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Retrieved from [link] Japan PharmaceuticalManufacturers Association. Pharmaceutical Regulations in Japan 2020. Retrieved from [link] Pharmaceuticals and Medical Devices Agency. Japanese Pharmaceutical and Regulatory Environment. Freyr Solutions. 11 Must-know FAQs about the Drug Approval Process in Japan.
The results generated in the study will be combined with data from Tohoku’s Medical Megabank Project (TMM), a wide-ranging national project that is tracking the health of the Japanese population, originally set up in response to the 2011 earthquake and tsunami.
Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation.
Consequently, the implementation of track and trace systems for pharmaceuticals is becoming more important as countries make it a legal requirement. For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011.
FDA – Process Validation Guidelines (published in January 2011) are crucial for maintaining the quality management system. assay result) meeting its predetermined specifications and quality attributes (i.e., accuracy, precision, etc.) – Routine recording of environmental parameters (e.g., temperature, air pressure, etc.)
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