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Building quality into the Decision-making process: The role of
frameworksEmerging markets Agency
Joey Gouws
Utilisation of a Common Benefit-Risk Framework: Can it facilitate decision making and improve communication within and across agencies
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Overview
• Introduction
• Regulatory Challenges 2015
• Quality decision making process
• Framework of Quality management system
• Quality across boarders
• Closure
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Introduction
Elements of effective Medicine Regulation: WHO, 1999
– Good regulatory practice and standards– Adequate and appropriate:
• human• Financial• Technical• Physical resources• supported by appropriate SOPs and policy
guidelines– Regulation based on risk– Limits to discretionary powers
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Background
• SADC Population 277 million
• SADC 15 countries
• Approximately 4% of world population
• 15% of the world’s population consumes
88-91% of FPPs
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Regulatory challenges
• Regulators faced with increased workload and limited resources
• Increasing concerns of the safety of medicines require advancing pharmacovigilance systems and strengthening capacity
• The WHA resolution 63.12 (2010) require assure quality, safety and availability of blood for transfusion
• Word-wide call regulatory oversight of Herbal medicines to ensure quality and safety
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Regulatory challenges…cont
• Word-wide requirement to assure regulatory oversight of Medical Devices and IVDs to ensure safety, quality and performance
• Recent EU legislation which reformed the rules of importing APIs for medicinal use require immediate regulatory oversight of API manufacturers
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Quality decision-making processesMandate of each NRA: protect the public through quality
decisions:Baseline:• NRA’s strive
– implement good regulatory review practices among assessors– a robust regulatory decision and action– endeavour implement quality management system
• Applicants expect– scientific integrity, communication, transparency and
consistency in review processes.
• Relationship between the quality of the regulatory dossiers and – the way in which the review is conducted– successful review outcome
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Presentation
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Presentation CTD: PART 2A
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Quality Management system
• Within a RA QM system is influenced – Size
– Resources
– Competencies
– Particular objectives
– Processes it employs
– Organizational structure.
• Successful QM implementation– requires senior management commitment
– responsibility of everyone in the organization
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Quality Management system… cont
Elements of GRevPs: WHO, 2014
– Achieve timelines
– Predictability
– Consistency
– Transparency
– Clarity
– Efficiency
– Quality in both the content and management of reviews
Elements of GRevPs: CIRS, 2014
– Enable timelines
– Predictability
– Consistency
– Transparency
– Clarity
– Efficiency
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Quality Management system … cont
Elements of GRevPs: WHO, 2014
• Review tools: – Standard Operating Procedures (SOPs
– Templates
– Reviewer learning activities:• Training courses
• Mentoring
• Orientation packages
• Discussion sessions
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Quality cycle
General knowledge:
• The quality cycle is made up of four key components: – Pre defined processes captured in key documents:
assessment templates, guidelines and SOP’s
– Daily execution of directives
– Monitor and review practices
– Improve reviews due to evolving science or adoption of new processes
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Quality cycle: Processes
Pre defined Processes– Key documents
• assessment templates• Guidelines• SOP’s
– Define processes for decision-making• Decision frameworks• Use external experts• Internal meetings• Time frames for completion and communication of reviews• Peer-review (Internal and External reviewers)
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Processes: Benefit – risk considerations
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Quality cycle: Processes ….cont
Standard operating procedures
• SOP’s enables the RA to
– Outline the workflow processes
• multiple reviewers assess different parts of the same application [5 review processes]
• multiple applications to review [1800 applications/annum]
– Review applications in a consistent manner
– Staff training.
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Quality cycle: Processes….cont
• Additional documents supporting SOP’s– Guidelines for reviewers and Applicants
• Specific information called for• Transparency• Training• Public consultation
– Templates• Provide specific information• Information in structured, consistent manner• Training
– Checklists• Ensure task completed• Training
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What guides the submission & evaluation?
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Module 1 cont.
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Module 2 (Cont.)
2.3.A APPENDICES
2.3.A.1 Facilities and Equipment
2.3.A.2 Adventitious Agents Safety Evaluation
2.3.A.3 Novel Excipients
2.3.R REGIONAL INFORMATION
2.4 NONCLINICAL OVERVIEW
2.4.1 Overview of the Nonclinical Testing Strategy
2.4.2 Pharmacology
2.4.3 Pharmacokinetics
2.4.4 Toxicology
2.4.5 Integrated Overview and Conclusions
2.4.6 List of Literature Citations
2.5 CLINICAL OVERVIEW
2.5.1 Product Development Rationale
2.5.2 Overview of Biopharmaceutics
2.5.3 Overview of Clinical Pharmacology
2.5.4 Overview of Efficacy
2.5.5 Overview of Safety
2.5.6 Benefits and Risks Conclusions
2.5.7 References
Module 2 (Cont.)
2.6 CONTENT OF NONCLINICAL WRITTEN AND TABULATED SUMMARIES
2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.3 Pharmacology Tabulated Summary (Appendix B)
2.6.4 Pharmacokinetics Written Summary
2.6.5 Pharmacokinetics Tabulated Summary (Appendix B)
2.6.6 Toxicology Written Summary
2.6.7 Toxicology Tabulated Summary (Appendix B)
2.7 CLINICAL SUMMARY
2.7.1 Summary of Biopharmaceutics and Associated Analytical Methods
2.7.2 Summary of Clinical Pharmacology Studies
2.7.3 Summary of Clinical Efficacy
2.7.4 Summary of Clinical Safety
2.7.5 References
2.7.6 Synopses of Individual Studies
Numbering system Module 2 contd
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Quality cycle: Execute
Daily executive of directives– Implement processes defined and adhere to
specified time frames [execute MCC resolution]
– Continuous training:• professional development
• mentoring
• on-the-job training
– Record decision making process:• collect in key documents i.e. minutes, letters and
reports [file on product or company documents]
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Quality cycle: Monitor
Monitor practices – Ensure review procedures and templates
consistently interpreted and applied through the assessment of internal peer review feedback by internal and external experts
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Quality cycle: Improve
Improve – Review documentation and decision-making
processes
– Introduce improvements to the review and decision-making process by• internal assessment of a review
• peer review
• internal quality audits
– Implement new and improved work practices advancements [2015 processes initiated].
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Evaluation process
• Consist
– Validation (Screening) as per SOP, template, guideline
• Check completeness of the application
• File organized , forms, documents
• Target time frames for screening
• Benefit:– Applicants - predictable and clear process
– RA - Applicants submit complete applications
– Scientific review
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Quality across borders
• ZaZiBoNa project
– Zambia
– Zimbabwe
– Botswana
– Namibia
• ZaZiBoNaS• 2015 South Africa to join
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Quality across borders: ZaZiBoNa
• Joint assessment using WHO format & guidelines
• Secretariat: Hosting country
• Host Country: Selects products for evaluation
• Applicants involved.
• Rapporteur: All countries
• Prior to meeting: Country perform 1st evaulation
• At meeting: Discussion, consensus, report
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Quality across borders: ZaZiBoNa…cont
• Consolidate list of Questions to Applicants
• 2nd meeting: Rapporteurs present assessed response
• Final decisions after discussion of the 2nd
response from applicant.
• Country execute own decision
• Status:– 4 Meetings
– 50 dossiers assessed
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Closing: Decision making process
• Public health priority of the medical product application• Understanding specific intrinsic and extrinsic factors
– Relevancy of data available to the RA’s population • genotypes and phenotypes,• disease manifestation and study population
• Identification of major scientific questions and their possible resolution – Info needed for acceptable level of certainty to meet regulatory
standards for marketing authorization versus info to be collected in the post-marketing period
• Understanding the Risk Benefit profile in terms of patient safety
• Understanding other RAs action on the application
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Challenges decision making Put resources where they count
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Mature
Minute
Emerging
End
Thanks you
Joey Gouws
Registrar of MedicinesMedicines Regulatory Authority
Department of HealthSouth Africa
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