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• Collaboration plan to accelerate review of MDs
• Revision of Pharmaceutical Affairs Law
(PAL); Implementation of PMD Act.
2
This plan from FY 2014 to FY 2018 aims to shorten and standardize the review periods of MD approval in cooperation with the Japanese regulatory authorities and industries by;
1. Taking measures to improve the quality of review process Training for applicants, Efficient consultation service, Standardization of review process
2. Setting standard review periods 80th percentile value out of application cohorts should satisfy each targeted overall review
period from MD application to its approval.
3. Managing progress of this plan Regulatory authorities and industries will check its progress regularly and take necessary
action(s) so that it works well.
Collaboration plan to accelerate review of MDs (issued on 31 March 2014)
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80th percentile value out of application cohorts will satisfy the following targeted overall review period from MD application to its approval by end of FY2018;
1. Brand new medical device • Normal review process: 12 months • Priority review process: 9 months
2. Improved medical device • With clinical trial data: 9 months • Without clinical trial data: 7 months
3. “Me-too” medical device • New approval application: 5 months • Partial change approval application: 4 month
Increase of reviewers with higher application fees will be needed.
Standard review periods in the collaboration plan
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Key Achievements • Shortening review periods. • Increasing the number of reviewers as well as enriching their training. • Clarifying review standards and enhancing consultation service. • Enhancing information disclosure. • Accelerating certification of class II MD by registered certification body. • Closely communicating between the regulatory authorities and
industries. Further Challenges • Improving the quality of review process involved by both reviewers and
applicants. • Shortening review periods. • Promoting standardization of review periods.
(Ref.) Key achievements and further challenges of Action Program from FY 2009 to FY 2013
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This program aimed to accelerate review of MD, based on efforts by the Japanese regulatory authorities and industries, by;
1. Increasing reviewers and enriching their training
2. Introducing a 3-track review system
3. Clarifying review standards
4. Taking other measures such as - Promotion of information disclosure - Progress management with regular meeting with stakeholders
(Ref.) Action program to accelerate review of MDs (from FY 2009 to FY 2013)
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This plan from FY 2014 to FY 2018 aims to shorten and standardize the review periods of IVD approval in cooperation with the Japanese regulatory authorities and industries by;
1. Taking measures to improve the quality of review process Training for applicants, Efficient consultation service, Standardization of review process
2. Setting standard review periods 80th percentile value out of application cohorts should satisfy each targeted overall review
period from IVD application to its approval. (13 months for IVD with opinions from external experts and 7 months for normal IVD)
3. Increase of reviewers 4. Managing progress of this plan Regulatory authorities and industries will check its progress regularly and take necessary
action(s) so that it works well. 7
Collaboration plan to accelerate review of IVDs (issued on 31 March 2014)
Topics
• Collaboration plan to accelerate review of MDs
• Revision of Pharmaceutical Affairs Law
(PAL); Implementation of PMD Act.
8
For implementation of PMD Act: • Authority and responsibility of Medical
Device Evaluation Division in MHLW have been strengthened since July 2014.
• Relevant cabinet and ministerial ordinances as well as notifications were issued in July and August 2014.
• The amendment law is to be enforced on 25 November 2014.
• More details will be notified subsequently. 9
(Ref.) PAL revision related information • Revision of Pharmaceutical Affairs Law (PAL)
was adopted by the Diet, and announced on 27 November 2013.
• Medical Device Development Promotion Act was announced on 27 June 2014.
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(Ref.) Summary of PAL revision • Points of the amendment are to;
1. Strengthen safety measures regarding drugs and medical devices 2. Revise medical device regulations based on its characteristics 3. Introduce Regenerative and Cellular Therapy Products (RCTP) &
Gene Therapy Products (GTP) regulations based on their characteristics
• Name of PAL will be changed to “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (, called “PMD Act”).
• The chapter for “Medical Device” will be prepared. 11
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Statistics
13
1 1 2 3 2 7 13 13 16 17
23 32 36 35
10 8 10
14 22
29
31 33 37
2 2
5
7
8
8
10 12
14
1 1
2
2
1
1
3 2
2
2 5
5
7
7
10
11
14 14
22 29
35
47 56
73
90 99
104
0
20
40
60
80
100
Number
Medicine/Dental
Animal Medicine
Science/Agriculture
Pharmacy
Engineering
Number of reviewers – increasing
14
15
Class FY 2009 FY 2010 FY 2011 FY 2012 FY 2013 I 1 - - - -
II 1,123 554 196 143 131
III 616 756 671 847 830
IV 295 324 360 545 386
Total 2,035 1,634 1,227 1,535 1,347
Certification 2,313 2,158 2,393 2,442 2,200
Number of certifications by registered certification bodies
Number of MD approvals – stable
FY 2006 2007 2008 2009 2010 2011 2012 2013 Goal
(months) － － － － 16 16 15 13
Performance (months)
－ 14.2 15.7 28.8 13.9 15.1 4.3 9.3
# － 1 4 4 3 3 6 5
Priority items
Normal items
FY 2006 2007 2008 2009 2010 2011 2012 2013 Goal
(months) － － － － 21 21 20 17
Performance (months)
10.3 15.7 15.1 14.4 11.0 16.5 9.7 12.7
# 5 14 19 12 33 15 27 41
Number and review time of brand new MDs – improving
16
3 3 6 5 14
16 16 15
13
10 13.9
15.1
4.3
9.3 9
0
5
10
15
20
0
5
10
15
20
FY2009 FY2010 FY2011 FY2012 FY2013
# of approvalTargeted periodResult of period
# of approval
Review period
(months)
* Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median value of approval cohort. * Source: PMDA Annual Report (FY 2013)
Brand new MD in priority process – targeted periods were satisfied
17
33 15 27 41 80
21 21 20
17
14
11
16.5
9.7
12.7
6.3
0
20
40
60
80
100
0
5
10
15
20
25
FY2009 FY2010 FY2011 FY2012 FY2013
# of approvalTargeted periodResult of period
# of approval
* Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median value of approval cohort. * Source: PMDA Annual Report (FY 2013)
Review period
(months)
Brand new MD in normal process – targeted periods were satisfied
18
30 40 55 44 63
16 16
14
12
10
17.2
15.5 13.9
17.3
11.6
0
20
40
60
80
100
0
5
10
15
20
FY2009 FY2010 FY2011 FY2012 FY2013
# of approvalTargeted periodResult of period
# of approval
Review period
(months)
* Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median value of approval cohort. * Source: PMDA Annual Report (FY 2013)
Improved MD with clinical data – some targeted periods were not satisfied due to review of many earlier applications
19
158 182 218 229 231
11 11 10
9
6
13.2 14.5 13.3
9.7
7.5
100
150
200
250
300
0
5
10
15
20
FY2009 FY2010 FY2011 FY2012 FY2013
# of approvalTargeted periodResult of period
# of approval
* Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median value of approval cohort. * Source: PMDA Annual Report (FY 2013)
Review period
(months)
Improved MD without clinical data – Any targeted periods were not satisfied due to review of many earlier applications
20
1797 1391 907 1216 958
8
6 5
4 4
12.9
11
5 4 3.9
0
500
1000
1500
2000
0
4
8
12
16
FY2009 FY2010 FY2011 FY2012 FY2013
# of approvalTargeted periodResult of period
# of approval
* Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median value of approval cohort. * Source: PMDA Annual Report (FY 2013)
Review period
(months)
“Me-too” MD – targeted periods were not satisfied since FY 2011
21
