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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association.

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Tracking the Drug Trail

Pharmaceutical Technology

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. Europe is favouring 2D data matrix codes to encode information while the US is tending more towards RFID. .

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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. Prev PREVIOUS POST Author: Kazi Hasan Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.