Transcript S6-2_Tetsuomi Takano_Future Perspective on MRCT in East Asia

Future Perspective on MultiRegional Clinical Trial (MRCT)
in East Asia from A Viewpoint
of the Japanese Industry
Tetsuomi Takano (高野 哲臣)
Japan
Vice-Chair, Asia Committee, JPMA
Senior Director, Astellas Pharma Inc.
Disclaimer
The views and opinions expressed in the following
PowerPoint slides are those of the individual
presenter and should not be attributed to Astellas
Pharma Inc. and/or Japan Pharmaceutical
Manufacturers Association (JPMA), those
executives, auditors, employees, committees,
member companies or affiliates.
Tetsuomi Takano, Astellas Pharma Inc.
2
Contents
1. Histories of Multi-Regional Clinical Trial
(MRCT) globally and in Japan
2. Future Perspective on MRCT globally and
in East Asia
3. Current Status and Future Perspective on
MRCT in China
4. Summary
Tetsuomi Takano, Astellas Pharma Inc.
3
Ethnic Factors in the Acceptability of Foreign Clinical Data
(ICH E5 (R1), 05/Feb/1998)
Appendix A: Classification of intrinsic and extrinsic ethnic factors
INTRINSIC
EXTRINSIC
Physiological and pathological
conditions
Age (children-elderly)
Genetic
Gender
Height
Environmental
Climate
Sunlight
Pollution
Body weight
Liver
Kidney
Cardiovascular functions
ADME
Receptor sensitivity
Culture
Socioeconomic status
Educational status
Language
Medical practice
Disease definition/Diagnostic
Therapeutic approach
Drug compliance
Smoking
Alcohol
Race
Genetic polymorphism of the
drug metabolism
Food habit
Stress
Genetic diseases
Diseases
Regulatory practice/GCP
Methodology/Endpoints
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
4
Histories of ICH-GCP Implementation, Clinical Trial
Notification, and Clinical Trial Consultation in Japan
FY1997
J-GCP (revised)
[ICH-GCP concept]
Clinical Trial
Notification (revised)
Clinical Trial
Consultation
FY2003 FY2004
ICH-GCP “E6 (R1)” was globally introduced in 1996.
Handled by
Handled by
Pharmaceuticals and Medical
Devices Evaluation Center
(PMDEC)
Pharmaceuticals and
Medical Devices Agency
(PMDA)
Handled by
Handled by
Organization for
Pharmaceutical Safety and
Research (OPSR or “KIKO”)
Pharmaceuticals and
Medical Devices Agency
(PMDA)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
5
Clinical Development Plan for Chemical & Biological
Drugs in Japan (日本)
A. Fully Separated P1, 2 & 3
(Currently Feasible?)
Global
JP
Phase 1
Phase 2
Phase 3
Phase 1
Phase 2
Phase 3
D. Conducting Local PK &
Joining in Global P2 & 3
Global
PK
Global
JP
Phase 1
PK
Phase 3
Phase 2
Phase 2
C. Conducting Local PK &
Joining in Global P3
Global
Phase 1
Phase 2
JP
B. Conducting Local PK & P2
(Bridging Strategy)
Phase 1
Phase 2
Phase 3
Phase 3
JP
PK
Tetsuomi Takano, Astellas Pharma Inc., Asian Regional Drug Development Summit (Shanghai, 08/Sep/2015)
6
How we devise a development strategy, create a clinical
development plan, develop a clinical study protocol, and
decide participating countries in MRCTs in Asia?
Regulatory (NDA)
Requirements
Clinical & Medical
Practices
IND/CTA Review
Period
MRCT Guidelines
(e.g. ICH-E17,
MHLW & CFDA)
Government
Policy Change
Government
Encouragement
(Patient Access)
Marketing
Strategy, etc.
Dennis Normile, Science Vol 326, Issue 5959, Page 1470
(11Dec2009) www.sciencemag.org
H. Hirosaki, APEC MRCT Tokyo WS, 01/Nov/2011
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
7
Basic Principles on Global Clinical Trials in Japan
Notified on
28/Sep/2007
Japanese: http://www.pmda.go.jp/operations/notice/2007/file/0928010.pdf
English: http://www.pmda.go.jp/operations/notice/2007/file/0928010-e.pdf
[ Key Messages ]
 Importance of Clinical Trial Consultations
 Japan’s earlier joining in global trials, Japanese PK study beforehand, obtaining consistency
between the entire and Japanese population results from a global trial, and Japan’s joining in
global trials for orphan diseases as well as requiring thousands of subjects for true endpoint
(e.g. survival rate) are recommended.
Tetsuomi Takano, Astellas Pharma Inc., 5th Int’l Biopharma Industry Dev Innovation Forum (Shanghai, 12-13/Apr/2012)
8
Japan: Basic Principles on Global Clinical Trials
(Reference Cases)
Released on
05/Sep/2012
Japanese & English: http://wwwhourei.mhlw.go.jp/hourei/doc/tsuchi/T120906I0010.pdf
Tetsuomi Takano, Astellas Pharma Inc., China Trials 5, Global Clinical Development Summit (Beijing, 07/Nov/2012)
9
Basic Principles for Conducting Phase I Trials in the
Japanese Population Prior to Global Clinical Trials
(27/Oct/2014)
English version
Japanese: http://www.pmda.go.jp/files/000157480.pdf
English: http://www.pmda.go.jp/files/000157777.pdf
Yoshiaki Uyama, PMDA, Japan Promoting Policy and Approval System of Innovative Drugs Symposium (Beijing, 28/May/2015)
10
Pharmaceuticals & Medical Devices Agency
Japan Promoting Policy and Approval System of Inn
ovative Drugs Symposium, Beijing, May28, 2015
Contents
1. Histories of Multi-Regional Clinical Trial
(MRCT) globally and in Japan
2. Future Perspective on MRCT globally and
in East Asia
3. Current Status and Future Perspective on
MRCT in China
4. Summary
Tetsuomi Takano, Astellas Pharma Inc.
11
ICH E17： General principle on planning/designing
Multi-Regional Clinical Trials
Description : This topic was endorsed by the ICH Steering Committee in June 2014.
• This new guidance is proposed to provide guidance on general principles on
planning/designing Multi-Regional Clinical Trial (MRCT).
• Drug development has been globalised and MRCT for regulatory submission has widely
been conducted in ICH regions and beyond. Regulatory agencies are currently facing some
challenges in evaluating data from MRCTs for drug approval and it was deemed necessary
to developed a harmonised international Guideline to promote conducting MRCT
appropriately, especially focusing on scientific issues in planning/designing MRCTs. This
new Guideline will complement the guidance on MRCTs provided in ICH E5(R1) Guideline
and facilitate MRCT data acceptance by multiple regulatory agencies.
Status : Step 3
• EC: Deadline for comments by 31 January 2017
• MHLW/PMDA: Deadline for comments by 30 September 2016
• FDA: Deadline for comments by 8 November 2016
• Health Canada: Deadline for comment by 27 October 2016
• Swissmedic: To be notified
Future Plans
• 4th F2F EWG Meeting (Nov/2016, Osaka): Revise the guideline based on comments
received on the public consultation
• 5th F2F EWG Meeting (2Q/2017): Step 4
(Source: ICH website)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
12
Quotations from draft ICH E17 Guideline (1 of 4)
[Step 2 version dated 6 May 2016]
Objectives of the Guideline, and Background
• With the increasing globalisation of drug development, it has become
important that data from multi-regional clinical trials (MRCTs) can be
accepted by regulatory authorities across regions and countries as the
primary source of evidence to support marketing approval of drugs
(medicinal products). (1.1)
• The purpose of this guideline is to describe general principles for the
planning and design of MRCTs with the aim of increasing the
acceptability of MRCTs in global regulatory submissions. (1.1)
• Data from MRCTs are often submitted to multiple regulatory authorities
without a previous harmonized regulatory view on the study plan. (1.2)
• There are currently no ICH guidelines that deal with the planning and
design of MRCTs, although the ICH E5 Guideline covers issues relating
to the bridging of results from one region to another. (1.2)
(Source: ICH website)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
13
Quotations from draft ICH E17 Guideline (2 of 4)
[Step 2 version dated 6 May 2016]
Pooled Subpopulation and Pooled Regions
• For purposes of sample size planning and evaluation of consistency of
treatment effects across geographic regions, some regions may be
pooled at the design stage, if subjects in those regions are thought to be
similar enough with respect to intrinsic and/or extrinsic factors relevant to
the disease area and/or drug under study. (1.4)
• In order to further evaluate consistency of treatment effects
consideration could also be given to pooling a subset of the subjects
from a particular region with similarly defined subsets from other regions
to form a pooled subpopulation whose members share one or more
intrinsic or extrinsic factors important for the drug development program.
(1.4)
• Both pooled subpopulations and pooled regions should be specified at
the study planning stage and be described in the study protocol. (1.4)
• Examples of pooled subpopulations include Hispanics living in North and
South America, or Caucasians living in Europe and North America.
Examples of pooled regions include East Asia, Europe, and North
(Source: ICH website)
America. (2.2.5)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
14
Quotations from draft ICH E17 Guideline (3 of 4)
[Step 2 version dated 6 May 2016]
Encouragement of Consultation Meetings
• In the planning and design of MRCTs, it is important to understand the
different regulatory requirements in the concerned regions. (1.4)
• Efficient communication among sponsors and regulatory authorities at a
global level can facilitate future development of drugs. These
discussions are encouraged at the planning stage of MRCTs. (1.4)
• Sponsors of MRCTs are encouraged to have scientific consultation
meetings with regulatory authorities. These interactions should take
place during the planning stage of MRCTs to discuss the regulatory
requirements for the overall development plan and the acceptability of
MRCT data to support marketing authorisations. (2.1.3)
• Conducting such consultation meetings early in the planning stage of
MRCTs will enable the comments received from regulatory authorities to
be taken into consideration. (2.1.3)
(Source: ICH website)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
15
Quotations from draft ICH E17 Guideline (4 of 4)
[Step 2 version dated 6 May 2016]
The Values of MRCTs in Drug Development
- Avoiding Unnecessary Duplication of Studies
- Simultaneous NDA/MAA Submissions in Different Regions
• MRCTs can facilitate simultaneous global drug development by reducing
the number of clinical trials that need to be conducted separately in each
region, thereby avoiding the ethical issue of unnecessary duplication of
studies. (2.1.1)
• Although MRCTs require more coordination during the planning stage
and possibly increase start-up time, their use can provide a pathway for
earlier access to new drugs worldwide. (2.1.1)
• The timing of clinical drug development across different regions can be
synchronised by the use of MRCTs, in comparison to local trials
conducted independently in each region. MRCTs may therefore
increase the possibility of submitting marketing authorisation applications
to multiple regulatory authorities in different regions simultaneously.
(2.1.1)
(Source: ICH website)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
16
Contents
1. Histories of Multi-Regional Clinical Trial
(MRCT) globally and in Japan
2. Future Perspective on MRCT globally and
in East Asia
3. Current Status and Future Perspective on
MRCT in China
4. Summary
Tetsuomi Takano, Astellas Pharma Inc.
17
Clinical Development Plan for Chemical Import Drugs
in China (中国) (Current DRR, SFDA 2007 No. 28)
A. Conducting Local PK & Joining in Global P3
(Chemical Category 3 for Import Drugs; NDA with CPP)
Global
Phase 1 Phase 2
Phase 3
CN
PK
Chemical Category 3 for Import Drugs
Local PK data + P3 ( 100 pairs)
cf. Chemical Category 1 for Import Drugs
P1 (20-30) + P2 (100) + P3 (300)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
18
Clinical Development Plan for Biological Import Drugs
in China (中国) (Current DRR, SFDA 2007 No. 28)
A. Conducting Local P1 &
Joining in Global P2 & 3
Global
B. Conducting Local P1 & 2
& Joining in Global P3
Global
Phase 1
Phase 1 Phase 2
Phase 3
Phase 2 Phase 3
CN
Phase 1
CN
Phase 1 Phase 2
Biological Treatment Category 1 & 7 for Import Drugs
P1 (20) + P2 (100) + P3 (300)
Biological Prophylaxis Category 1 & 6 for Import Drugs
P1 (20) + P2 (300) + P3 (500)
 China can join in MRCT for Import Drug which
is already approved or in P2 or P3 abroad
 China cannot join in MRCT for Prophylaxis
Vaccine which is not yet approved abroad
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
19
MRCT Descriptions on China’s Drug Registration Regulation (DRR)
(SFDA Order No. 28) (effective since 01/Oct/2007)
Article 44: A foreign applicant who wants to conduct an international multi–center
clinical study shall apply at SFDA in accordance with the following provisions:
1) The investigational drug used for an international multi–center clinical study shall be
one already registered in a foreign country or in phase II or phase III clinical trials.
An application for an international multi–center clinical study of new preventive
vaccine from a foreign applicant still not registered outside China shall not be
accepted by SFDA.
2) In approving an international multi–center clinical study in China, SFDA may request
the applicant to firstly conduct the Phase I clinical trials in China.
3) During a study conducted in China, the Applicant shall, in accordance with the
relevant regulations, report to SFDA any serious adverse events or unexpected
adverse events which occur in any countries.
4) Upon the completion of the study, the Applicant shall submit the complete clinical
study report to SFDA.
5) Data generated from an international multi–center clinical trial, if used for drug
registration in China, shall be in accordance with the relevant provision of this
Regulation, and the applicant shall submit the complete research information of the
study.
Tetsuomi Takano, Astellas Pharma Inc., Asian Regional Drug Development Summit (Shanghai, 08/Sep/2015)
20
China Clinical Development Plan of Chemical Import Drugs
(P3 MRCT Scenario) (Current DRR, SFDA 2007 No. 28)
1. Local Chinese PK study by healthy volunteers or patients followed
by P3 MRCT (sequential two studies)
Local PK
P3 MRCT
2. Local Chinese PK study by healthy volunteers or patients during
P3 MRCT (two studies in parallel)
Local PK
P3 MRCT
3. Local Chinese PK cohort by patients within P3 MRCT (one study)
P3 MRCT incl. local Chinese PK cohort
As local Chinese PK data for China NDA, single and multiple dosing
are basically requited.
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
21
China NDA Review Process of Chemical Import Drugs with MRCT Data
(officially endorsed in Jan. 2015)

3 submissions 3 approvals with speed-up review (transitional special
measures for 2nd-round submission before 23/Dec/2013)
MR CTA
Submission
MR CTA
Approval
13M
（RDPAC benchmark）

MRCT
CPP
LCT Waiver
Approval
36M
（RDPAC benchmark）
NDA
Submission
NDA
Approval
CPP
3 submissions 3 approvals without speed-up review (for 2nd-round
submission after 24/Dec/2013)
MR CTA
Submission
MR CTA
Approval
13M
（RDPAC benchmark）

LCT Waiver
Submission
LCT Waiver
Submission
MRCT
CPP
LCT Waiver
Approval
36M
（RDPAC benchmark）
NDA
Submission
NDA
Approval
CPP
Expected scenario after the implementation of the revised Drug Registration
Regulation around 2017 (3 submissions 3 approvals would be abolished.)
MR CTA
Submission
MR CTA
Approval
NDA
Submission
NDA
Approval
MRCT
(CPP)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
22
Introduction of IMCT/MRCT Guidance (Trail version) by CFDA
(Issued on 30/Jan/2015, implemented on 01/Mar/2015)
As per CFDA officers in a workshop:
 IMCT guideline is drafted based on current problems but will
mainly take into account the scientific system in the future. It has
international vision and foresight.
 Under existing law and regulation framework in China
 This guideline is applicable to the application, implementation and
management of IMCT in China sponsored by MNCs and local
pharma companies.
 Trial implementation period will be 1 year. It will be improved
further based on suggestions collected during the trial
implementation period and new development of ICH-E17.
 This guideline is used for both chemical drugs and biological
products.
 This guideline is not to resolve the issue of “3 submissions and 3
approvals.”
(Supported by RDPAC for English translation)
Tetsuomi Takano, Astellas Pharma Inc., Asian Regional Drug Development Summit (Shanghai, 08/Sep/2015)
23
Outline of the Opinions of the State Council on Reforming
the Evaluation and Approval System for Drugs and Medical
Devices (State Council Doc 2015 No.44, 18/Aug/2015)
and the CFDA Reform Plan
3-year reform plan initiated by China’s State Council to reform the evaluation and
approval system for drugs and medical devices since August 2015
Key Objectives
5
4
12
Safeguard
Measures
Major Tasks
2015
Key Objectives
•
•
•
•
•
Improve the quality of review and approval
Resolve the backlog of registration applications
Improve the quality of generic drugs
Encourage research and innovation
Increase review and approval transparency
Faster and more improved & transparent processes for
innovative drugs
2016
2017
2018
5 new registration categories for chemical drugs defined
Source:
Still updating; still partially under discussion and unclear;
need close observation and discussion
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
24
Some Key Changes on the CFDA Reform Plan
 New definitions of “New Drug” and “Generic Drug” were described in
the Sate Council Opinions on 18/Aug/2015 (2015 No.44).
 After that, new definitions and categories of “New Drug”, “Generic Drug”
and “Overseas Marketed Drug” for Chemical Drugs have been
implemented since 04/Mar/2016.
 Marketing Authorization Holder (MAH) pilot program for Chemical
Drugs, Biological Products, Traditional Chinese Medicines and Natural
Drugs has been started. Its implementation period is from 06/Jun/2016
till 04/Nov/2018. Pharmaceutical R&D institution or researcher in the
10-designated districts can become a MAH.
 MRCT-related descriptions in the State Council Opinions on
18/Aug/2015 (2015 No.44) (#7 of the Twelve Main Tasks):
 New drugs that have not been marketed overseas may conduct
simultaneous clinical trials in China.
 Domestic clinical trial institutions are encouraged to take part in
international multi-regional clinical trials (IMCTs) and any qualified
clinical trial data can be used in registration applications.
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
25
Work Program for the Reform of Chemical Drugs Registration
Category in China (Final, No.51 of 2016) (Mar. 4, 2016)
New registration category for chemical drugs
Registration
classification
Classification explanations
1
Innovative drugs not marketed in
and outside China
Conditions
Drug substances and their preparations containing new compounds with definite
structure and the pharmacological actions and possessing clinical value.
2.1 Drug substances and their preparations containing optical isomers, or
esterification, or saltification, or the alteration of the acid radicals, basic groups or
metal elements, or the formation of other non-covalent bond derivatives (complex,
chelate or clathrate) and possessing significant clinical advantages
2
Improved new drugs not
marketed in and outside China
2.2 Preparations of new dosage forms (including new administration systems), new
formulation and manufacturing processes and new routes of administration and
possessing significant clinical advantages.
2.3 New compound preparations containing known active ingredients and
possessing significant clinical advantages.
2.4 Preparations of new indications containing known active ingredients
3
Drugs generic to original drugs
marketed overseas yet not
marketed in China
Drug substances and their preparations possessing the same active ingredients,
dosage forms, strength, indications, routes of administration and dosage and method
of administration with original drugs.
4
Drugs generic to original drugs
marketed in China
Same as above
5
Applications of drugs marketed
overseas for marketing in China
5.1 Applications of original drugs marketed overseas (including drug substances and
their preparations) for marketing in China
5.2 Applications of non-original drugs marketed overseas (including drug
substances and their preparations) for marketing in China
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
26
Brief Comparison Table (Expected Pros and Cons)
between New Chemical Category 1 and 5.1 in China
Category
Definition
China NDA
Timing
Local Chinese
Clinical Data
Requirements
(Not yet
announced)
NDA Review
Period
(Not yet
announced)
Impact from the
Price
Commitment at
NDA Submission
1
Innovative
new drug not
marketed
inside and
outside
China
China NDA
submission before
the global first
NDA approval in
any country in the
world
(CPP is not
required.)
Local Chinese
clinical data for
Phase 1, 2 and 3
would be required.
Probably shorter
(accelerated)
timeline is
expected.
Probably least
(Not yet launched
in any of the
country of origin or
neighboring
country/region)
5.1
Drugs
marketed
outside
China
applying for
registration
in China
China NDA
submission after
an NDA approval
in foreign country
(CPP would be
required.)
Local Chinese
clinical data for PK
and Phase 3 would
be required.
Probably longer
timeline is
expected.
Would be affected
(Might be already
launched in the
country of origin
and/or some
neighboring
countries/regions)
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
27
Current Phase 3 MRCT Options in East Asia
- from A Viewpoint of the Japanese Industry -
1.
1st batch: JP → 2nd batch: CN, KR, TW
US, EU, JP
CN, KR, TW
2.
1st batch: JP, KR, TW → 2nd batch: CN
US, EU, JP, KR, TW
CN + other Asian countries
3.
1st batch: KR, TW → 2nd batch: JP, CN
China would move to
the 1st batch in the
near future due to the
implementation of the
CFDA Reform Plan.
US, EU, KR, TW
JP, CN
4.
1st batch: JP, CN, KR, TW together
US, EU, JP, CN, KR, TW
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
28
Draft Revision to Drug Registration Regulation (DRR)
(Released by CFDA for public comment on 25/Jul2016)
http://www.sda.gov.cn/WS01/CL0778/160300.html
MRCT/IMCT
 No description of “MRCT/IMCT” in the Draft Revision to DRR
 Issues on the 3-Submission-3-Approval would be resolved.
CFDA Accreditation of Clinical Study Sites
 No description of “Qualification of Clinical Study Sites” in the Draft Revision to
DRR (CFDA released on 2016.07.25)
Current DRR (177 articles in total)
(SFDA No.28, 2007.10.01-)
Article 34: After approval of a clinical study, the applicant shall select from the institutions
qualified for drug clinical trial to conduct the clinical study.
Draft Revision (147 articles in total)
(CFDA released on 2016.07.25)
Article 36: Each Applicant shall assess the institute and researchers administering the
clinical trial to ensure that the requirements of the clinical trial are satisfied and the human
subjects are duly protected.
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
29
Draft Revision to Drug Registration Regulation (DRR)
(Released by CFDA for public comment on 25/Jul2016)
http://www.sda.gov.cn/WS01/CL0778/160300.html
Permissibility of Foreign Clinical Data
 No description of “Permissibility of Foreign Clinical Data” in the Draft Revision
to DRR (CFDA released on 2016.07.25)
Draft Revision (CFDA released on 2016.07.25)
Article 30: An Applicant shall determine whether or not to submit a Clinical Trial Application
for its drug based on the novelty factor of the drug, available clinical trial data, and the
known and unknown risks. A clinical trial may be conducted in order, i.e., Phase I followed
by Phase II followed by Phase III, or feature cross or overlapping phases, or be modified
appropriately based on existing clinical trial data.
Number of Chinese Subjects in Clinical Trials
Draft Revision (CFDA released on 2016.07.25)
Article 67: Any Applicant who intends to use clinical trial data in its application for
marketing authorization in China shall submit all research materials relating to the clinical
trial. The number of Chinese subjects participating in the trial should be sufficient for
evaluating the safety and efficacy of the study drug among Chinese patients.
Tetsuomi Takano, Astellas Pharma Inc., 2016 KoNECT International Conference (Seoul, 03/Nov/2016)
30
Contents
1. Histories of Multi-Regional Clinical Trial
(MRCT) globally and in Japan
2. Future Perspective on MRCT globally and
in East Asia
3. Current Status and Future Perspective on
MRCT in China
4. Summary
Tetsuomi Takano, Astellas Pharma Inc.
31
Summary
 It is expected that the ICH E17 Guideline
will further accelerate both
- conducting MRCTs by pharmas and
- accepting MRCT data at NDA reviews
by regulatory agencies
in East Asia.
 After the implementation of the CFDA
Reform Plan, MRCT strategies/scenarios
in East Asia would be drastically changed.
Tetsuomi Takano, Astellas Pharma Inc.
32
감사합니다！
Win-Win Relationship Globally