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History and Importance of Terminology, the Terminology Landscape, and Options for Regulators

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 Ward

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History and Importance of Terminology, the Terminology Landscape, and Options for Regulators

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  1. 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 Ward Health Canada

  2. 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

  3. 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?

  4. 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

  5. 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)

  6. 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

  7. World of Harmonization Initiatives

  8. Framing the Discussion – Some Important Terms

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. ICH Product Life Cycle ICH Regulatory Authority ICH Process: Steps 1-3 Step 4 Step 5 Concept Paper Draft for Comment Finalize Adopt Implement Implementation Issues

  15. Implementation Considerations • Regulatory implications • Collateral policy/guidance work • Scope of application • Training/competencies • Infrastructure/system requirements • Inherent complexity of product • Readiness of industry • Resources

  16. “Adoption” versus Implementation Regulatory Framework Finalized guideline or standard Implementation Issues Complete integration / implementation Adoption or “Intent to Adopt”

  17. 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

  18. Characteristics • Organized into 5 sub-regional economic blocks • Broader mandate • More players with greater diversity in capacity and needs

  19. 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

  20. Regulatory Convergence • 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

  21. 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

  22. “Regulatory Cooperation – “The Continuum” Assess equivalence Development /adoption of same or similar standards and processes Enhanced forms of cooperation: e.g., worksharing, reliance Feedback Convergence: a dynamic process Catalysts: workload, globalization, technology, public expectations

  23. Two New Terms • “Pharmacoverging” • “Interconnectivity”

  24. Pharmacoverging pharma – pertaining to pharmaceuticals co – together, joint, jointly, mutually verging – 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. JustinaMolzon, CDER, US FDA

  25. 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

  26. A Global Regulatory Village

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