2016/LSIF/FOR/005 Delivering New Treatments to Patients in Chinese Taipei

Transcription

1 2016/LSIF/FOR/005 Delivering New Treatments to Patients in Chinese Taipei Submitted by: Chinese Taipei Policy Forum on Strengthening Surveillance and Laboratory Capacity to Fight Healthcare Associated Infections and Antimicrobial Resistance Ha Noi, Viet Nam December 2016

2 Mei Fang Chen, Senior Reviewer Senior Reviewer, Division of Medicinal Products, Taiwan Food and Drug Administration (TFDA) 衛生福利部食品藥物管理署 Food and Drug Administration, Ministry of Health and Welfare 1

3 Disclaimer 藥求安全 The opinions expressed by Dr. Chen do not reflect official support or endorsement by Taiwan Food and Drug Administration 2

4 Outline Organization and Responsibility of TFDA Collaborative approaches and policies to New Drug Development Consultation system Case study 3

5 Establishment of TFDA 4

6 TFDA Organization Chart 5 5

7 The Role of TFDA 藥求安全 Protect Promote 6 Assure Quality, Safety, Efficacy of Medicinal Products Protect Promote Public Health Help to Speed the Development of Innovative Medicine and Drug Accessibility 6

8 衛生福利部食品藥物管理署 Food and Drug Administration, Ministry of Health and Welfare 7

9 NDA Approvals in Chinese Taipei 8

10 NDA approvals by therapeutic area in

11 Numbers 藥求安全 Anti-infection Drugs of New Drug License Antibiotics Antiviral drug 10

12 Outline Organization and Responsibility of TFDA Collaborative Approaches and Policies to New Drug Development Consultation system Case study 11

13 International Cooperation 藥求安全 US: TIFA UK: EOL MOU Poland: MOU Austria: MOU German: JD Regional Cooperation: APEC (LSIF RHSC) ICH IPRF IGDRP (International Generic Drug Regulators Programme) WTO (TRIPS TBT) Japan: Arrangement China: Cross- Strait Cooperation Agreement Philippines: MOU Singapore: ASTEP New Zeland: ANZTEP Australia: MOU 12

14 Direction of International cooperation of TFDA Regulatory convergence APEC: GRevP, GSP, combination products Technical Working Group of ICH, IPRF and RHSC: MRCT, B\R Assessment, vaccine, cell therapy products, Nanomedicine Regional cooperation International organization/c onference MOU, arrangement and agreement: Australia, Austria, China, EDQM, Japan, Philippine, UK IGDRP: information- and work-sharing arrangement (participants: Chinese Taipei, EU, Switzerland, Australia, and Canada) APEC, ICH, IGDRP, DIA, FIP 8 th DIA/IFPMA/TFDA Asia Regulatory Conference (ARC) FIP SIG BSE Workshop 2020 FIP World Conference 13

15 Cross-strait Cooperation Agreement on Medicine and Public Health Affairs Fields of Cooperation Both Parties agree to engage in exchanges and cooperation based on the principle of equality and reciprocity in the following fields: (1) Prevention and control of communicable diseases; (2) Safety administration and research and development of medicinal products; (3) Research and exchange in traditional Chinese medicine and safety administration in traditional Chinese medicinal materials; (4) Assistance for medical emergency; (5) Other fields mutually agreed upon by both Parties. 14

16 Drug Development Process and Review 藥求安全 15

17 Drug Discovery and Regulation Drug Lead IND application NDA application Approval 藥求安全 Consultation system and rolling review Discovery and Animal studies Act for the Development of Biotech and New Pharmaceuticals Industry GLP Animal studies Discovery and nonclinical studies GCP IRB/GCP inspection The quality of clinical drug ADR report Insurance of subjects and researchers Clinical trials Post action feedback New drug Biologics Botanic drugs Cell/gene therapy Generics cgmp PIC/S GMP NDA application and review Marketing GPvP/GPP ADR report Drug Injure Relief Safety surveillance (market) 16

18 Collaborative approaches Ministry of Economic Affair: Reduction of Tax Supra, Integration and incubation center (Si2C): for Tech-Transfer from Academia to Start-Up: Valuations, Funding, and Due-Diligence for New Drug and New Medical-Device Taiwan Food and Drug Administration and Center of Drug Evaluation: Consultation system and Rolling Review Cited from 17

19 Act for the Development of Biotech and New Pharmaceuticals Industry "Biotech and New Pharmaceuticals Industry" refers to the industry that deals in New Drugs and High-risk Medical Devices used by human beings, animals and plants. "New Drug" refers to a drug that has a new ingredient, a new therapeutic effect or a new administration method as verified by the central competent authorities. High-risk Medical Device" refers to a type of Class III medical devices implanted into human bodies as verified by the central competent authorities. 18

20 Procedures for Recognition of Biotech and New Pharmaceuticals Industry Application Ministry of Economic Affair Review Meeting Final decision Sponsor Taiwan FDA Check the product belong New drug or High risk medical device 19

21 NDA Review Strategy 20

22 Post act back(good review practice) NDA application(post act back) Explanation Filing letter Approval letter (eg. conditional approval) Within 2 months of getting the official letter Questions Attendance ( FDA 藥字第 號函釋 ) Tel- conference A written reply Face to face meeting Minutes 21

23 Outline Organization and Responsibility of TFDA Collaborative approaches and policies to New Drug Development Consultation system Case study 22

24 Facilitate innovative medicine industry -regulatory consultation system Consultation System Online Information Consultation by Request Active Consultation Industrial Communication Platform Domestic Innovative Consultation (Early Harvest Lists) National Research Program for Biopharmaceuticals (NRPB) 23

25 Domestic Innovative Consultation 24

26 Outline Organization and Responsibility of TFDA Brief introduction of manufacture process of biological products Points to consider of single use system Case study 25

27 Domestic Innovative Antibiotics in Chinese Taipei 太捷信 (nemonoxacin) 1.New Chemical Entity 2. Indication: Treatment of community-acquired pneumonia 3. First global approval (2014) 26

28 Nemonoxacin A medicine for cross strait cooperation. Receive the clinical trials in China and avoiding the redundant trials. The regulatory agents of two parties has telconference for the special issues. Nemonoxacin is also complied with Act for the Development of Biotech and New Pharmaceuticals Industry. 27

29 Nemonoxacin Priority review: Standard review time Review time Filing time 240 days 176 days 125 days Consultation system Consultation numbers Period to NDA application 3 (CMC issues),17(clinical issues) ~ Post -act back Number for In person meeting Issues 3 Clinical issues 28

30 Conclusion Accelerate the new drug development. Transparent and efficient review processes. 29

31 Thank You for Your Attention For more information Website is at: 30