2.3 – Good Regulatory Practices - ICH

L1
2.3 – Good Regulatory Practices
Presentation to APEC Preliminary Workshop
on Review of Drug Development
in Clinical Trials
Celia Lourenco, PhD,
Manager, Clinical Group I
Office of Clinical Trials
Therapeutic Products Directorate
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Slide 1
L1 Lourenco; 28.01.2008

Disclaimer: the information within
this presentation is based on the
presenter's expertise and
experience, and represents the
views of the presenter for the
purposes of a training workshop
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Good Regulatory Practices
Develop regulations that are flexible
Use risk management principles
Be consistent in guidance and decision-making
Be efficient in information and records management
Measure and maintain performance and transparency
Be reacheable and reach out to stakeholders
Be aware of changing regional and global factors in
R&D and access to drugs
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Flexibility of Regulations
• Regulations should:
– Cover principles broadly
– Provide sufficient protection to the public
– Strike a balance between protection of the
public and enabling R&D
– Be forward-looking, allowing flexibility for
regulating in the current and future
environment
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Use Risk Management Principles
• Science-based risk management, with risk-based
decision-making
• Precautionary principle: “absence of full scientific certainty
shall not be used as a reason to postpone decisions when
faced with the threat of serious or irreversible harm”
• Proactive – take initiative to address and prevent public
health & safety concerns:
– Safety of Canadian blood system
– Bovine spongiform encephalopathy / Creutzenfeldt-Jakob disease
– Pandemic influenza
• Know own strengths and weaknesses:
– Consult with experts on complex scientific, medical, or regulatory
issues
– Implement and make use of scientific advisory committees
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Consistency in Guidance and
Decision-Making
• Adopt international guidelines when appropriate
• Develop SOPs:
– Good guidance practices
– Good review practices
• Develop and implement guidelines to address
regional issues
• Be aware of drivers, such as globalization
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Efficiency in Information and Records
Management
• Develop and implement tools to manage documents
and information submitted by sponsors
– Maintain accurate records with a numbering system for
sponsor/drug and submissions
– Clinical trial applications, amendments and notifications
– ADR database for integration and analysis
– Submission allocation database
– Clinical trial inspection database
• System to manage other information such as general
enquiries
• Ensure security and maintain confidentiality of records 8

Measure and Maintain Performance and
Transparency
• Measure workload and performance at periodic
intervals (e.g., quarterly)
• Use information on workload and performance
to develop/revise business plans
• Publish performance measures periodically
(e.g., annually)
– Number of clinical trials, protocol amendments,
notifications, ADRs, types of trials, etc.
– Submission processing and review times
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Be Reacheable and Reach Out to
Stakeholders
• Provide opportunities for dialogue with sponsors and
stakeholders formally and informally (e.g., pre-clinical
trial meetings, telephone conferencing, informal email
enquiries)
• Provide for appeal processes and opportunities for
reconsideration of final decisions
• Consult with all stakeholders before implementing or
adopting new regulations, policies, and guidelines
• Consult with stakeholders as early as possible
• Communicate horizontally within organization
• Seek lessons learned through impact analyses
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Impact on R&D: Regional Factors
• Analyze regional factors:
– Population (e.g., demographics, disease prevalence)
– Health care system and infrastructure
– Available expertise
– National support in research funding
– Regulatory frameworks for importation and sale of
drugs
– Geographic location and neighbouring countries
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Impact on R&D: Global Factors
Be aware of, and prepare for, global impact &
trends:
– Multinational clinical trials
– Harmonization
– Decreased number of blockbuster drugs & exponential
rise in generics
– Personalized medicine, pharmacogenomics
– Rising costs and emerging markets
– In choosing to place a clinical trial, companies will look
for countries with the appropriate laws, along with the
required population, disease prevalence, health care
system, qualified investigators and staff, with high
standards of professional integrity and ethics
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References
Annual Drug
Submission Report
TPD Annual
Performance
Report
Decision-Making
Framework for
Identifying,
Assessing, and
Managing Health
Risks (2001)
Good Guidance
Practices
Ten Hallmarks of a
Good Review
Good Review
Practices
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/pdf/prodpharma/grp_fs_bpe_fd_v2_e.pdf
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/pdf/prodpharma/tpd_rep_dpt_rap_2006-07_e.pdf
http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/riskrisques_tc-tm_e.html
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/pdf/prodpharma/grp_bpe_princip_v2_e.pdf
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/pdf/prodpharma/tpd_dpt_annual_annuel_06_e.pdf
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applicdemande/guide-ld/ggp-bpld/index_e.html
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