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A New Paradigm for Medical Products Regulation in Taiwan Food and Drug Administration 2010. A New Paradigm for Medical Products Regulation in Taiwan Food and Drug Administration 2010. 09. 10 1

TFDA Organization Chart 2 2 TFDA Organization Chart 2 2

Pharmaceuticals Regulation in Taiwan Pre-Market Approval Research & Discovery Preclinical Testing IND/IDE GLP NDA/ Pharmaceuticals Regulation in Taiwan Pre-Market Approval Research & Discovery Preclinical Testing IND/IDE GLP NDA/ PMA IRB/GCP ADR/AE ★ Reporting Insurance GTP c. GMP 3 3 Market GPv. P ADR/AE Reporting Quality ★ADR/AE: adverse drug reaction/adverse event Post-Market Management Drug Injury Relief

Milestones on Drug Regulation 1980 1990 1982 GMP 2000 2001 Bridging Study Pivotal trial/ Milestones on Drug Regulation 1980 1990 1982 GMP 2000 2001 Bridging Study Pivotal trial/ Evaluation early phase trial in accordance with ICH E 5 1998 CDE 4 2010 PIC/S GMP 1999 c. GMP 1993 Local clinical trial 2010 2001 TDRF 2010 TFDA

Establishment of TFDA and Reform of Drug Review System v Enhancing quality, efficiency, and Establishment of TFDA and Reform of Drug Review System v Enhancing quality, efficiency, and transparency in reviewing of pharmaceuticals and medical devices v Fostering the development of biopharmaceutical industry v Promoting international harmonization on drug regulation 5

Transparency and Quality Assurance v Review quality assurance: QA/QC task force (2010. 03) v Transparency and Quality Assurance v Review quality assurance: QA/QC task force (2010. 03) v On-line Roadmap : for tracking review progress for sponsor (2010. 05) v Implementation of Good Review Practice (GRP) (2010. 07) v Disclosure of assessment report for NCE (2010. 08) 6

NDA/PMA Review Process Sponsor Application TFDA Review Team (TFDA Staff+ CDE) Global New, Botanical NDA/PMA Review Process Sponsor Application TFDA Review Team (TFDA Staff+ CDE) Global New, Botanical product, Biosimilar product, etc. Technical and administrative document, GMP/PMF Assessment report Consult with AC experts for special concern Advisory Committee Decision 7 7 Sponsor

Establishment of modern Clinical Trial Environment in Taiwan v Preclinical GLP inspection Ø Meet Establishment of modern Clinical Trial Environment in Taiwan v Preclinical GLP inspection Ø Meet international standard v GCP inspection Ø Follow ICH –E 6 GCP v Enhancement of the quality of IRB Ø international: SIDCER or FERCAP certified IRB Ø domestic : DOH audited 38 IRB v Training for clinical trial professional Ø Investigators, clinical research coordinators (CRC), clinical research associates (CRA), study nurses etc. v Improvement of clinical trial Infrastructure 8 8

Improvement of Clinical Trial Infrastructure v. Government funded Research Centers ØGrant $22 million (NT) Improvement of Clinical Trial Infrastructure v. Government funded Research Centers ØGrant $22 million (NT) in 2010 ØGeneral Clinical Research Center (GCRC): 11 sites ØCenter of Excellence: 5 sites ØCenter of Excellence for Cancer Research: 8 sites ØSite Management Organization (SMO) v. Qualified sites for IND/IDE: 128 teaching hospitals 9 9

MOU ★ between Taiwan Center of Excellence and International Pharmaceutical Company MOU assigning date MOU ★ between Taiwan Center of Excellence and International Pharmaceutical Company MOU assigning date Taiwan-international pharmaceutical company 2007 -09 -30 2009 -03 -25 National Taiwan University-Novartis 2009 -07 -16 National Taiwan University-Boehringer Ingelheim 2009 -11 -30 National Taiwan University-Pfizer 2010 -05 -13 Taipei Veterans General Hospital-GSK 2010 -08 -31 Chung Gung Medical Hospital-Novartis 2010 -09 -01 10 National Taiwan University-GSK China Medical University Hospital -Novartis ★MOU: Memorandum of Understanding

Taiwan Global Trials Sponsored by International Companies Ranking   Case number (phase I-III) 1 Taiwan Global Trials Sponsored by International Companies Ranking   Case number (phase I-III) 1 A 49 2 B 35 3 C 31 4 D 26 5 E 26 6 F 21 7 G 21 8 H 19 9 I 19 10 J 17 11 11 International Company Roche 15 L 15 12 source: 2007~2010 Q 2, CDE database

Clinical trials conducted in Asia as of July 12, 2010 East Asia Southeast Asia Clinical trials conducted in Asia as of July 12, 2010 East Asia Southeast Asia Taiwan 1792 India 1331 Singapore 692 Japan 1523 Pakistan 150 Thailand 717 Korea Republic of 1907 Bangladesh 76 Philippines 393 China 1664 Nepal 13 Malaysia 326 Hong. Kong 519 Sri Lanka 14 Indonesia 116 Korea, Democratic People’s Republic of 0 Afghanistan 7 Cambodia 15 Vietnam 70 Myanmar 4 Total 12 7, 405 Total 1, 591 Total 2, 333 Source: http: //www. clinicaltrials. gov 12

Clinical Trial Environment in Excellent Centers Country Taiwan Korea China Population 22. 9 M Clinical Trial Environment in Excellent Centers Country Taiwan Korea China Population 22. 9 M 48 M 1300 M Cost 2~3 Months 8~12 Months Approval of Protocol Investigator Data Quality Medical staff Patient retention 1~1. 5 Months (US trained) source: Trial. Trove, May 2009 13

International Cooperation v Memorandum of Understanding with Australia v EOLs ★ : GMP inspection International Cooperation v Memorandum of Understanding with Australia v EOLs ★ : GMP inspection & AE information sharing with USA, EU, and Switzerland v TCP ★ ISO 13485 audit report sharing with 12 EU Notified Bodies v Application of PIC/S membership v APEC (LSIF, ISTWG), ICH-GCG and etc. v Future works: Ø Promote collaboration with Japan, China and Korea, Singapore and Thailand Ø Participate WHO and related organization or meetings, such as ICDRAs ★ 14 ★EOLs: exchange of letters ★ ICDRAs: International Conference of Drug Regulatory Authorities 14 ★TCP: Technical Cooperation Program

Cross-Strait Cooperation in Clinical Trial v. ECFA , Signed Between China and Taiwan (2010. Cross-Strait Cooperation in Clinical Trial v. ECFA , Signed Between China and Taiwan (2010. 06), opens a favorable cross-strait interaction mechanism and will improve the basis of promoting Taiwan’s cooperation with other countries v. Cross-Strait cooperation on new drug research and clinical trial (in progress) ★ ★ECFA: Economic Cooperation Framework Agreement 15

Major Breakthroughs (I) Relaxation of CPP Non-CPP 1 -CPP 2 -CPP Expected review time Major Breakthroughs (I) Relaxation of CPP Non-CPP 1 -CPP 2 -CPP Expected review time 720 days ( 2 years): 360 days plus GXP inspection 360 days Expected review time 300 days Expected review time 200 days 1. Early phase clinical trials in Taiwan 2. REMS/RMP 1. pivotal clinical trial in Taiwan 1. REMS/RMP if necessary 2. REMS/RMP if necessary ★CPP: Certificate for Pharmaceutical Product from 10 advanced countries ★REMS/RMP: Risk Evaluation and Mitigation 16 Strategy/ Risk management plan 16 ★ GXP: GCP, GLP, GMP 16

Major Breakthroughs (II) New Review Tracks Priority Review (unmet medical needs) Abbreviated Review (FDA Major Breakthroughs (II) New Review Tracks Priority Review (unmet medical needs) Abbreviated Review (FDA + EMA approved) Accelerated Review (For new agents with high industrial value) Expected review time: 180 days Expected review time: 150 days Priority review: Full documents Partial review, focused on bridging data, REMS, PSUR, etc. Expected review time: 180 days 17 17 Accelerated Review: Full documents Verification Review (Future with MOU) Verification based on reference agencies’ assessment r e p o r t s

Major Breakthroughs (III) CTN Scheme v Multi-national clinical trials approved by advanced country v Major Breakthroughs (III) CTN Scheme v Multi-national clinical trials approved by advanced country v One of Taiwan’s medical centers participated v Refer to Australian CTN scheme to accelerate the protocol review process v Implement since Aug 18, 2010 ★CTN: Clinical Trial Notification 18

Major Breakthroughs (IV) Biopark Cooperation v To plan the TFDA campus and establish the Major Breakthroughs (IV) Biopark Cooperation v To plan the TFDA campus and establish the Biotech Industry Consultation and Education Resource Center in Nangang National Biotechnology Research Park 19

Future Prospect v To create friendly regulatory environment v To promote excellent R&D infrastructure Future Prospect v To create friendly regulatory environment v To promote excellent R&D infrastructure for innovative medical products 20 Quality Efficiency International Transparency Harmonization 20

Taiwan: Centrally Located in East Asia Beijing 3’ 00 Seoul 2’ 20 Tokyo 2’ Taiwan: Centrally Located in East Asia Beijing 3’ 00 Seoul 2’ 20 Tokyo 2’ 50 Shanghai 1’ 20 Osaka 2’ 15 Chongqing 3’ 00 Guangzhou 1’ 30 Hong Kong 1’ 40 Bangkok 3’ 45 Taiwan Manila 2’ 00 Ho Chi Minh City 3’ 20 Kuala Lumpur 4’ 35 Singapore 4’ 20 Jakarta 5’ 00 21 Sydney 8’ 50

Thank You for Your Attention 22 22 Thank You for Your Attention 22 22