Challenges and Opportunities in the Global Regulatory Environment

Transcription

1 Challenges and Opportunities in the Global Regulatory Environment Diane Zezza, Ph.D. Novartis Pharmaceuticals Corporation WCBP 2013 January 29, 2013

2 Diversity and Global Landscape Development Registration Product Lifecycle Time Zones Cultures Languages Within/across companies: Multiple centers, sites, working across geographies 2 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

3 Global Regulatory Landscape Some regulatory harmonization ICH Country Specific Requirements FDA, Health Canada Regional Requirements ASEAN Pharmacopoeia standards Other standards ISO Many Regulatory Authorities with often different requirements 3 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

4 Complexities of Global Clinical Trials Different clinical trial application content Different application review timelines Changes throughout development Increasing knowledge Refining process and controls Significant global complexity 4 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

5 Complexities of Global Clinical Trials Example: Logistics of Clinical supplies Continuity Comparators Labeling Manufacture/packaging sites Sourcing restrictions Import requirements GMP Inspections Global flexibility may be limited 5 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

6 Global Registration Requirements Progress on harmonized requirements some aspects of License Application CTD May be differences in technical content Methods or acceptance criteria i.e USP, EP May be regional or country specific requirements Acceptance criteria Requirements may be evolving in some countries May need approval in one country before register or approve in another country May need additional local clinical trials as part of registration Global registration process can take years dossier content drifts 6 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013 Global dossier content not possible

7 Global Registration Requirements Example Specifications - Impurities Same product and data package submitted to multiple countries Different reviewers, different outcomes on Acceptance Criteria - More reliance on process capability - More reliance on clinical batch experience - More receptivity to set interim limits Outcome: Multiple approved versions of Specifications for same global product Many versions of control for same product 7 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

8 Post-approval Product Lifecycle Global post-approval change requirements not harmonized Change control process drives compliance Significant dossier evolution over time Additional challenges with older approved products Complexity increases as product ages 8 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

9 Post-approval Product Lifecycle Example: Requirements and supply logistics Comparability requirements may vary Can take months to approve major change globally Some countries approval times are not predictable Managing dual global inventory of pre- and post-change products Managing country-specific post-change product introductions Delays can lead to potential drug shortage Global supply coordination is complex and lengthy 9 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

10 Innovation, New Technologies, Novel Therapies Higher level of complexity Requirements may be unclear, evolving, undefined May require multiple interactions with Health Authorities May require bringing together multiple groups within and Agency for alignment Global requirements may be different Regulatory pathway may have less predictability 10 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

11 Innovation, New Technologies, Novel Therapies Example: Products components and classification xx x Components and classification likely not globally harmonized 11 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

12 Global GMPs and Facility Inspections GMPs not globally harmonized May have different interpretation by different inspectorates worldwide Some harmonization activities FDA/EMA Joint GMP Inspections PIC/S Mutual Recognition across some Agencies Multiple inspections of same facility and same product by different Agencies Opportunities for further harmonization 12 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

13 Global GMPs and Facility Inspections Example: New License Application submitted globally Multiple inspections of same facility and same product by different Agencies Inspections will happen within 1-2 year timeframe Significant time for regulatory Agencies and company to determine site GMP compliant Opportunities for further harmonization 13 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

14 Quality by Design Leads to increased process and product knowledge Benefits to science-based, risk-based well accepted Harmonized ICH guidances as framework Q8, 9, 10, 11 Country-specific interpretations and requirements Differing experience across countries Divergence of approved dossier content Opportunities for further harmonization 14 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013

15 Conclusions Global regulatory landscape is diverse Found solutions to address complexity Opportunities to evaluate standards to strive toward further global harmonization 15 Diane Zezza, Novartis Pharmaceutical Corporation WCBP 29 Jan 2013