Sept. 29, 2008 Herng-Der Chern, M.D., Ph.D. Executive Director Center For Drug Evaluation, Taiwan

Transcription

1 Partnership in Harmonization with a Proposal of APEC Pharmaceutical Evaluation Report (PER) Scheme from Taiwan Sept. 29, 2008 Herng-Der Chern, M.D., Ph.D. Executive Director Center For Drug Evaluation, Taiwan

2 PER Scheme 1979~1999 Norway Finland Sweden Austria Switzerland 2/19

3 PER Scheme 1979~ EFTA as secretariat Czech Republic Norway Italy Switzerland Finland Austria Sweden Germany Canada Hungary Netherland Ireland Iceland Australia UK New Zealand South Africa 3/19

4 PER Scheme 1979~ EFTA as secretariat Netherland Norway Italy Finland Austria Sweden Hungary Germany Ireland Czech Republic UK EU Canada Switzerland Iceland South Africa Australia New Zealand 4/19

5 Why PER Scheme Needed Limited Resource: Every agency duplicating unlinked evaluation in parallel or in sequence Rational for the Double Evaluation Compare and Contrast for quality assurance Open Exchange System involved Industry: right to see, refuse to release, comment and translation obligation Partnership in Harmonization for dialogue, training of all stakeholders 5/19

6 Operation of the PER Scheme (I) Circulation of approved product list Standardized assessment reports could be requested for products up to 2 years from date of approval Industry would translate and allow to comment Receiving country gives feedback to the donor country without obligatory approval 6/19

7 Operation of the PER Scheme (II) Supervised by PER Committee which meets at least once a year EFTA offered administrative support Rule and guidelines harmonized with EMEA as far as possible 7/19

8 PER Scheme Benefits Shortened assessment time: mean 40 working days Reduced resource requirements of requesting authorities by 30% Unquantifiable improvement in the quality of evaluation Strong support from industry: rejected once out of 600 request for reports exchange 8/19

9 Why PER Scheme Closed in 1999? EU took the spirit of PER Scheme but become a closed exchange system in NDA mutual recognition, joint training, etc. EFTA changed priority in supporting 9/19

10 Why Revival of PER Scheme Proposed by Taiwan since 2006? Similar need for countries other than EU Globalization in drug development, registration and marketing especially after ICH: Think Globally Ethnic concerns, risk management plan and critical path initiatives for regulatory science call for partnership in harmonization : Act Locally 10/19

11 Why not just use FDA/EMEA online report? Very good references but can be better with PER Scheme as some agencies may approve earlier FDA/EMEA don t publish negative report, black out or adapted the published report Need another Regulatory Voice especially considering ethnic factors and different local risk-benefit decision 11/19

12 Independent Asian Regulatory Voice Gefitinib : effective for Asian in ISEL trial Rosuvastatin : half the initial and max. dose Alosetron disapproved before Mibefradil worldwide withdrawal Carbamazepine: HLA-B*1502 and Steven- Johnson syndrome labeling warning Drug X approved by FDA/EMEA but not in Chinese Taipei as patients are not likely to check weekly liver function for hepatotoxicity 12/19

13 Potential Benefit for Revival of PER Scheme De-regulate the requirement of CPP (Certificate of Pharmaceutical Product) Promote risk-based good review practice with limited resources Exchange assessment reports of IND/NDA/Bridging Study Evaluation/Safety/GCP Inspection to avoid duplication in assessment Win-Win situation for public health and good business 13/19

14 Barriers to the Adoption of PER Scheme in APEC Economies A heterogeneous region with different harmonization initiatives like ASEAN, EAPRS (China, Korea, Japan), APEC LSIF, APEC Network of Pharmaceutical Regulatory Sciences, PAHO and many bilateral regulatory agreements No strong administrative support for Revival of PER Scheme Different level of readiness and resources for good review practice Lack of strong leadership in regulatory harmonization 14/19

15 Test the Water Proposed by Taiwan in many international conferences like CMR Geneva meeting in Feb, 2006 and Dec., 2007, 2007 Atlanta DIA meeting, Taipei APEC Network meeting and 2008 Kula Lumpur IFPMA meeting Interest from CMR, WHO, Swissmedic. (Switzerland), TGA (Australia), MPA (Sweden), BPA (Taiwan), Roche, Novartis, GSK, AstraZeneca, PhRMA, etc. Idea supported by 2 past PER Scheme chairpersons and willing to help 15/19

16 Recommendations and Conclusions in 2008 APEC LSIF (Life Science Innovations Forum) Regulatory Harmonization session LSIF recommends that Ministers and Leaders endorse and support the establishment of the APEC Harmonization Centre (by Korea) LSIF supports the proposed feasibility study of the exchange between economies of evaluation reports (proposed by Taiwan) LSIF agrees to established a Regulatory Steering Committee within the LSIF structure (proposed by Canada) 16/19

17 Suggestion to APEC Identify a suitable organization for administrative support like Korea AHC or IFPMA? Start a pilot project from a few regulatory agencies of APEC economies first, especially involving the ones once in PER Scheme like Canada, Australia, Japan, Korea, Singapore, Taiwan and etc. Work closely with ICH-GCG, ASEAN, EMEA, EAPRS, PAHO, etc. 17/19

18 Revival of PER Scheme 18/19

19 Welcome! 19/19