Japanese regulations and JSQA update. Tadahiro Yoshiyama International Affairs Committee Director of GLP Division November 11, 2016

Transcription

1 Japanese regulations and JSQA update Tadahiro Yoshiyama International Affairs Committee Director of GLP Division November 11, 2016

2 Contents Japanese regulatory updates of the GxP systems Recent activities in JSQA Expectations of new collaborations between RQA and JSQA International Affairs Committee / JSQA 11/11/2016 2

3 Japanese regulatory updates of the GxP systems International Affairs Committee / JSQA 11/11/2016 3

4 Summary Over the past year, a partial revision and expansion of the evaluation scope occurred in the Japanese GxP systems The inspection methods and perspectives of the Japanese regulatory authority may be changed International Affairs Committee / JSQA 11/11/2016 4

5 Expansion of the GLP evaluation scope 1. Coming into effect in GLP ordinance for cellular and tissue based products Ministerial Ordinance on Good Laboratory Practice for Non Clinical Safety Studies of Cellular and Tissue Based Products (Ordinance of the Ministry of Health and Welfare No. 88 of July 30, 2014) 2. Start of the facility inspection by PMDA and inspection of 8 facilities has already been carried out JSQA started collection and analysis of the information about the inspection by PMDA in GLP subcommittee 5 International Affairs Committee / JSQA 11/11/2016

6 Coming into effect in New OECD Advisory Document on GLP computerized system OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING Number 17 Impact in the CSV activity in Japan Responsibility of the Facility Management newly recognized Scope Validation activity of the appropriate frequency according to a risk assessment results Personnel Life Cycle Importance of the participation of Study director, IT person and system vendor Periodic Review Securing of quality of Electric Record& Signature System Inventory Validation strategy based on potential risks to data integrity Risk Assessment Up-to-date listing of all GLP-relevant systems International Affairs Committee / JSQA 6

7 Japanese Compassionate Use (J-CU) has begun at last Japanese Good Clinical Practice (J-GCP) was partially revised this year, because the inclusion of J-CU. the partial revision of J-GCP for Drugs MHLW Ministerial Ordinance No.9 became effective from Jan 22, the partial revision of J-GCP for Medical Devices MHLW Ministerial Ordinance No.128 became effective from Jul 21, the partial revision of J-GCP for Regenerative Medicines MHLW Ministerial Ordinance No.129 became effective from Jul 21, J-CU applications 3 protocols were published. (As of 30 Sep., 2016) International Affairs Committee / JSQA 11/11/2016 7

8 Revision of the recent GVP-related law Revision of the Pharmaceutical Affairs Law (November 27, 2013) GVP-related laws were revised(july 30, 2014) Summery of Revision GVP ordinance Cellular and tissue based products were increased as an object of post-marketing safety management operations Pharmaceutical Affairs Law Enforcement Regulation About the entrustment of post-marketing safety management operations, Re-entrustment was accepted, under the constant condition 8 International Affairs Committee / JSQA 11/11/2016

9 Recent GVP In-compliances In one company, advance reaction was not reported within the period by system failure. Medicinal Product : 5475 cases (57 ingredients) Investigational Products: 154 cases (28 ingredients) Correspondence of the MHLW To One company which violated Business Suspension Order :15 days Business Improvement Order : Twice To Representatives of first-class Pharmaceutical marketing authorization holders (271 Companies) Requested to do Voluntary Self-Inspection about the inhouse GVP systems Result In 20 companies, the defects of the procedure were found out In 6 companies, Advance reaction information unreported (88 cases in total 133 examples)

10 Recent activities in JSQA Making of medium and long term administration policies, covering the next 5 years International Affairs Committee / JSQA 11/11/

11 Making of medium and long term administration policies and schedules JSQA set the policies and plans for our activities in line with the change in environment Structure of Members (As of 31 Aug., 2016) 1366 members from 426 companies GQP/GVP/GPSP Division 15% GLP Division 37% GCP Division 48% GLP Division: 496 members from 155 companies GCP Division: 662 members from 187 companies GQP/GVP/GPSP Division: 208 members from 84 companies International Affairs Committee / JSQA 11/11/

12 Making of medium and long term administration policies and schedules Policies and schedules aim at getting the following results in five years Announcement of the outcome of the selected study Publication of the activity result by methods such as a presentation at the meeting or the article contribution. Collection of outside evaluations about activities and referring them to the next problem setting meeting. Completion of the educational training system & establishment of the QA authorization Establishment of the QA authorization in each GxP system. International Affairs Committee / JSQA 11/11/

13 Making of medium and long term administration policies and schedules Policies and schedules aim at getting the following results in five years The strengthening of the liaison between external/internal related associations and regulatory authorities Collaboration with external/internal related associates and regulatory authorities. Further cooperation between RQA, SQA and JSQA, about 5 th and 6 th GQAC. Arrangement of operations and systems, leading to activation Increase the number of members engaged in the GQP/GMP/ GDP, Medical device or QMS. International Affairs Committee / JSQA 11/11/

14 Expectations of new collaborations between RQA and JSQA International Affairs Committee / JSQA 11/11/

15 Effective use of collaborations JSQA is expecting further collaborations with RQA, on various topics The making of deliverables through collaborations The employment of RQA training materials for JSQA personnel The holding of periodical meetings about an discussion items International Affairs Committee / JSQA 11/11/

16 Autumn Scenes in Japan JSQA will support the 5th GQAC.So, through cooperation and information sharing, let's make this event a success. 11/11/20 International Affairs Committee / JSQA 16 16

17 Effective use of collaborations The deliverables which come from the material of the collaboration. Activity Summary of 12th Term( ) - GLP Division - GCP Division - GQP/GVP/GPSP Division - Common Special Project 1, 2 Activity Summary of 11th Term( ) - GLP Division - GCP Division - Common Special Project 1, /11/ International Affairs Committee / JSQA

18 Thank you ありがとうございました International Affairs Committee / JSQA 11/11/