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Regulatory Harmonisation – Industry Perspective

Regulatory Harmonisation – Industry Perspective. Institute of Medicine International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development. Dr Peter Honig VP Global Regulatory Affairs and Patient Safety AstraZeneca L.P. Why promote harmonisation?.

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Regulatory Harmonisation – Industry Perspective

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  1. Regulatory Harmonisation – Industry Perspective Institute of Medicine International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development Dr Peter Honig VP Global Regulatory Affairs and Patient Safety AstraZeneca L.P.

  2. Why promote harmonisation?

  3. Industry Strategic Priorities • Increase Probability of Success (POS) • Reduce Development Cycle Times • Lower Development Costs • Organic and inorganic growth in expanding economies. All four may be facilitated by Global Development Strategies and Regulatory Harmonization

  4. Industry Focus on Globalization • Access • Access to scientific talent • Access to patients to facilitate clinical trial accrual • Access to lower cost suppliers and operational support • Access to markets • Public • Private

  5. Changing Global landscapeEconomic homunculus of the world in 2015 • Source : Worldmapper • Note : Territory size shows the proportion of worldwide GDP measured in US$ equalised for purchasing power parity.

  6. Globalization of Clinical ResearchDensity of Actively Recruiting Clinical Sites(per million inhabitants) Nature Rev Drug Dis (2008:7)

  7. Global trends in Participation in Clinical Trials Significant Growth in Asia and other Emerging Economies . Nature Rev Drug Dis (2008:7)

  8. Multi-regional Clinical Trials and Regulatory Expectations

  9. Different subset analyses are required by HAs(assumes Phase III participation Science is not the only driver behind non-ICH clinical requirements.

  10. Established harmonisation initiatives:

  11. Regional Harmonisation Initiatives:

  12. Other initiatives:

  13. What challenges remain for existing initiatives?

  14. What challenges remain for existing initiatives?

  15. Benefits of Harmonization are Clear and Tangible • Standardization of QSE requirements and format, content of regulatory documentation. • Reduction of cost and time for both regulators and industry. • Improve the capacity of DRAs through more efficient and collaborative use of resources. • Bring new therapies of pre-specified QSE to patients faster and at lower cost to all stakeholders • Downward pressure on the price of QSE medicines by enabling greater economies of scale and a leveled regulatory playing field.

  16. Reason for Optimism • Progress in CTA requirements/timelines • Investment in clinical trial and human protection oversight infrastructures in non-ICH regions including Asia • Evolving understanding of impact (or lack thereof) of ethnic and practice influences on acceptability of foreign clinical trial data • Recent movement on CPP requirements in non-ICH regions (Singapore HSA, Taiwan) • Growing acceptance of ICH guidelines and CTD • APEC LSIF, AHC and Tripartite Initiative providing regulatory science to inform policy and future practices

  17. Can we do even more? Training and Capacity Building

  18. However you say it, it means the same thing….. world wide. Thank you! Dank u Danke Grazie Gracias Obrigado Merci Tak Спасибо 元気です ありがとう 謝 謝 고맙습니다. Ahsante Sana

  19. Back-up slides

  20. Examples of national requirements for Clinical sub-group analyses and market specific documents China China CSR +summary docs India India SubgroupReport South Korea Bridging PositionPaper Taiwan Bridging StudyChecklist Vietnam Subgroupreport Mexico New Molecules Meetingand Clinical Summary

  21. Examples of non-ICH clinical documentation requirements

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