regulatory updates in taiwan
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Regulatory Updates in Taiwan
Hwei-Fang Cheng, Ph.D.
Deputy Director-General
Taiwan FDA
8th Joint Conference of Taiwan and Japan on Medical Products Regulation
Oct. 15, 2020
Outline
02
Medical Products Management01
03Collaboration with Japan
04Future Prospects
2
Response to COVID-19
3
Current Regulatory Framework for Cell and Gene Therapy in Taiwan
Medical productMedical technique
CommercializationCustomization
Cell/ gene/ tissue engineering
Cell (autologous)6 categories
IND (Clinical Trial) /NDA
Treatment Plan
Distributed by pharmaceutical
companies
Performed by registered physician in recognized
medical institute
Approved 48 Cell therapy technique
Approved 68 Cell therapy IND
Approved 13 gene therapy IND
updated to Aug. 31, 2020
Pharmaceutical Affairs Act &Regenerative Medicinal Product Act (Draft)
Regulation Governing the Application of Specific Medical Examination Technique and Medical Device
Government
Industry Academia
Guideline for bridging medical technique to medical products (Draft) Aug 28, 2020
3
4
Innovative cell therapy productsCLS2702C/CLS2702D• (Autologous) Oral Mucosal Cell
Sheet Transplantation• Esophageal cancer • Phase III ongoing
NK+NKT• non-small cell lung
cancer• Phase I ongoing
PB103 (allogeneic NK cell)• non-small cell lung cancer• Phase I/IIa ongoing
Welgenaleucel (UWC19)
• Relapsed or refractory B-cell non-hodgkin's lymphoma
• Phase I/II ongoing
Innovative CAR-T therapy products
Evolving Domestic Innovative Regenerative Medicine Products
ADCTA-SSI-G1 (Dendritic cell/tumor antigen)
• glioblastoma multiforme• Phase III ongoing
CAR-T Products under development
(Examples)
4
5
Why biosimilar is important?
MOST OF THE TOP SALES DRUGS ARE BIOLOGICS
THE PATENTS OF HIGHLY SUCCESSFUL BIOLOGICS ARE SET TO EXPIRE OVER THE NEXT 10 YEARS
「BIOSIMILAR」 HELP TO STABILIZE THE FINANCES OF NATIONAL HEALTH INSURANCE (NHI)
5
6
3
1
4
2 5
6Harmonize with International Regulations
What we had done
Transparent review considerations(provide guidance)
Provide counseling mechanism
Establish multiple communication pathways, increase public awareness
Improve review quality and review efficiency
6
7
Current status of biosimilar drugs in Taiwan
USA(28)
• Adalimumab• Bevacizumab• Infliximab• Rituximab• Trastuzumab• Etanercept• Epoetin alfa• Filgrastim• Pegfilgrastim
EU(58)
• Adalimumab• Bevacizumab• Infliximab• Rituximab• Trastuzumab• Etanercept• Enoxaparin sodium • Epoetin alfa• Epoetin zeta• Filgrastim• Follitropin alfa• Insulin aspart• Insulin glargine• Insulin lispro• Pegfilgrastim• r-Somatropin• Teriparatide
Korea(25)
• Adalimumab• Infliximab• Rituximab• Trastuzumab• Etanercept• Darbepoetin alpha• Epoetin alfa• Insulin glargine• r-Somatropin• Teriparatide
Taiwan(17)
• Adalimumab• Bevacizumab• Infliximab• Rituximab• Trastuzumab• Insulin glargine• Filgrastim• Pegfilgrastim• r-Somatropin
Developing biosimilar in Taiwan• Trastuzumab (Phase III / Phase I)• Tocilizumab (Phase I)• Omalizumab (Phase I)• Epoetinum alfa (Phase III)• Filgratim (Pre-IND)
2020.10.06 update
7
8
NCE Serious disease
Unmet medical need
children's ethnic groups /or
prevalence rate less than 5/10,000
Suitable
Review process
Priority Review ~240 days
Priority review voucher (Pediatric)
Incentives
CPPCertificate of Pharmaceutical exempt if domestic clinical trials had executed.
clinical trialsrelaxation by case.
BSENo requirement of Bridging Test Evaluation prior application.
post-marketingactual domestic consumption and estimated domestic demand for use must be report.
7 Rare disease
New Expedite Review Program: Pediatric or Rare disease Designation
Nov. 18, 2019
1 Pediatric
16 application
(Designated)
(Designated)
8
9
IND Applications in Taiwan by Local/MRCT Type
0
50
100
150
200
250
300
350
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
2411 21
34 38 47 4633
58 57 5135
5540 36
1022
2016 9
17 1720
23 27 29
29
2935
21
86100
127
155140
129111
185
177190
222
210
214 234
229
TW single site TW multicenter MN multicenter
205
187193
174
238
258
120
133
168
274
302
274
298306
286
No.
of A
pplic
ations
MRCT :
80%
9
10
IND Applications in Taiwan by Study Phases
0
50
100
150
200
250
300
350
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
14 12 10 11 18 18 1534 29 38 43 49 45 38 42
33 32 46 4660
44 53
6864
7493 94
87 90 9569 86
106132 95
110 90
121 138
139
137 121 141168
127
43
6
16
14 2116
1527
23
29
1025
13
22
Phase I Phase II Phase III Phase IV/Others
120133
168
205
187 193
174
238258
274 274
302 298309 286
No.
of A
pplic
ations
10
01
02
03
04
05
Real World Data/Evidence(RWD/RWE) GuidanceBasic
Consideration
Electronic Health
Record
Study design using
RWD
Relevance and
Reliability
Application and
Submission
Instruction
Basic Considerations in Supporting Drug Research and Development with Real-World Evidence
Use of Electronic Health Record Data in Clinical Trials/ Investigations Guidance (draft)
RWE study designs- considerations and key points for pragmatic clinical trial (draft)
Real World Data Quality Evaluation-Relevance and Reliability consideration (draft)
RWD/RWE application and submission guidance (drafting)
2020.04.29
2020.08.28
2020.10.13
2020.07.22
Sapropterintablets
Oral Ketoconazole, Hepatotoxicity
Case study 1 Case study 2
Alteplase
Case study 3
11
12
Generic Drug Policy
Promotion
of generic
Comprehens
ive
counseling
Approval rate
Compliance
rate
Through these efforts, our export of generic drugs has also increased. In 2019, the
export of preparations increased by about 25%
compared with 2018.
Improve the accessibility of generic drugs
Encouraging the development of “Competitive Generic” to lower drug cost than the brand drug
Promote generics through media, brochures and visits to pharmaceutical to improve the consumer's recognition
12
13
Implementing E-System13
ICH E2B(R3)
Implemented on 1st September,
2020
Adverse Event Reporting System
Track-and-Trace System
eCTD v3.2.2
Technical Document(M1~M5)
Under-Construction
E-Submission
Paperless
Efficiency
14
Establishing Medical Devices Act
Set statutory framework
2014
Complete initial draft
2015
Announce revised draft and communicate with the Legislative Yuan and industry
2016Promote legislative process
2017
Establish the Medical Devices Act to be internationally harmonized and meet domestic needs
Future
2018-2019Conduct article-by-article deliberation and inter-party negotiation
14
2020Promulgate the Act via Presidential order, develop and formulate relevant and complementary regulations and announcements
Digital Health Medical Devices
Updated Digital Health Medical Device Guidelines:
1. Guideline of Cybersecurity for the Manufacturers
2. Q&A for Intelligent Technology Medical Device Registration
3. Artificial Intelligent / Machine Learning-Based Software as a Medical Device Registration Guideline
(2019.11.21)
(2020.5.15)
(2020.9.23)
15
Approved Digital Health Medical Devices
Robotic
Exoskeleton
Diabetic Retinopathy
screening system
AI-assisted solutions for
Diabetic Retinopathy
identification.
Powered Exoskeleton
Assist people with lower
limbs weakness to walk with
stronger posture.
Diabetic retinopathy screening system
http://www.freebionics.com.tw/en/freewalk
https://www.acer-healthcare.com/veriseedr
Free Bionics Taiwan Inc.
Acer Healthcare Inc.
16
17
Response to COVID-19
Drug Supply
Database
Platform
Guidelines
Maximize
Production
Restrict
Exportation
Protect trial
recipants’
right and
safety
Emergency Use
Authorization
Fast Track
Clinical Trial
Review Process
Registration
Optimization
Measures
Consultation
Vaccine
DRUG SUPPLYSANITIZER PRODUCTS
CLINICAL TRIALSDRUG
DEVELOPMENT
17
18
Assistance for Manufacturers
Response to COVID-19
1
2
4
3
Management of Stockpiles
Offer Guidance & Consultation
Emergency Use Authorization
Relaxation of Regulations
• Announced technical guidance on 4 different medical devices
• Approved 69 applications of special manufacturing
• Approved 104 applications of special import
18
TFDA Virtual Meeting on COVID-19
Actions taken by regulatory authorities to prevent potential drug shortages or supply disruptions
Actions taken by regulatory authorities to satisfy the increasing demands for alcohol-based sanitizer products and PPE
Actions taken by regulatory authorities to fulfill the needs for COVID-19 diagnostic test kits from regulatory perspective
19
Collaboration with Japan
Progress for the Pharmaceutical Working Group
Progress for the Medical DevicesWorking Group
• Renewed the Q&A proposedby industries from both sidesand published it for thebenefit of stakeholders
• Updated the regulationsrelating to cybersecurity orartificial intelligence medicaldevices for both sides
• Sharing and comparing reviewpoints for further cooperation,including the pilot project onproduct review.
• Established the InformationSharing model and Directcontact of post-marketingsurveillance information
20
Progress for the QMS Working Group of Medical Devices
2014
2017
21
2018
2019
2020
Establishment of QMS WG 2nd Joint Conference of Japan and Taiwan on medical product regulation
Monitored audit for TUV SUD PS Japan ;MoC has been signed in November 30 ;
Start of Phase III after signing of MoC
Abbreviated mode is accepted by Taiwan and Japan authority in review of QMS
The utility of abbreviated mode is continuing and related questions and answers are gathering and sharing by Taiwan and Japanauthority in the review of QMS.
22
Taiwan Food and Drug Administration Ministry of Health and Welfare
Future Prospects
To Establish Forward-looking Legislation
To Complete Accessible Information Platform
To Establish Professional Review Team
To Optimize Quality Compliance and Management
To Enhance International Regulatory Collaboration
To Provide Efficient Communication and Services
22
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