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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Getting the study drug at the right time is challenging for any clinical trial, and this is more prominent with multi-regional clinical trials. To import and have the IMPs and ancillaries at the clinical trial sites in time, the sponsors need to have the right people, processes, facilities, and technology in place. Generally, the sites […]

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The conduct of clinical trials is a demanding process. This requires not only the hiring of resources to perform various activities but also the material to support to actually execute different activities and processes. Some of these materials can be investigational products. But, a vast number of products could be non-investigational products required for the […]

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In the last few decades, there is a growing appreciation for nutraceuticals and dietary supplements’ role in Japan to prevent health risks and improve health quality. The Japanese nutraceutical industry, such as dietary supplements and functional foods, grew at an average of 15 percent per year. In 2019, Japan’s health-related food market was the third-largest […]

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The drug approval process in Japan is less complex and easy when compared to some other countries beyond the language barriers. The PMDA along with regulatory aspects also provides consultation to sponsors to help understand the requirements and the stepwise drug approval process. This makes many manufacturers choose Japan as their drug market. Japan’s pharmaceutical […]

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Regulatory agencies of various countries are providing benefits & regulatory incentives for orphan drugs such as faster approvals, fee concessions, and financial benefits, and many more. These incentives are to support and encourage pharma companies to work upon developing orphan drugs or medical devices for rare diseases. The countries that provide regulatory incentives include the […]

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There is an increase in interest for the drug developers to conduct clinical trials in Japan due to huge market size, clear regulatory guidelines, a crisp approval process, and other such factors. This calls for adequate awareness about the regulatory process required to start clinical trials in Japan. Japan is the world’s second large pharmaceutical […]

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