regulations of vaccine development in taiwan · pharmacovigilance of influenza vaccine monitoring...
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Regulations of Vaccine
Development in Taiwan
Division of Medicinal Products, Taiwan Food and Drug Administration (TFDA)
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Outline
Organization and Responsibility of TFDA
Lifecycle Management of Vaccine
Regulations for Pandemic Vaccine
Prospects
Consultation System
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Establishment of TFDA
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The Role of TFDA
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Protect
Promote
Public Health
Protect
Assure Quality, Safety, Efficacy
of Medicinal Products
Promote
Facilitate the Development of
Innovative Medicine and Speed Drug
Accessibility
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TFDA Organization Chart
CDE is a nongovernmental organization commissioned by the TFDA to evaluate technical dossiers of IND and NDA application
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License Numbers of Drugs in 2016
Total license: 24,978
Taiwan Market •Population: 23 millions •160~240 thousand newborn babies/yr •16~18 million doses/yr released by TFDA •11 million doses/yr for EPI
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Licensed Vaccines in Taiwan Approved Vaccine
Domestic
• Bacille Calmette-Guerin vaccine (BCG) • Mouse brain-derived JE vaccine • Seasonal flu vaccine • Tetanus toxoid
Import • Hepatitis B vaccine (HepB) • DTaP-Hib-IPV 5 in 1 • DTaP • Inactivated polio vaccine (IPV) • Pneumococcal vaccine (PV) • Varicella vaccine (Varicella) • Measles, mumps and rubella vaccine(MMR) • Cell –based JE vaccine • Seasonal flu vaccine
Vaccinations for The Expanded
Program on Immunization (EPI)
Others
• Rotavirus vaccine (Rotavirus) • Hepatitis A vaccine (HepA) • DTaP-IPV-HepB-Hib 6 in 1 • DTap-IPV 4 in 1 • Rabies vaccine (Rabies)
HPV Vaccine • Human Papillomavirus vaccine Type 16 and 18 • Quadrivalent Human Papillomavirus (Types 6,11,16,18) • Human Papillomavirus 9-valent Vaccine, Recombinant
Specific Import
Specific Import by CDC
• Typhoid fever vaccine (Typhoid) • Yellow fever vaccine (YF) • Meningococcal C conjugate vaccine (Men C_conj) • Others (Vaccines in Delay or Shortage)
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Outline
Organization and Responsibility of TFDA
Lifecycle Management of Vaccine
Regulations for Pandemic Vaccine
Prospects
Consultation System
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Life Cycle Management of Vaccine
Consultation
ADR & Product Defect Reporting
Registration GLP GCP
GPvP
IRB
GLP: Good Laboratory Practice GCP: Good Clinical Practice IRB: Institutional Review Board SUSAR: Suspected Unexpected Serious Adverse Reactions GMP: Good Manufacturing Practice ADR: Adverse Drug/Device Reaction GPvP: Good Pharmacovigilance Practices GDP: Good Distribution Practice GVP: Good Vigilance Practice GPP: Good Pharmacy Practice RMP: Risk management plan Lot release: Each lot must be tested for purity, potency, identity, and sterility
Pre-clinical Studies
IND Clinical Trial
Post-market Surveillance
Basic Research
Product Development
NDA
Market licensing production
GDP
SUSAR Reporting
Insurance
PICS/GMP
RMP
Drug injury relief
GPP
Pre-Market Approval Post-Market Control
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Lot release
Supplement (post-licensure changes, i.e., new indication or facility…)
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Legislation and Regulation
Legislation and Regulations on Vaccine
Law Pharmaceutical Affairs Act Medical Care Act
Regulation Regulation for Registration of Medicinal Products Regulations on Human Trials Regulation on Good Clinical Practice (GCP) Regulation on Good Manufacture Practice (GMP) Regulation of the Lot Release Procedures for Biologics
Guidance Guidance for Registration of Vaccines Guidance for Registration of Pandemic Influenza Vaccines Guidance for Strain Change Supplements of Seasonal Flu Vaccines
International Guidance
ICH/EMA/FDA/WHO guidance which are issued in an issue-specific manner are taken into reference E.g., viral safety, expression construct, specification, cell substrate, individual vaccine
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Application Process
Submission Administrative part and
Technical part
Registry on Taiwan
Clinical Trials Network
Applicants (Sponsor、CRO、Hospital)
Consultation
<IND>
User Fee 30,000 NTD
Submission Administrative part and
Technical part
Applicants (Sponsor)
Consultation
User Fee 800,000 NTD
<NDA> TFDA
Registration
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Vaccine Product Approval Process
Phase I safety and
immunogenicity studies performed in a small number
of closely monitored
subjects
Phase II
dose-ranging studies and may enroll hundreds
of subjects.
Phase III
typically enroll thousands of
individuals and provide the critical documentation of effectiveness and
important additional safety data required
for licensing
NDA submission
and Evaluation
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Evaluation Process
Application submitted to TFDA
Integrated Medicinal Products Review Office (iMPRO)
Administrative part
Technical part
CMC Pharm/Tox PK/PD Clinical Statistics
Assessment Report
if necessary
Final Decision made by TFDA
Documentation Evaluation
Asking for suggestion
Providing opinion
Advisory Committee
IND: 30 days NDA: 360 days
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Abbreviated Review:NCE + US FDA, EMA, MHLW approved (2 in 3) AA: Accelerated approval (AA): Surrogate endpoint CT accepted
NDA review track
Regular
Standard Review
(360 days)
Abbreviated Review
(180 days)
Unmet medical need
AA applicable
Priority Review
(240 days)
Priority + Abbreviated
* *
Expedited Programs for NDA
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Common Technical Document Format
When submitting NDA, ICH Common Technical Document (CTD) Format should be used.
1 Regulatory administrative information
2 Overall summary (Quality, Non-clinical, Clinical)
3 Quality
4 Non-clinical study
reports
Add Your Text
5 Clinical study reports
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Technical Document
Quality Non-Clinical Clinical Source Controls (Reagents, Excipients)
Virus or Cell Banks (Size, Passage number)
Characterization Manufacturing
Process Control Safety issues • Sterility • Purity/Impurities • Identity Efficacy issues • Potency • Stability
Batch analysis Stability
Pharmacology (relevant animal models of disease; injury if possible)
Toxicology (relevant healthy animal species)
Current clinical experience
Study design (administration procedure, proposed dose levels, regimen, escalating)
Selection of patients (inclusion/exclusion criteria)
Safety evaluations Efficacy evaluations Statistical considerations
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Manufacture
GMP
• PIC/S Participating Authority since 2013
• All manufacturers shall fully comply with the current version of PIC/S GMP Guide since 2015
• Current status: (up to 2th October 2017)
– Domestic pharmaceutical drug product
manufacturers: 137
– Companies not comply with PIC/S GMP
• shall cease manufacturing and be delisted.
1982~
cGMP (validation)
1995~ 2007.12~
PIC/S GMP
PIC/S Participating Authority
2013~
All PIC/S GMP compliance
2015~
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Testing
Manufacture of Vaccine
Lot release Testing by Sponsor
Lot Release Testing by
TFDA
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Transport
Manufacture
• GMP
Storage, Transportation
• GDP
• GDP
Quality Assurance
Good Manufacturing Practices
Hospital, Clinics to Patients
Good Distribution Practices
Good Dispensing Practices
Ensuring the quality and package integrity during the manufacturing, storage and transportation.
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Implementation Schedule of GDP
NEW
ALL
From July 1, 2016, all
new manufacturer,
logistics company and license applicator shall comply
By January 1, 2019, the existed manufacturers, logistics companies and license holder shall comply
Announcement of “ Guide to Good Distribution Practice for Medicinal Products” 【2015-7-16】
Inspection: with GMP, or application before 2017-12-31, whichever comes first
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Traceability
Government:
Announcing drug items to be traced and reported
Establishing e-reporting system
Stakeholders:
Establishing traceability system and e-reporting
§ 6-1 Enhance Drug Supply Chain Integrity
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Pharmacovigilance
Safety Monitoring e.g. reporting system, PSUR
Refinement and Evaluation
Risk Management e.g. label change, restrict use, withdrawal
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Pharmacovigilance of Influenza vaccine
Monitoring period: October to March(next year)
Period 2014-2015 2015-2016 2016-2017
Reporting number 66 90 142
Vaccination number
(unit: 10,000)
289.7 307.5 606.3
Ratio (reporting
number/100,000 vaccination)
2.3 2.93 2.34
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Outline
Organization and Responsibility of TFDA
Life Cycle Management of Vaccine
Regulations for Pandemic Influenza Vaccine
Prospects
Consultation System
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Global Example of Emerging and Re-emerging Infection Disease
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Mockup Vaccine
A mock-up vaccine is a type of flu vaccine that is developed well before a
pandemic has started. Because the strain of flu virus that will cause a
future pandemic is not known, pharmaceutical companies cannot start to
prepare a vaccine containing the correct flu virus until a pandemic has
started. To get around this problem, the mock-up procedure (also known
as the ‘core dossier’ procedure) allows vaccine manufacturers to gain an
authorisation for a prototype pandemic vaccine in advance of a pandemic.
This approach is unique to pandemic vaccines.
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Fast Track Approval
Core pandemic dossier (follow the standard procedure of
NDA submission)
Pandemic Strain Variation
TFDA/CDE
Review and Evaluation
Process
Decision
Pandemic Period
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Case Study: H1N1 (2009) Vaccine
The 2009 H1N1 flu virus (referred to as swine flu) is a new influenza virus strain that is causing illness in people. This new virus strain is spreading from person-to-person worldwide, probably in much the same way that regular seasonal influenza viruses spread.
Approved as strain change supplements to the seasonal flu vaccine, that consistent with licensure of annual strain changes to seasonal vaccines.
Manufacturers utilized the same egg-based manufacturing process as for their licensed seasonal vaccines
Vaccines contained the same quantity of antigen as a single strain of seasonal vaccine.
Anti-HA antibody levels (measured by the hemagglutination inhibition assay) as a marker for efficacy.
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Challenges for pandemic vaccine (H7N9) development
Antigen dose, number of doses
Timing of availability of clinical data
Pathways and regulatory process to speed vaccine approval
Facilitating vaccine manufacturing and availability
Seed virus development
Potency testing method and reagents
Vaccination program
Assuring safety and public confidence
Regulatory
Clinical Trial
Manufacturing
Public Health
Case Study: H7N9 Vaccine
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Outline
Organization and Responsibility of TFDA
Life Cycle Management of Vaccine
Regulation of Pandemic Vaccine
Prospects
Consultation System
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Consultation System
Consultation System
Consultation by Request
Active Consultation
Industrial Communication
Platform
Domestic Innovative Consultation
(Early Harvest Lists)
National Research Program for Biopharmaceuticals
(NRPB)
Online Information
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To facilitate medicinal products development and marketing approval
What is needed at consultation?
Well-developed & -controlled manufacturing information
Preclinical studies to show safety and effect of products
Provide evidence to support human dosing and scientific rationale
Meeting types: Kick-off meeting Sponsor meeting Pre-filing meeting
Domestic Innovative Consultation
KO P P P S S S
Pre-Clinical
Phase I Phase II Phase III NDA Review
Rolling Review
Regular path
Consultation P
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Case Study: EV71 Vaccine
1. Regulatory Agent established “EV71 Vaccine Task Force Working Group”
to provide the regulatory consultation services to the EV71 vaccine
researchers.
2. The Issue-Oriented Advisory Committee Meeting (IOACM) has been held
with experts to solve special issue.
3. TFDA/CDE provided “early and frequent consultation”, “rolling review
mechanism” and “priority review” to build up a fast track for EV71 vaccine
IND review.
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Outline
Organization and Responsibility of TFDA
Lifecycle Management of Vaccine
Regulations for Pandemic Vaccine
Prospects
Consultation System
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Regulatory Cooperation
Step in to Taiwan Today Step out to the World Tomorrow
To participate in the international activities to acquire update information
To establish a sustainable platform for promoting regulatory convergence, capacity and cooperation in areas of medical products
To establish personnel exchange mechanism with regulatory agencies for regulatory harmonization or convergence
•Collaboration with Taiwan CDC on the vaccine safety data, vaccine adverse event reporting system
•Intense oversight of the manufacturing of vaccine in the post- marketing to ensure the safety product
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Triple-Win Situation
Consumer Protection
Industry Competences Enhancement
Government Smart
Administration
Win-Win-Win
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The products of vaccine have unique regulatory considerations
from other medical products. (highly regulated biologics, high risks of starting
materials, fully aseptic process, for healthy individual use, children or elders)
The manufacturing sites of vaccine are needed to complied with
PIC/S GMP, and post-marketing safety evaluation system of
vaccine is important.
Consultation system help the researchers to solve the regulatory
problems and facilitate the new vaccine development.
Regulatory harmonization and convergence reduce the hurdle of
application of new vaccine products and facilitate the marketing
time.
Summary
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Thank You for Your Attention