1 Integration of Standards, Business and International Trade Operating Within a Complex Global Standards Environment for Medical Products Presented by Tom Gonzalez Divisional Vice President, Corporate Regulatory And Quality Science Abbott Laboratories

2 Global Standards Environment for Medical Products ProductRegistrationsInspections Pharmaceuticals2,500-5, Devices Nutritionals Typical activities for a global company selling products in over 100 countries

3 This Represents ¼ of the Paperwork Required to Register a Pharma Product in the U.S. New Drug Application Metrics A full submission can be 1000 volumes of 350 pages Development of a new drug can take 8 years and $ 1B(U.S.) Every day of delay in product introduction represents $ 1M(U.S.) in lost sales

4 Issues With Current Environment Mutual Recognition Agreements are Difficult to Implement Time to Market Across Countries is Delayed Cost of Compliance is High Product Availability is Impacted Activities and Operations are Duplicated

5 Global Standards Environment for Medical Products The good news is that of over $500 billion (U.S.) in worldwide sales, 85% is in the following regions North America45% Europe 26% Japan14%

6 Opportunities for Harmonization of Standards for Medical Products Where have we been? JAPAN APAC U.S. EU LA ROW CANADA AUSTRALIA Harmonization Efforts ISO ICH WHO GHTF MRA Compendia Where are we going? AUSTRALIA CANADA EUROPE JAPAN UNITED STATES PACIFIC RIM LATIN AMERICA

7 Current Global Regional Harmonization Efforts RegistrationManufacturing ControlsPerformance Standards NutritionalsWHO Codex Standards ICH GCP WHO Code Alimentaris EU Directive 1999/21/EC PharmaceuticalsICH M4 CTD ICH M2 eCTD ICH GCP CDISC ICH Q Series MRA ICH E, Q, & M Series DevicesISO ISO ISO ISO ISO MRA, GHTF, QSR EN36001 ISC ISO ISO ISO AAMI/ANSI HE PREN IEC GHTF/SG2/N7R1:1999 GHTF/SG2/N20R10:2002 ISO IEEE ANSI AAMI

8 Harmonization: What can it mean for stakeholders? GOVERNMENT Consistent global requirements for product registration, manufacturing practices and product performance standards, safety, and efficacy Ability to develop mutual recognition agreements MEDICAL PROFESSIONALS/PATIENTS Consistency in quality across global regions Lower cost to consumers of medical products Availability of therapeutic and diagnostic advances in technology

9 Harmonization: What can it mean for manufacturers? Increase market access and acceptance Reduce time and cost of product development Faster time to market Reduce administrative and operational expenses Reduce number of required registrations and inspections Drive economics of scale Portability of employee knowledge across global regions

10 Potential Manufacturer’s Approach to Dealing with Harmonization Global focus on pharmaceutical, device, and nutritional standards Information/policy organization responsible for monitoring global standards developments Active participation and leadership within standards and trade organizations Sharing of standards development information to all company operating groups Deployment of standards requirements through company-wide policy system