Tag: Japan

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Top 5 Challenges for Shipping Clinical Trial Materials to Japan: How Sponsors and CROs Can Overcome Them

Shipping clinical trial materials, such as ancillaries, medical devices, or Investigational Medicinal Products (IMPs), to Japan requires a thorough understanding of the laws and local regulatory systems. Understanding the challenges for shipping clinical trial materials to Japan begins with recognizing how the country’s regulatory framework differs from most others.  Japan’s clinical trial regulations differ from […]

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Planning Clinical Trials In Japan? Here’s How To Ship Your Ancillaries & Non-IMPs

If you’re planning a clinical trial in Japan, one of the most important (and often overlooked) aspects is how to properly ship your ancillary supplies and non-IMPs. In particular, lab kits, diagnostic devices, and other materials may be required. Therefore, navigating import requirements is not always straightforward. With strict regulations and detailed customs procedures, a […]

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Japan Clinical Trials: Choosing the Right Sites

Japan is quickly becoming one of the most important countries in Asia for clinical research, not just because of its strong healthcare system and regulatory structure, but also due to its growing focus on innovation and patient-centered studies. But running a successful trial in Japan takes more than just choosing a country; it requires selecting […]

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Top 7 Reasons To Choose Japan For Your Clinical Trials

Japan has emerged as a premier destination for clinical trials, attracting global pharmaceutical companies and research organizations due to its advanced medical infrastructure, highly skilled workforce, and robust regulatory framework. With a rapidly aging population and a high prevalence of chronic diseases, Japan offers a unique environment for conducting clinical research. The country’s strict compliance […]

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The Role of IOR & EOR Services In Optimizing Clinical Trials In Japan

The role of IOR & EOR services is becoming crucial in optimizing clinical trials in Japan. Clinical trials are essential for the development of new drugs and medical devices. Japan, being a significant player in the pharmaceutical industry, has become an attractive location for conducting clinical trials. This is due to its diverse patient population, […]

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Marketing Authorization Holder (MAH) & Designated Marketing Authorization Holder (DMAH) For Product Registration In JAPAN

If you plan to register a healthcare product in Japan, previously you would need an In-country caretaker system. After the revision of the Pharmaceuticals and Medical Device (PMC) Act, the Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH).replaces the In-country caretaker system The foreign manufacturer who plans to register their products in Japan […]

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Top 4 Considerations For Registering Nutraceuticals (Food Products) In Japan

Japan has the same regulations and practices for nutraceuticals, food, and beverage goods as any other nation. Legitimate safety regulations, regulatory protectionism, and customs taxes present manufacturers with significant obstacles when they attempt to enter the market. The Ministry of Health, Labour, and Welfare (MHLW) and Consumer Affairs Agency (CAA) are in charge of enforcing the Food […]

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Herbals And Botanical Products Regulations

Globally many consider herbs and botanicals to be natural and therefore healthier and gentler than conventional drugs. Currently, 30% of prescription drugs are herbal and botanical drugs. Herbals and botanicals are used for the treatment and improvement of health and well-being. Many countries use herbal and botanical drugs traditionally for many years to generations. The […]

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