New Direction of Japanese Regulations on MD/IVD - Japan Update -
Topics Collaboration plan to accelerate review of MDs Revision of Pharmaceutical Affairs Law (PAL); Implementation of PMD Act. 2
Collaboration plan to accelerate review of MDs (issued on 31 March 2014) 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 80 th 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. 3
Standard review periods in the collaboration plan 80 th 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: months Partial change approval application: 4 month Increase of reviewers with higher application fees will be needed. 4
(Ref.) Key achievements and further challenges of Action Program from FY 2009 to FY 2013 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.) Action program to accelerate review of MDs (from FY 2009 to FY 2013) 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 6
Collaboration plan to accelerate review of IVDs (issued on 31 March 2014) 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 80 th 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
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 2 November 2014. 9 More details will be notified subsequently.
(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.
(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
Number of reviewers increasing N u m b e r 0 80 60 40 20 0 22 21 7 29 3 2 1 2 8 13 13 47 7 2 7 14 6 7 1 8 22 23 16 17 90 14 14 2 11 2 14 73 3 12 1 8 33 37 31 29 32 36 3 1 1 2 3 2 4 99 Medicine/Dental Animal Medicine Science/Agricultur e Pharmacy Engineering 14
Number of MD approvals stable Class FY 2009 FY 20 FY 2011 FY 2012 FY 2013 I 1 - - - - II 1,123 4 196 143 131 III 616 76 671 847 830 IV 29 324 360 4 386 Total 2,03 1,634 1,227 1,3 1,347 Number of certifications by registered certification bodies Certification 2,313 2,18 2,393 2,442 2,200 1
Number and review time of brand new MDs improving Priority items FY 2006 2007 2008 2009 20 2011 2012 2013 Goal - - - - 16 16 1 13 (months) Performanc - 14.2 1.7 28.8 13.9 1.1 4.3 9.3 e (months) # - 1 4 4 3 3 6 Normal items FY 2006 2007 2008 2009 20 2011 2012 2013 Goal - - - - 21 21 20 17 (months) Performance.3 1.7 1.1 14.4 11.0 16. 9.7 12.7 (months) # 14 19 12 33 1 27 41 16
Brand new MD in priority process targeted periods were satisfied Review period (months) 20 1 16 16 13.9 1.1 1 13 # of approval Targeted period Result of period 9.3 9 20 1 # of approval 0 4.3 3 3 6 14 FY2009 FY20 FY2011 FY2012 FY2013 0 * Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median value of approval cohort. 17 * Source: PMDA Annual Report (FY 2013)
Brand new MD in normal process targeted periods were satisfied Review period (months) 2 20 1 21 21 11 16. 20 9.7 17 12.7 # of approval Targeted period Result of period 14 0 80 60 40 # of approval 6.3 20 0 33 1 27 41 80 FY2009 FY20 FY2011 FY2012 FY2013 0 * Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median value of approval cohort. 18 * Source: PMDA Annual Report (FY 2013)
Improved MD with clinical data some targeted periods were not satisfied due to review of many earlier applications Review period (months) 20 1 16 17.2 16 1. 13.9 14 17.3 12 # of approval Targeted period Result of period 11.6 0 80 60 40 # of approval 20 0 30 40 44 63 FY2009 FY20 FY2011 FY2012 FY2013 * Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median 19 value of approval cohort. * Source: PMDA Annual Report (FY 2013) 0
Improved MD without clinical data Any targeted periods were not satisfied due to review of many earlier applications Review period (months) 20 1 13.2 14. 11 11 13.3 9.7 9 # of approval Targeted period Result of period 7. 300 20 200 # of approval 6 10 0 18 182 218 229 231 FY2009 FY20 FY2011 FY2012 FY2013 * Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median 20 value of approval cohort. * Source: PMDA Annual Report (FY 2013) 0
Me-too MD targeted periods were not satisfied since FY 2011 16 # of approval Targeted period Result of period 2000 Review period (months) 12 8 4 12.9 8 11 6 4 4 4 3.9 100 00 00 # of approval 0 1797 1391 907 1216 98 FY2009 FY20 FY2011 FY2012 FY2013 0 * Targets are approved MDs for which application was made from FY2004 onward. review period (record) is median 21 value of approval cohort. * Source: PMDA Annual Report (FY 2013)