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Integration of Standards,Business and International Trade

Operating Within a Complex Global Standards Environment

for Medical Products

Presented by Tom GonzalezDivisional Vice President,

Corporate Regulatory And Quality ScienceAbbott Laboratories

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Global Standards Environmentfor Medical Products

Product Registrations Inspections

Pharmaceuticals 2,500-5,000 50-70

Devices 300-400 40-60

Nutritionals 200-300 70-100

Typical activities for a global company selling products in over 100 countries

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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

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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

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Global Standards Environmentfor 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%

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Opportunities for Harmonizationof Standards for Medical Products

Where have we been?Where have we been?

JAPANJAPAN

APA

CA

PAC

U.S.

U.S.

EUEU

LALA

ROWROW

CANADA

CANADA

AUSTRALIA

AUSTRALIA

HarmonizationHarmonizationEffortsEfforts

ISO ICHWHOGHTFMRACompendia

Where are we going?Where are we going?

AUSTRALIAAUSTRALIA

CANADACANADA

EUROPEEUROPE

JAPANJAPAN

UNITED STATESUNITED STATES

PACIFIC RIMPACIFIC RIM

LATIN AMERICALATIN AMERICA

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Current Global Regional Harmonization Efforts

Registration Manufacturing Controls Performance Standards

Nutritionals WHO Codex Standards

ICH GCP

WHO Code Alimentaris WHO Code Alimentaris

EU Directive 1999/21/EC

Pharmaceuticals ICH M4 CTD

ICH M2 eCTD

ICH GCP

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 742001

PREN 13640

IEC 60601

GHTF/SG2/N7R1:1999

GHTF/SG2/N20R10:2002

ISO

IEEE

ANSI

AAMI

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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

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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

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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