Lifecycle-Based Approach to Regulating Product Quality an International Perspective

1. Lifecycle-Based Approach to Regulating Product Quality an International Perspective Dr. Michael E. Oehlsen International Policy Analyst International Programs Team - Office of the Director Center for Veterinary Medicine Food and Drug Administration

2. Globalization • Globalization is a fact of 21st century economic life • The United States increasingly relies on other countries to produce the food, drugs, cosmetics, and devices we use in our daily lives • According to the U.S. Government Accountability Office nearly two-thirds of the fruits and vegetables—and 80% of seafood—eaten domestically come from outside the U.S. Half of all medical devices used in this country are imported, while 80% of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere

3. In the Future… • In the decade ahead, the world economy will be shaped by several distinct forces: the rise of emerging markets, the scarcity of natural resources, and the increased flow of capital, information, and goods across borders. • The cumulative effect of these trends means not only phenomenal growth in the import sector but increasing complexity for regulators, as the distinction between foreign and domestic products continues to blur. • Just as public health leaders all over the world have long recognized that disease knows no borders, FDA in crafting its vision for the next decade knows that product safety and quality no longer begin or end at the border.

4. Meeting Global Demand • To assure demand is being met with a drug and food supply that is both safe and efficacious the following has shown to be beneficial: “The 3 Cs” • Communication • Collaboration • Control

5. Communication • International Communication and Globalization provides an essential and timely survey of the area. • Intra- and interagency • Gov and NGO • Districts, Regions and Countries Without Global Communication, Knowledge can not be shared!

6. Communication Examples • Internet / Web based • Teleconferences / Videoconferences • Public Meetings / Workshops • International Visitor Exchange Programs • CVM examples: • Bi- Tri- and Multilateral relationships • Training • Outreach / International Capacity Building

7. Collaboration • Global collaborative initiatives should be part of a country’s long-range innovation strategy. • To help build regulatory capacity, the Institute of Medicine recommends that the FDA, other federal agencies and international organizations provide technical expertise, training and tools to strengthen the surveillance system in developing countries. • Ensuring the safety of imported food and medicines takes all countries working together, including governments, industry, academia, and other stakeholders. We should be searching out possible sources of “Collaborative Advantage."

8. Collaboration Examples • Codex Alimentarius (CODEX) • World Health Organization (WHO) • World Organization for Animal Health (OIE) • Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) • Regulatory Cooperation Council (RCC) • GMP Inspection Collaboration

9. Control • It is widely acknowledged that quality management systems improve the quality of the products and services produced. • Good data collection and analysis techniques during the design, development, and production stages are needed. • Control is required at both Pre-Market (development and design) and Post-Market (surveillance) stages of a Drug Cycle.

10. Control Examples • Quality Systems Plan • Strategic Plans • GMP/GLP/GCP • Utilization of international standards (ICH/VICH/CODEX) • Identifying Manufacturing Critical Control Points • Pharmacovigilance (monitoring drug safety post approval)

11. Three Legged Stool Drug Lifecycle Strategic Plan Communication Collaboration Control All THREE legs are needed to maintain stability of the Stool

12. A Strategic Plan is the Guide & Glue D Strategic Plan D A B B A C C

13. One-Two Legged Stool Drug Lifecycle Strategic Plan Collaboration Control Remove one or two of the legs and the stool collapses!

14. CVM Resources AAVPT Veterinary Drug Regulatory Life Cycle Course The American Academy of Veterinary Pharmacology and Therapeutics (AAVPT) sponsored a Veterinary Drug Regulatory Life Cycle Course on February 28 to March 04, 2011. The course, taught by CVM experts, was targeted to industry and academic stakeholders interested in understanding the regulatory science behind veterinary drug development. It provided an overview of current FDA CVM policies, procedures, and standards for pre- and post-approval requirements in the veterinary drug life-cycle. For access to this course and more information about CVM’s International Programs Team and other useful information, please visit: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/WhatWeDo/ucm280769.htm