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History and Importance of Terminology, the Terminology Landscape, and Options for Regulators
Institute of Medicine Workshop International Regulatory Harmonization Amid
Globalization of Biomedical Research and Medical Product Development
Washington DC, February 13-14, 2013
Mike WardHealth Canada
The Regulatory Lexicon
• Regulatory Cooperation • Harmoniz(s)ation – Convergence – Alignment –
Coherence – Integration• Equivalence – Mutual/Unilateral Recognition – Reliance• Guides – Guidelines – Standards • Laws – Regulations – Directives• Conformity Assessment• Treaties – Arrangements• Bilateral – Plurilateral – Multilateral• Adopt – Adapt - Implement
Why is this Important?
• No internationally ‘harmonized’, ‘standardized’ or ‘consensus’ definitions
• Compounded by increasing number of terms, often used interchangeably, can lead to confusion and set unrealistic or varying expectations in the minds of central agencies, regulators, industry, consumers and other vested stakeholders
• Effective cooperation begins with a common language: a possible outcome of this workshop?
Historical Underpinnings Shaping the Language of Regulation
• Need for standards driven by the Industrial Revolution
• Accelerated in the 20th Century with the rapid expansion of trade, technology and a growing consumer population
Notable Post WW2 events
• 1947: Creation of the International Organization for Standardization (ISO) and the signing of the General Agreement on Tariffs and Trade
• 1994: Marrakesh Agreement on Establishing the World Trade Agreement (WTO) -> TBT and SPS Agreements particularly important in defining Member obligations, policy and terminology in non-tariff arena
• Creation of the EEC (1957)-> EC (1967)-> EU(1993)
Internationalization of Biomedical Product Regulation
• Rapid increase and diversity of technical requirements witnessed in 1970s and ‘80s...coupled with globalization, increasing workloads, complexity of products, rising development costs, more informed public, etc.
• While initially (and still) motivated by trade and commercial considerations, desire to cooperate increasingly driven by regulators and other players
International Regulatory Cooperation (IRC)
• Inter-country activities carried out with a view to improving national regulatory outcomes and promoting convergence
• Occurs at all stages of the regulatory lifecycle• Includes a wide range of undertakings such as
information sharing, collaborative scientific work, developing common or international standards and worksharing
- adapted from draft GoC consultative document on IRC, April 2006
Harmonization – Some Definitions
• “Bringing into harmony, agreement, accord”– Common dictionary usage
• “Yields same result”– Pharmacopeial harmonization
• “The establishment , recognition and application of common… measures by different members (jurisdictions)”– WTO SPS Agreement
Considerations
• Key enabler for enhanced cooperation• May occur at different levels
– Technical requirements– Procedures and processes– Laws and regulations
• Simple in concept…more difficult in execution• Gold standard: ICH
ICH: Keys to Success
• Involvement of both regulators and industry• Science-based, consensus driven • Well managed• Limited number of players with comparable
regulatory and technical capability• Commitment of regulators to implement
products of harmonization
Adoption…Adaption…Implementation
• Adoption – Official (administrative) incorporation of a
guidance or standard into the regulatory framework “as is”
• Adaption – Deliberate changes, additions, restrictions; may or
may not respect principles of source document• Implementation
– The true measure of harmonization
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ICH Product Life Cycle
ICH Regulatory Authority
ICH Process:
Steps 1-3 Step 4 Step 5
Concept Paper
Draft for Comment
Adopt Implement
Implementation Issues
Finalize
Implementation Considerations
• Regulatory implications• Collateral policy/guidance work• Scope of application• Training/competencies• Infrastructure/system requirements• Inherent complexity of product• Readiness of industry• Resources
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“Adoption” versus Implementation
Finalized guidelineor standard
Regulatory Framework
Implementation Issues
Complete integration /implementation
Adoption or “Intent to Adopt”
PANDRH – Variation on a Theme
• Pan American Network on Drug Regulatory Harmonization established to promote pharmaceutical regulatory harmonization and capacity building within the Americas
• From the start, recognized pre-existing asymmetries within the hemisphere
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Characteristics
• Organized into 5 sub-regional economic blocks
• Broader mandate• More players with greater diversity in
capacity and needs
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A Different Definition of Harmonization
Harmonization understood to be the search for common ground within the framework of recognized standards, taking into account the existence of different political, economic and health realities among the countries of the region
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• Represents process whereby regulatory requirements across economies become more aligned over time as a result of the adoption of internationally recognized technical guidances, standards and best practices
• Does not require the harmonization of laws and regulations
• Broader concept than “harmonization” – Example: Good Review Practices
Regulatory Convergence
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Equivalence
• Two or more systems are said to be “equivalent” if, despite differences, they are expected to produce the same outcomes
• Should be established through objective means and documented
• Example: Mutual Recognition Agreements relating to conformity assessment of GMPs
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“Regulatory Cooperation – “The Continuum”
Development /adoption of same or similar standards and processes
Enhanced forms of cooperation:e.g., worksharing, reliance
Catalysts: workload, globalization, technology, public expectations
Feedback
Assess equivalence
Convergence: a dynamic process
Pharmacoverging
pharma – pertaining to pharmaceuticalsco – together, joint, jointly, mutuallyverging – being on the edge or margin of something – the limit beyond which something begins to happen
“If you want to promote change you may need to change the vocabulary”
- Capt. Justina Molzon, CDER, US FDA
Interconnectivity
“WHO should promote the principle of interconnectivity:
Information sharing and cooperation between harmonization initiatives and enabling organizations in order to build synergies, leverage capacity and sustain efforts”
- Recommendation from 13th ICDRA