Posts in Regulatory Topics

A vibrant night scene of a futuristic cityscape in Japan with skyscrapers illuminated by neon lights, featuring a bustling street with diverse pedestrians and holographic signs.
by Stefan Sandström
April 23, 2024

Business Opportunity: Strategic Perspectives on Reducing Drug Lag in Japan’s Pharmaceutical Sector

Japan presents a unique landscape for pharmaceutical companies, both domestic and international. The recent study published […]
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Wide-format illustration depicting ISO 13485's impact on the medical device industry, with navy blue, sand, and pink colors, featuring medical devices, ISO certification logo, and subtle Japanese elements like cherry blossoms and Mount Fuji silhouette.
by Stefan Sandström
February 28, 2024

ISO 13485 in Japan – the Global Standard for Medical Device Quality

The medical device industry demands the highest standards of quality and safety for its poducts. ISO […]
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An illustration featuring a central origami figure in gold, symbolizing the concept of 'Software as a Medical Device' (SaMD) against a minimalistic background. The design merges technology and healthcare through an elegant origami representation.
by Stefan Sandström
February 14, 2024

SaMD and PMDA – Japan’s Fast Track Policies to Expedite SaMD Registration

Overview:  Introduction Six-month review process priority registration expanded PMDA support innovative drug consultation early application feedback […]
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An artistic graphic showing an overview of the Marketing Authorization Holder (MAH) system in Japan with icons representing approval processes, quality assurance, and post-marketing surveillance.
by Stefan Sandström
February 14, 2024

MAH Japan: A Strategic Guide for Navigating the System

Understanding the MAH Japan System In Japan, the Marketing Authorization Holder (MAH) is central in the […]
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This compelling photo-realistic collage visually narrates the innovative process of TIL therapy in cancer treatment. It begins with the extraction of immune cells from a tumor, depicted on the left with a detailed image of a cancerous mass. The focus then shifts to the center, where a laboratory environment is shown, symbolizing the critical phase of cell expansion. Finally, on the right, the reinfusion of these cells into a patient is portrayed, completing the therapeutic cycle. Each step is vividly illustrated, providing a comprehensive understanding of TIL therapy's potential to transform cancer care. This image serves as an educational and engaging visual aid for professionals and enthusiasts in the fields of oncology, immunotherapy, and medical research.
by Stefan Sandström
February 2, 2024

TIL Therapy in Japan Biopharma Landscape

In the dynamic and ever-evolving field of oncology, Tumor-Infiltrating Lymphocytes (TILs) represent the latest in innovation […]
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Minimalistic wide image of Japan's pharmaceutical sector changes, with a stylized Japanese landscape including Mount Fuji and cherry blossoms, foregrounded by symbolic icons like a partially opened door and pharmaceutical symbols.
by Stefan Sandström
January 30, 2024

Japan’s Drug Regulation Overhaul – Your Golden Opportunity

The recent regulatory changes in Japan’s pharmaceutical sector present a significant opportunity for non-Japanese companies. By […]
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Foreign pharmaceutical executive and Japanese CRO team collaborating on clinical trials.
by Stefan Sandström
January 8, 2024

Partnering with Japanese CROs: A Strategic Imperative for Pharma Expansion in Japan CHECKLIST

Expanding your pharmaceutical operations into Japan is a strategic move with an immense growth potential. However, […]
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From Tokyo Skylines to Biopharma Visions: The Evolving Face of Japan's Medical Industry
by Stefan Sandström
December 27, 2023

Pharma Japan and Strategic Opportunities for Overseas Companies

A Thriving Landscape in Japan’s Pharma Sector Pharma Japan and Strategic Opportunities are plentiful in Japan. […]
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Wide-format illustration depicting a futuristic Japanese cityscape, showcasing advanced biotechnology, green energy solutions, and sustainable urban development, symbolizing Japan's Bioeconomy Strategy 2030.
by Stefan Sandström
December 20, 2023

Japan’s Bioeconomy Strategy 2030 Under the Skin: Opportunities and Challenges

Japan’s Bioeconomy Strategy 2030 marks a transformative approach to integrating biotechnology into Japan’s economic fabric. It’s […]
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Graphic showcasing Japan's biopharmaceutical industry transformation with key strategic government initiatives and market trends.
by Stefan Sandström
November 17, 2023

Japan’s Biopharmaceutical Industry Revitalization: A Strategic Turnaround

Once a flourishing beacon of innovation and global leadership, Japan’s pharmaceutical industry has encountered significant headwinds […]
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