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Implementation of Bridging Study-Taiwan’s Experience. Meir-Chyun Tzou, Ph.D. Senior Officer, and Director of Section III, Bureau of Pharmaceutical Affairs Department of Health, The Executive Yuan Taipei, Taiwan, R.O.C. Outline. Health Organization and the Drug Regulatory Agency

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implementation of bridging study taiwan s experience
Implementation of Bridging Study-Taiwan’s Experience

Meir-Chyun Tzou, Ph.D.

Senior Officer, and Director of Section III,

Bureau of Pharmaceutical Affairs

Department of Health, The Executive Yuan

Taipei, Taiwan, R.O.C.

slide2

Outline

  • Health Organization and the Drug Regulatory Agency
  • Changing Environment of Clinical Trial in Taiwan
  • Regulatory Strategies for Implementation of Bridging Study
  • Current Status of Bridging Study Evaluation
  • APEC Joint Research Project on Bridging Study
slide3

Organization of the Department of Health,

the Executive Yuan, ROC

Bureau of Medical

Affairs

National Bureau of

Controlled Drugs

Bureau of

Pharmaceutical Affairs

Center for Disease Control

Secretary -

General

National Institute of

Preventive Medicine

Bureau of Food

Sanitation

National laboratories of

Food and Drugs

Bureau of Health

Promotion

Minister

National Quarantine

Service

Bureau of Health

Planning

Bureau of National

Health Insurence

Deputy/Vice

Minister

Office of Secretariat

Committee on Chinese

Medicine and Pharmacy

Office of Personnel

Affairs

NHI Supervisory

Committee

Office of Anticorruption

Specialist-General

Counselor

NHI Health Care Cost

Arbitration Committee

Office of Accounting

National Health

Research Institutes

Office of Statistics

Center for Drug Evaluation

regulations update for clinical trials
Regulations Update for Clinical Trials
  • Local clinical trial required for New Drug Registration since 1993
  • GCP guidelines implemented in 1997
  • GCP inspections for INDs and NDAs in 1997
  • Adverse Drug Reporting system in 1998
  • Guidances for clinical trials
impact on new drug development in taiwan
Impact on New Drug Development in Taiwan
  • Local clinical trials

-Improve new drug R & D in Taiwan.

-Facilitate development of

Biotech / Pharmaceutical Industry

global environment trends
Global Environment / Trends
  • International Harmonization for New Drug Registration : ICH
  • Trade Liberalization : WTO Accession
  • Biotech / Pharmaceutical Industry Promotion Plan
slide8

Consolidating Infrastructure for New Drug Clinical Trials in Taiwan

  • Improving quality and efficiency of review process for clinical trials
  • Promoting early phase clinical trials in Taiwan
  • Establishing Center for clinical study in Asia Pacific
  • Promoting Biotech-pharmaceutical Industry
slide9

Consolidating Infrastructure for New Drug Clinical Trials in Taiwan(1)

  • Improving quality and efficiency of review process for clinical trials
  • Reinforcement of GCP inspection
  • Guidances for clinical trials
  • Establishment of the Center for Drug Evaluation (CDE) in 1998

-full time review team

  • Parallel review process of IRBs and DOH
  • Establishment of Joint-IRB
  • Deregulation and streamlining the review process for clinical trials
slide10

Consultation

Applicant

Application Approval

C.D.E.

D.O.H.

(BPA)

Advice

Advisory Board

(Review Committee)

Consult

Center for Drug Evaluation

-expert review team for clinical trials and NDAs

DRF

BPA: Bureau of Pharmaceutical Affairs; CDE:Center for Drug Evaluation

DOH: Department of Health DRF: Drug Relief Foundation

parallel review process of irb jirb and doh
Parallel Review Process of IRB/JIRB and DOH

Conducting Clinical Trials

Approval

DOH (Regulator)

Approval

(IRB/J-IRB)

Hospital

Sponsor

CRO

slide13

Consolidating Infrastructure for New Drug Clinical Trials in Taiwan(2)

  • Promoting early phase clinical trials in Taiwan
    • Establishing general clinical research centers (GCRC) -improving the quality and performance of the CRC.
    • Establishing insurance and ADR reporting system for clinical trials
    • Establishing central lab. (clinical pathology unit)
  • -assuring the quality of clinical laboratory
    • Regulatory reform in local/clinical trial-bridging study
slide15

Regulatory Reform in Local/Clinical Trial –Bridging Study

  • Before-
  • An approved local clinical trial study report is required for the new drug application in Taiwan--July 7 Announcement in 1993.
  • Disadvantage: - A sample size of 40 as required would be difficult to demonstrate significant importance clinically or statistically- The study design of the local trial usually only repeated a study that has been done in the foreign countries but in a smaller sample size;The study has not been designed based on the medical situation in Taiwan
slide16

Regulatory Reform in Local/Clinical Trial –Bridging Study

  • After-
  • Bridging Study (Double Twelve Announcement, 2000) -Follow ICH E5 guidance
  • Advantage: - To avoid repeating unnecessary clinical study- Conducting, necessary, meaningful clinical study;based on differences of disease, ethnic differences etc, and the results of study, a dosage adjustment can be done for the locals
strategies for implementation of bridging study
Strategies for Implementation of Bridging Study
  • To follow closely the spirit of the ICH E5 guidance
  • To establish a sound and practical consultation and evaluation process
  • encourage sponsor to submit complete clinical data package for the evaluation of “bridging study” before new drug application
  • guidance and Q & A data base
  • self-evaluation checking list
  • consultation process
  • assessment scheme
slide18

Double Twelve Announcement

for Bridging Studies(Dec. 12, 2000)

  • Effective on January 1, 2001
  • One-year of transition period

-Local clinical trial bridging study

  • In accordance with ICH E5 guidance
  • Procedure of consultation and evaluation of bridging study
considerations for assessing the necessity of a bridging study 1of 4
Considerations for Assessing the Necessity of a Bridging Study ( 1of 4 )

Submit relevant documents

according to DOH

requirements and request

for waiving bridging studies

Does the drug meet DOH requirements for waiving

a bridging study and also the criteria for exempting

submission of information for ethnic consideration?(1)

YES

NO

Does the submitted preclinical and clinical

data package meet the regulatory requirements

(ICH E5 and DOH guidance on clinical trials)?(2)

Amendment

NO

YES

Is the medicine insensitive to both

intrinsic and extrinsic factors?Are the clinical differences in

efficacy and safety insignificant?

(See ICH E5 guidelines)

Does the package include clinical data

of Asian populations?(3)

NO

YES

YES

NO

slide20

Considerations for Assessing the Necessity of a Bridging Study ( 2 of 4 )

Does the package include clinical data

of Asian populations?(3)

Is the medicine insensitive to both

intrinsic and extrinsic factors?

Are the clinical differences in

efficacy and safety insignificant?

(See ICH E5 guidelines)

NO

YES

YES

Have any early phase trials or

global clinical trials that meet the

DOH requirements of bridging studies

been conducted in Taiwan?

YES

No bridging

study required(4)

NO

Based on the result of evaluation,

an appropriately designed

protocol of a bridging study

should be submitted to

DOH for approval(5)

NO

Is it reasonable to extrapolate from foreign

clinical data that the medicine is insensitive

to both intrinsic and extrinsic factors in Asians(3)

and that its clinical differences in efficacy and

safety are acceptable?(See ICH E5 guidelines)

YES

No bridging study required(4)

NO

slide21

Considerations for Assessing the Necessity of a Bridging Study ( 3 of 4 )

Is it reasonable to extrapolate from foreign

clinical data that the medicine is insensitive

to both intrinsic and extrinsic factors in Asians(3)

and that its clinical differences in efficacy and

safety are acceptable?(See ICH E5 guidelines)

YES

No bridging

study required(4)

NO

Is it reasonable to extrapolate from

foreign clinical data that the

concentration (dose)-response relationship

is similar between foreign and

Asian populations(3)?

YES

NO

Based on the result of evaluation,

an appropriately designed protocol

of a bridging study should be

submitted to DOH for approval.(5)

Is PK and/or PD data of Asian

populations(3) available for

estimating dosage or predicting efficacy?

NO

YES

slide22

Considerations for Assessing the Necessity of a Bridging Study ( 4 of 4 )

Based on the result of evaluation,

an appropriately designed protocol

of a bridging study should be

submitted to DOH for approval.(5)

Is PK and/or PD data of Asian

populations(3) available for estimating

dosage or predicting efficacy?

NO

YES

Using available data for

dose determination

  • (1) Apply for waiving bridging studies with reference to DOH announcements of waiving clinical trials. If the drug falls within the category that “requires submission of information proving no existence of ethnic differences”, it should be evaluated following this flowchart after the one year phase-in period.
  • (2) Under circumstances when evidence indicating potential intrinsic/extrinsic differences between Chinese and other Asian populations, a bridging study in Chinese population is a must.
  • (3) A bridging study will be required when there exists any safety concern.
  • (4) Under circumstances when evidence indicating potential intrinsic/extrinsic differences between Chinese and other Asian populations, a bridging study in Chinese population is a must.
  • (5) A bridging study can be a PK and/or PD study or any clinical study that can demonstrate the efficacy and safety of the medicine.
bridging study evaluation current status
Bridging Study Evaluation--Current Status--
  • Bridging study evaluation : 18 cases applied. (2001-present)
  • 8/11 (73%) waived (including 4 without complete Asian data).
  • Out of 3 not waived, 1 has safety concern, 2 did not have enough information.
impact of bridging study on clinical trials
Impact of Bridging Study on Clinical Trials
  • Promoting early phase / global clinical trials in Taiwan
  • Conducting necessary, meaningful clinical study based on scientific and medical circumstances (intrinsic/ extrinsic factors)
establish network of pharmaceutical regulatory science apec joint research project
Establish Network of Pharmaceutical Regulatory Science - APEC Joint Research Project -

Objectives:

  • To establish an APEC network of pharmaceutical regulatory science
  • To promote regulatory consensus through regional educational seminar, or APEC conference
  • To develop a sound and practical methodology for implementing bridging study in accordance with ICH E5 by APECmembers for the global new drug development
establish network of pharmaceutical regulatory science apec joint research project1
Establish Network of Pharmaceutical Regulatory Science - APEC Joint Research Project -

1999

2000

2001

At the 17th APEC ISTWG Meeting, all of the APEC economies have reached consensus on this project proposed and sponsored by Chinese Taipei and co-sponsored by Singapore, Philippines, Mexico, Malaysia, and Australia.

The 1st workshop was held in Taipei.

The 2001 symposium was held in Taipei.

slide28

The 2001 Symposium on APEC Network of

Pharmaceutical Regulatory Science- APEC Joint

Research Project on Bridging StudyConclusion(1)

1. Bridging justification should be

based on sound science and intrinsic /extrinsic factors,

not based on citizenship and nationality.

2. The regulatory agency should consider existing data and various factors (scientific and medical circumstances ) for drug approval.

3. Criteria for the similarity of efficacy,safety and quality between regions is needed.

slide29

The 2001 Symposium on APEC Network of

Pharmaceutical Regulatory Science- APEC Joint

Research Project on Bridging StudyConclusion(2)

4. Bridging: Multi-directional Input and output between ICH/ Non ICH region should be involved

5. ICH E5- Identifying the questions from APEC region, elaboration/supplement is needed.

6. Consolidate the networking of pharmaceutical regulatory science within APEC is obviously.