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