Overview of gqp and gvp
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This document discusses the responsibilities of Marketing Authorization Holders (MAHs) in Japan. It explains that MAHs must have a suitable quality control system called Good Quality Practice (GQP) and a suitable safety control system after manufacturing called Good Vigilance Practice (GVP). The GQP ensures quality assurance of medical devices, while the GVP standardizes the practice for safety control, such as collecting and evaluating safety information. The document also provides an overview of the GQP organization structure and reporting requirements under GVP.
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overview of Japan pharmaceutical regulatory authority - PMDA
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Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
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Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
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Abstract:
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• Understand your competitors’ business structures, strategies and prospects, and respond accordingly
• Make more informed business decisions with the help of insightful recommendations provided to succeed in the Indian medical devices market
Japan PMDA Medical Device Regulatory Approval Process
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
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Overview of gqp and gvp
- 1. Responsibility of Marketing Authorization Holders -Overview of GQP and GVP- Jan, 2014 Japan Regulatory Service
- 2. Contents Section 1. Requirements for MAH (Marketing Approval Holder) Section 2. What is GQP? Section 3. GQP Organization Structure Section 4. What is GVP? 2
- 3. Section 1. REQUIREMENTS FOR MAH 3
- 4. 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. 4
- 5. Section 2. WHAT IS GQP? 5
- 6. What is GQP? Market MAH Manufacturer Responsibility Retailer Product Management Permission for manufacturing a product Permission for guaranteeing the quality of a product Distribution, Rental Hospital GQP 6
- 7. 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 7
- 9. GQP Organization Structure MAH Management, direction Safety Control Manager General Manager of Manufacturing & Sales Report, Opinion Report, Opinion Cooperation Quality Control Manager Quality Control Dep. Safety Control Dep. Management, Quality check Market Management, direction Shipment Shipping instruction Manufacture 9
- 10. Section 4. WHAT IS GVP? 10
- 11. 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 11
- 12. What is GVP? Practice for GVP 1. Collection, classification, examination, and evaluation of safety information 2. Implementation of required measures 3. Self check 4. Educational training 5. Retention of records etc. 12
- 13. 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 13
- 14. 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 14