regulatory harmonisation – industry perspective
DESCRIPTION
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?. - PowerPoint PPT PresentationTRANSCRIPT
Regulatory Harmonisation – Industry Perspective
Dr Peter HonigVP Global Regulatory Affairs and Patient SafetyAstraZeneca L.P.
Institute of MedicineInternational Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development
2
Why promote harmonisation?
Faster access to medicines
Reduced duplication
Fewer clinical trials needed
Sharing of experience
and knowledge
Better use of limited
resources
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
Nature Rev Drug Dis (2008:7)
Significant Growth in Asia and other Emerging Economies
.
8
Multi-regional Clinical Trials and Regulatory Expectations
9
Different subset analyses are required by HAs(assumes Phase III participation
China
China Ph III data
China PK study
Korea
Korea Ph III data
ICH E5 Assessment
Asian data* supportive (Japan + China + Taiwan + Korea)
Taiwan
ICH E5 Assessmen
t
Asian data (Japan + China + Taiwan + Korea)
India, Mexico, Vietnam
Own domestic
Indian patient data or
Mexican patient data or Vietnam patient
data
Science is not the only driver behind non-ICH clinical requirements.
10
Established harmonisation initiatives:• International Conference on Harmonisation• Guidelines on Quality, Safety, Efficacy• Common Technical Document
ICH
• European Medicines Agency, European Commission and Heads of Medicines Agency
• Harmonised European regulated market
European Union
• Established medicinal, clinical and technical standards; promotes regulatory capacity building training and work sharing for Regulatory Authorities
WHO
• Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme
• Inspection of manufacturing sitesPIC/S
• FDA/EMA QbD pilotFDA
initiatives
11
Regional Harmonisation Initiatives:
Honig/February 2013
• Regional Harmonisation Initiative representatives and individual DRAs participate in ICH technical discussions
ICH - Global Cooperation Group
(GCG)
• African Medicines Regulatory Harmonisation (AMRH)• Funded by World Bank Trust Funds (BMG
foundation)Africa
• Asia Pacific Economic Cooperation (APEC) and Association of Southeast Asian Nations (ASEAN)
• Asian Economic Community (AEC) - harmonization of technical standards and regulatory requirements under the Pharmaceutical Product Working Group (PPWG)
Asia Pacific
• PAHO and the Pan American Network for Drug Regulatory Harmonization (PANDRH) Latin America
• Gulf Central Committee for Drug registration• League of Arab NationsMiddle East
12
Other initiatives:
Honig/February 2013
WHO CPP Scheme• Globally accepted• Avoids duplicated
reviews
WHO Pre-Qualification Scheme• Aids fast
registration of essential drugs
WHO ICDRA Conference• Promotes
International Harmonisation
Europe
• Clinical Trial Regulation
• Harmonisation of Clinical Trials in Europe
13
What challenges remain for existing initiatives?• Gap between emerging and developed
countries• Need to focus on value added
processes
Regulatory Capability
• Initiatives based around existing frameworks of regional economic interests
• Inter-regional cooperation also required
Regional Harmonisation Initiatives
• Focus on new chemical and biological substances and dosage forms
• Harmonisation in life cycle management also needed
ICH
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What challenges remain for existing initiatives?• Globalisation of CTs (larger population
of patients – faster recruitment)• New regions, with local requirements
Clinical Trials
• Substandard products• Expectations of regulators• Capacity of regulators to conduct
assessments
Quality Standards
• Duplicative re-inspection of sites pre-approval (manufacturing, clinical trial sites)
• Recognition of other inspections and certification
• FDA/EMA/TGA API inspection pilot
GXPInspection
s
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?Simultaneous
Global Development
Adaptive trials
Acceptability of end points
Requirements for companion
diagnostics
Pharmacoviilance & Risk
Management
HTA & Reimbursement Decisions
Supply Chain Integrity
Data Transparency
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
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Back-up slides
20
ChinaChina CSR +
summary docs
MexicoNew Molecules Meetingand Clinical Summary
South KoreaBridging Position
Paper
TaiwanBridging Study
Checklist
IndiaIndia Subgroup
Report
VietnamSubgroup
report
Examples of national requirements for Clinical sub-group analyses and market specific documents
21
Examples of non-ICH clinical documentation requirementsCountry/Regional Clinical Sub-group
analyses* requiredCountry/Regional Clinical Sub-group analyses NOT required
China:Mainland Chinese patients analysis including ‘China CSR’
China:China PK study report
Mexico:Mexican patient subgroup analysis for a New Molecules Committee Meeting and Summary
China:China Summary Documents & Clinical Study Statistical Database
Vietnam:Vietnamese patient analysis for the ‘Vietnamese CSR’
China:China Special Review Process application(if required)
Korea:Korean patient analysis for the Bridging Position Paper
Brazil:Therapeutic Index
India:Indian patient analysis for the Indian Summary
Association of South East Asian Nations:ASEAN format CTD
Taiwan:Asian** patient subgroup analysis for Bridging Study “Checklist”
General:International Clinical Document &Summary of Medical Benefits
* Clinical Sub-group analyses = Country or region specific sub-analysis of key efficacy and safety endpoints including SAEs and most common AEs** Asian used to mean Japan + China + Korea + Taiwan