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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Retrieved from [link] Japan Pharmaceutical Manufacturers 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.

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Takeda, Daiichi-backed wearable study planned in Japan

pharmaphorum

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.

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

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.

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Tracking the Drug Trail

Pharmaceutical Technology

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.

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Overview of pharmaceutical quality control steps and implementations

GMPSOP

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.)