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Animal Drug Import Tolerances Under ADAA of 1996

Animal Drug Import Tolerances Under ADAA of 1996. FDA’s Public Health Protection, International Harmonization, and Trade-Related Goals Merton V. Smith, Ph.D., J.D. Special Assistant for International Activities Office of the Center Director, CVM

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Animal Drug Import Tolerances Under ADAA of 1996

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  1. Animal Drug Import Tolerances Under ADAA of 1996 FDA’s Public Health Protection, International Harmonization, and Trade-Related Goals Merton V. Smith, Ph.D., J.D. Special Assistant for International Activities Office of the Center Director, CVM Veterinary Medicine Advisory Committee Meeting January 22, 2002

  2. Increasing Emphasis on International Harmonization • Growing volume of FDA-regulated imports • Demand for quick consumer access to new products • European movement toward a unified market • Bilateral and multilateral trade negotiations • New legislative mandates • Recommendations for increased international harmonization

  3. Increasing Emphasis on International Harmonization • Growing volume of FDA-regulated imports • Demand for quick consumer access to new products • European movement toward a unified market • Bilateral and multilateral trade negotiations • New legislative mandates • Recommendations for increased international harmonization

  4. Policy Statements and Recommendations • Food and Drug Law Institute Study of Future Trends in Regulation (1988) • Advisory Committee on the FDA (1991) • Administrative Conference of the United States (1991) • White House Council on Competitiveness (1991) • World Health Organization Resolution (1992) • FDA Task Force on International Harmonization (1992) FDA Policy on International Memoranda of Understanding (1995) • FDA Policy on Standards (1995) • National Performance Review: Reinventing Food Regulations (1996)

  5. International Agreements • North American Free Trade Agreement (NAFTA)--signed December 17, 1992 • World Trade Organization Agreements (WTO)--signed April 15, 1994 • Others: trade, environment, scientific and regulatory cooperation

  6. NAFTA Provisions Covering Sanitary & Phytosanitary (SPS) Measures • Each party may establish and enforce levels of protection that it considers appropriate • Measures must be nondiscriminatory • No unnecessary obstacles to trade • Parties shall work toward compatibility of measures and treat as equivalent measures meeting the importing party’s legitimate objectives

  7. NAFTA Provisions Covering SPS Measures (continued) • International standards are to be used as the basis for national standards • Parties can apply any measure that results in a level of protection higher than an international standard but it must be science-based and only applied to the extent necessary to achieve the established level of protection • Technical Working Groups

  8. WTO Provisions CoveringSPS Measures • Countries have the right to adopt and enforce measures necessary to protect health • Countries shall ensure that measures are applied only to the extent necessary to protect health • Measures must be nondiscriminatory • Measures shall be based on scientific principles and not be maintained without sufficient scientific evidence

  9. WTO Provisions Covering SPS Measures (continued) • Importing country must accept measures as equivalent if the exporting country objectively demonstrates to the importing country that measures achieve the importing country’s appropriate level of protection • Measures shall be based on international standards, except where they provide a higher level of protection and then they must be scientifically justified

  10. FDA Legislation Before 1997: Federal Food, Drug, and Cosmetic Act did not specifically mention international harmonization* but the following sections provide FDA’s authority: • Section 701(a) of FFDCA: broad rulemaking authority • Section 801 of FFDCA: decisions on imports • Section 301 of PHSA: broad authority for public health cooperation • Section 351 of PHSA: authority to control drugs and medical devices • Section 361 of PHSA: authority to control communicable disease

  11. FDA Legislation (continued) Provisions of the FDA Modernization Act of 1997: • FDA must participate with other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve reciprocal arrangements as determined to be appropriate by FDA in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products

  12. FDA Legislation (continued) Provisions of the FDA Modernization Act of 1997: • FDA must support USTR in meetings with other governments to discuss ways to reduce the burden of regulation and harmonize regulatory requirements for medical devices if FDA determines that such harmonization is consistent with the purposes of the Federal Food, Drug, and Cosmetic Act

  13. FDA Legislation (continued) Provisions of the FDA Modernization Act of 1997: • Support USTR in efforts to move toward acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices between the European Union and the United States

  14. FDA Regulations and Guidance Related to International Harmonization and Equivalence Determinations • 21 CFR 130.6 Review of Codex Alimentarius food standards • 21 CFR Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community • Draft Guidance on Equivalence Criteria for Food (62 FR 30593; June 4, 1997)

  15. Approaches to International Harmonization by other U.S. Regulatory Agencies • Animal and Plant Health Inspection Service • Food Safety and Inspection Service • Environmental Protection Agency

  16. Summary FDA’s primary goal with regard to its international harmonization activities is to preserve and enhance its ability to accomplish its public health mission; including • maintaining high standards of protection • enhancing regulatory effectiveness, and • increasing worldwide consumer access to safe, effective, and high quality products

  17. Summary (continued) • Trade agreements permit the establishment and enforcement of measures that provide a level of protection considered appropriate by the importing country. • Measures may be more protective than international standards but they must be science-based and serve to effect the importing country’s chosen level of health protection. • Where consistent with the consumer protection purposes of FFDCA, FDA must harmonize requirements and seek appropriate reciprocal arrangements based on determinations of equivalence

  18. Summary (continued) • FDA’s regulations satisfy the obligations in NAFTA and WTO because they are nondiscriminatory, solidly grounded in science, and based on what the United States has chosen as the appropriate level of protection

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