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
Typical activities for a global company selling products in over 100 countries
Product
Registrations
Inspections
Pharmaceuticals
2,500-5,000
50-70
Devices
40-60
Nutritionals
70-100

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 America 45%
Europe 26%
Japan 14%

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

7. Current Global Regional Harmonization Efforts
Registration
Manufacturing Controls
Performance Standards
Nutritionals
WHO Codex Standards
ICH GCP
WHO Code Alimentaris
EU Directive 1999/21/EC
Pharmaceuticals
ICH M4 CTD
ICH M2 eCTD
CDISC
ICH Q Series
MRA
ICH E, Q, & M Series
Devices
ISO 14155
ISO 14971
ISO 15142
ISO 15223
ISO 15225
MRA, GHTF, QSR
EN36001
ISC 13485
ISO 13488
ISO 11138
ISO 14969
AAMI/ANSI HE
PREN 13640
IEC 60601
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