Posts in Regulatory Topics

Illustration of a rejected pharmaceutical batch for import into Japan.
by Stefan Sandström
November 10, 2024

The Essential Guide for Successful Batch Release in Japan

Japan represents one of the world’s most demanding pharmaceutical markets, with rigorous quality standards that go […]
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Illustration depicting ATMP classification and market entry strategies in Japan.
by Stefan Sandström
September 2, 2024

Navigating the ATMP Landscape: What Qualifies as an ATMP and Business Opportunities in Japan

Advanced Therapy Medicinal Products (ATMPs) represent a rapidly evolving field in biotechnology, offering transformative therapeutic solutions […]
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Illustration showing the financial barriers to accessing Cell and Gene Therapies.
by Stefan Sandström
September 1, 2024

The Accessibility Crisis in Cell and Gene Therapies: Implications for Global Health Equity

The rise of Cell and Gene Therapies (CGT) marks a significant advancement in modern medicine, offering […]
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by Stefan Sandström
May 18, 2024

Business Opportunity Seminars at iPark

Seminar date: May 16, 2024   Thanks to its size, technological advancements, and commitment to innovation, […]
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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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