacement, refinement and reduction possibilities

5. VICH Benefits Member Countries and Regions by: Potential for more and better products reaching livestock producers, veterinarians, and pet owners (*By minimizing the costs associated with product development) –Harmonized criteria eliminate redundant requirements –More streamlined and efficient global development plans for veterinary medicinal products could lead to better allocation of scarce research and development dollars for animal health –Facilitates regulatory authority’s ability to provide guidance to industry on their global development plans

6. VICH Benefits Member Countries and Regions by: Providing a basis for wider international harmonization of registration requirements –Broad range of comments can be obtained and considered by the VICH Expert Working Groups and Steering Committee –More equal access to quality, safe, and effective veterinary medicines around the world. –Minimizes potential regulatory divergence which leads to increased public confidence and fewer trade disruptions –Helps target resources for training and capacity building and strengthening regulatory systems

7. VICH Benefits Member Countries and Regions by: Provides a mechanism to monitor and maintain existing VICH guidelines –Establishes a regular cycle and structured approach to receive feedback on implementation, take into account new developments, including those on the human side in ICH, and to make adjustments when needed –Ensures an efficient process for maintaining and monitoring the consistent interpretation of data requirements following the implementation

8. VICH Benefits Member Countries and Regions by: Providing a mechanism for constructive dialogue between regulatory authorities and industry –Through this dialogue Member Countries can become aware of technical issues on implementation and significant emerging global issues and science that impact on regulatory requirements

9. Summary VICH is well-positioned to contribute to the development of veterinary medicines in a globalized world. Benefits to VICH Member Countries/Regions, as well as Observers, Emerging Countries, Industry and Consumers will accrue through the continued development of new guidelines and maintenance of existing guidelines. Trends in research, One Health, evolution of the livestock sector, and other factors will provide opportunities and challenges. Looking forward to a great 5 th VICH Conference!