Responsibility of Marketing Authorization Holders
-Overview of GQP and GVP-
Jan, 2014
Japan Regulatory Service
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Contents
Section 1. Requirements for MAH (Marketing Approval Holder)
Section 2. What is GQP?
Section 3. GQP Organization Structure
Section 4. What is GVP?
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REQUIREMENTS FOR MAHSection 1.
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Requirements for MAH (Marketing Approval Holder)
1. An applicant does not correspond to disqualification matters.
2. The quality control system is suitable.= GQP
3. The safety control system after manufacturing and selling is suitable. = GVP
4. General manager for manufacturing and sales is installed.
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WHAT IS GQP?Section 2.
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What is GQP?
ManufacturerMAH Market
Hospital
Management
Product
Retailer
Distribution,Rental
Responsibility
Permission for manufacturing a product
Permission for guaranteeing the quality of a product
GQP
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What is GQP?
• Standard for Quality Control of medical devices
• GQP: Good Quality Practice• MHLW Ministerial Ordinance No. 136, 2004
Standard for MAH performing quality assurance of medical devices
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GQP ORGANIZATION STRUCTURE
Section 3.
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Manufacture
GQP Organization Structure
MAH General Manager of Manufacturing & Sales
Safety Control Manager
Quality Control Manager
Safety Control Dep. Quality Control Dep.
Market Shipment
Management, direction
Report, Opinion
Management, direction Report,
Opinion
Cooperation
Management, Quality check
Shipping instruction
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WHAT IS GVP?Section 4.
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What is GVP?
• Standard for Safety Control after manufacturing and selling a medical device
• GQP: Good Vigilance Practice• MHLW Ministerial Ordinance No. 135, 2004
Standard for MAH performing safety control of medical devices
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What is GVP?
Practice for GVP1. Collection, classification, examination, and
evaluation of safety information
2. Implementation of required measures
3. Self check
4. Educational training
5. Retention of records etc.
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What is GVP?
Report of the adverse event/defect based on the Pharmaceutical Affairs Law:
• Defect report, Infectious disease report
⇒ within 15 or 30 days • Measurement in abroad report
⇒ within 15 days• Research report
⇒ within 30 days
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Thank you for your time!
If you have any questions, we encourage you to contact us. Our contact information is on our website. There is a lot of information on the website, so I encourage you to take a look at: http://www.japan-rs.com. So, again, I encourage you to send us any questions or comments that you have on Japanese regulatory rule.
Thank you for your time.
Japan RS’s additional Learning Resources:
http://www.japan-rs.com/resources-e.shtml
Regulatory process in Japan:
http://www.japan-rs.com/2013-regulatory-process.shtml
Updated regulatory information for Medical Device:
http://www.japan-rs.com