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2 December 2010 Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience Dr Daniel Tan Director Health Products Regulation Group Health Sciences Authority Copyright HSA 2009 1 Overview ¾ Mission ¾ Background ¾ Regulatory Principles ¾ Evaluation Routes ¾ Data Requirements ¾ Regulatory Process ¾ Application Statistics Copyright HSA 2010 Mission Wisely regulate health products Secure the nation’s blood supply HSA Serve the administration of justice Copyright HSA 2010 Risk-based evaluation based on international regulatory practice and scientific standards Safeguard public health Ensure medicinal products marketed in Singapore meet the quality, safety and efficacy standards Background Licensing of medicinal products for sale & supply in Singapore Legal requirements under the Medicines Act Drug registration first implemented in 1987 Establish high standard regulatory framework for health products 85% applications meet target turnaround time Copyright HSA 2010 Regulatory Principles Risk‐based approach Copyright HSA 2010 Pre-market Evaluation ¾ Depth of evaluation varies following a risk& confidence-based approach ¾ Three evaluation routes allowing flexibility yet ensuring robustness in the registration system ¾ In-house capabilities complemented by external experts and advisory committee Copyright HSA 2010 Application Type Pre-market approval • New drug application (NDA) • Generic drug application (GDA) Post-market variation • Major variation application (MAV-1) • Major variation application (MAV-2) • Minor variation application (MIV-1) Post-market variation via notification • Minor variation application (MIV-2) Copyright HSA 2010 Innovation – HSA’s 3-route System Pre-Market Evaluation Routes for New Drugs Product yet to be approved by any regulatory agency Presubmission consultation Product approved by one drug regulatory agency Product approved by reference regulatory agencies* Full Evaluation Abridged Evaluation Verification Full evaluation & Regulatory Decision Abridged evaluation & Regulatory Decision Evaluation & Regulatory Decision based on assessment report by benchmark regulatory agency Risk-Based Approach * Reference regulatory agencies refer to US FDA, Health Canada, UK MHRA, Australian TGA, EMEA Copyright HSA 2010 8 Evaluation Routes (NDA & MAV-1) Full Abridged Verification Copyright HSA 2010 No prior approval by any drug regulatory agency Approved by one drug regulatory agency Approved by two reference agencies Full quality, nonclinical, & clinical Internal & external evaluation Full quality & abridged clinical Internal & external evaluation Reference agency assessment report Internal evaluation only Evaluation: 210 WD Reg Decision: 60 WD Total: 270 WD Evaluation: 120 WD Reg Decision: 60 WD Total: 180 WD Evaluation: 40 WD Reg Decision: 20 WD Total: 60 WD • Biopharmaceutic study reports • PK study reports • PD study reports • Toxicology reports • Clinical study reports (Phase I, II, III) • Post-marketing reports (if applicable Copyright HSA 2010 • Chemistry, manufacturing & control data • Summaries (biopharmaceutics,PK,PD, toxicology, efficacy, safety) • Clinical study reports (Phase II & III) • Post-marketing reports or study report (Phase IV, if applicable) verification • Chemistry,manufacturing & control data abridged full Data Requirements (NDA/MAV-1) • Chemistry, manufacturing & control data • Summaries (biopharmaceutics,PK,PD, toxicology, efficacy, safety) • Clinical study reports (Phase II & III) • Post-marketing reports or study report (Phase IV, if applicable) • Assessment report from 2 reference agencies Evaluation Routes (NDA & MAV-1) Full Abridged Verification Copyright HSA 2010 No prior approval by any drug regulatory agency Approved by one drug regulatory agency Approved by two reference agencies Full quality, nonclinical, & clinical Internal & external evaluation Full quality & abridged clinical Internal & external evaluation Reference agency assessment report Internal evaluation only Evaluation: 210 WD Reg Decision: 60 WD Total: 270 WD Evaluation: 120 WD Reg Decision: 60 WD Total: 180 WD Evaluation: 40 WD Reg Decision: 20 WD Total: 60 WD • Biopharmaceutic study reports • PK study reports • PD study reports • Toxicology reports • Clinical study reports (Phase I, II, III) • Post-marketing reports (if applicable Copyright HSA 2010 • Chemistry, manufacturing & control data • Summaries (biopharmaceutics,PK,PD toxicology, efficacy, safety) • Clinical study reports (Phase II & III) • Post-marketing reports or study report (Phase IV, if applicable) verification • Chemistry,manufacturing & control data abridged full Data Requirements (NDA/MAV-1) • Chemistry, manufacturing & control data • Summaries (biopharmaceutics,PK,PD toxicology, efficacy, safety) • Clinical study reports (Phase II & III) • Post-marketing reports or study report (Phase IV, if applicable) • Assessment report from 2 reference agencies Evaluation Routes (NDA & MAV-1) Full Abridged Verification Copyright HSA 2010 No prior approval by any drug regulatory agency Approved by one drug regulatory agency Approved by two reference agencies Full quality, nonclinical, & clinical Internal & external evaluation Full quality & abridged clinical Internal & external evaluation Reference agency assessment report Internal evaluation only Evaluation: 210 WD Reg Decision: 60 WD Total: 270 WD Evaluation: 120 WD Reg Decision: 60 WD Total: 180 WD Evaluation: 40 WD Reg Decision: 20 WD Total: 60 WD • Biopharmaceutic study reports • PK study reports • PD study reports • Toxicology reports • Clinical study reports (Phase I, II, III) • Post-marketing reports (if applicable Copyright HSA 2010 • Chemistry, manufacturing & control data • Summaries (biopharmaceutics, PK,PDtoxicology, efficacy, safety) • Clinical study reports (Phase II & III) • Post-marketing reports or study report (Phase IV, if applicable) verification • Chemistry,manufacturing & control data abridged full Data Requirements (NDA/MAV-1) • Chemistry, manufacturing & control data • Summaries (biopharmaceutics, PK,PD toxicology, efficacy, safety) • Clinical study reports (Phase II & III) • Post-marketing reports or study report (Phase IV, if applicable) • Assessment report from 2 reference agencies Evaluation Routes (GDA) Abridged Approved by one drug regulatory agency Full quality & BE (POMs in oral dosage form) Internal evaluation. Total: 240 WD Verification Approved by one reference agency Reference agency assessment report Internal evaluation. Total: 120 WD *WD: working days Copyright HSA 2010 • Chemistry, manufacturing & control data • Bioequivalence studies (for POMs in solid oral dosage forms) Copyright HSA 2010 verification abridged Data Requirements (GDA) • Chemistry, manufacturing & control data • Bioequivalence studies (for POMs in solid oral dosage forms) • Assessment report from reference agency Evaluation Routes (GDA) Abridged Approved by one drug regulatory agency Full quality & BE (POMs in oral dosage form) Internal evaluation. Total: 240 WD Verification Approved by one reference agency Reference agency assessment report Internal evaluation. Total: 120 WD *WD: working days Copyright HSA 2010 • Chemistry, manufacturing & control data • Bioequivalence studies (for POMs in solid oral dosage forms) Copyright HSA 2010 verification abridged Data Requirements (GDA) • Chemistry, manufacturing & control data • Bioequivalence studies (for POMs in solid oral dosage forms) • Assessment report from reference agency Regulatory Process (NDA/MAV) Pre-submission Consultation Clinical Peer Review Advisory Committee Submission of application Quality Peer Review Regulatory Outcome Screening Evaluation Final Regulatory Decision Acceptance of application Triage Queries Copyright HSA 2010 Regulatory Process (GDA) Pre-submission Consultation Quality Peer Review Submission of application Screening Acceptance of application Copyright HSA 2010 Clinical Peer Review Queries Regulatory Outcome Quality Peer Review Final Regulatory Decision Evaluation NDA Approvals by Evaluation Route 100% 91% 90% 86% 84% 83% 80% 70% 60% Full 50% Abridged 40% Verification 30% 20% 10% 13% 10% 7% 7% 3% 2% 10% 4% 0% 2008 Copyright HSA 2010 2009 2010 (up till Oct) Average % by route Regulatory Decision Regulatory Outcome Application withdrawal Non-approvable due to major deficiencies Applicant’s response Satisfactory Unsatisfactory Application withdrawal Approval Product Licence Copyright HSA 2010 Rejection Intermediate Final Approvable subject to conditions NDA Approval Timelines 250 200 150 100 50 0 2008 2009 Full Abridged 2010 (up till Oct) Verification N.B. Approval timelines in working days (excluding stop‐clock time) Copyright HSA 2010 Conclusion Resources are always limited in most regulatory agencies Adopting a risk based approach to triage drug applications Titrate the evaluation workload by levaraging on reference agencies assessment reports Managing Access to important medicines without prolonging timelines For small markets like Singapore, this unique system of drug evaluation, ensures that market entry of drug products is vetted in an efficient manner without compromising on stringent standards for safety and efficacy. Copyright HSA 2010 24 Thank you Copyright HSA 2010
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