Sumitomo Dainippon Pharma Annual Report 2017

PartnercompaniesCollection of safety information (clinical studies, post-marketing, etc.)Medical professionals(physicians, pharmacists, etc.)Regulatory authorities in each country(PMDA, FDA, EMA, etc.)Medical institutionsperforming clinical studiesProvision of informationReportingReportingProvision of informationSending of informationSumitomo Dainippon Pharma Group(Sumitomo Dainippon Pharma, Sunovion, etc.)Integrated management using the safety information databasePMDA : Pharmaceuticals and Medical Devices Agency FDA : U.S. Food and Drug AdministrationEMA : European Medicines AgencyCorporate RegulatoryCompliance & Quality AssuranceFrom development topost-marketing services,assuring the global quality ofproducts and information.The Sumitomo Dainippon Pharma Group is developing new drugs in Japan, the U.S., Europe, China, and other countries, while also receiving approval from regulatory authorities in each country and delivering products to patients and healthcare professionals around the world. In order to provide products that patients and healthcare professionals can use with a sense of safety and reassurance, the Group has established global policies for quality and safety management. Under a Global Regulatory Compliance System that unites us with our subsidiaries outside Japan, we are collectively striving to provide high quality products.We provide guidance and perform audits for all manufacturing and packaging subcontractors in each country, since it is necessary to assure quality across the entire supply chain for pharmaceutical products. This approach to quality assurance activities, from development to post-marketing services, is implemented under a global framework.Quality Assurance System for making people worldwide feel reassured and safeInside Japan, Sumitomo Dainippon Pharma’s Quality Information System is designed to ensure prompt responses to inquiries regarding product quality from medical institutions. We use this system under the Good Quality Practice (GQP)*1 ordinance.When an inquiry from a medical institution is submitted to our Quality Information System, the plant at which the product was manufactured takes immediate steps, checking retained samples from the same lot, and verifying manufacturing records to confirm the quality of the product in question. The underlying cause of the incident is also investigated, and when necessary, the plant develops and implements preventive measures.Members of departments such as Safety Management, Sales & Marketing, Manufacturing, and Quality Assurance can access the system so that they can promptly evaluate safety and provide replacements for the products if needed. Our Quality Information System also has a search function which enables us to analyze quality issue trends per each product type and time period to prevent similar problems in the future. In addition, our MRs (medical representatives) carry tablet terminals that have answers to many expected inquires, which facilitates a speedier response to inquiries.Prompt Responses to Inquiries Using a UniqueQuality Information SystemAdverse reactions that were unpredictable during the development stage can appear once pharmaceuticals have started to be used by a large number of patients under various conditions after manufacturing and marketing approval. Therefore, it is important to promote the proper use of pharmaceuticals by collecting and evaluating a wide range of information on safety and efficacy and assessing their benefit and risk in the post-marketing period. It is also important to Promoting Global Safety Management and ProperUsage of Products*1 Good Quality Practice: A standard for managing the quality of pharmaceuticals, quasi-pharmaceuticals, cosmetics and medical devices (manufacturing and marketing quality assurance standard).Flowcharts : Safety Information31Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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