After huge changes in the regulatory system, Japan has become the largest market for clinical trials in the Asia-Pacific region for both local and global studies and is now a country of choice in clinical development maps. Previously regulatory lag was a huge hurdle for global drug developers. One good example of such lags is […]

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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 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 require three […]

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Japan is one of the world’s leading markets for cosmetic and personal care products. The experts expect the beauty and personal care products market to grow at a CAGR of 3.5% for the next five years. Along with this, Cosmetics shipments within Japan generates a market value of around 2.7 trillion Japanese yen.  Top reasons […]

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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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Small and Mid-Sized CROs for clinical trials occupy about 44% of the market share of outsourced development works approximately. These CROs are gaining interest and becoming the choice for startups, small and mid-sized pharmaceutical and biological companies. While in the first part of this article series on “Contract Research Organizations For Your Clinical Trials” the […]

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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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Learning about global regulatory requirements and understanding the pathway for approval can help clinical development teams take their global strategy in the right direction. Sharing expertise from regulatory experts for those who need it. (This article was originally published on LinkedIn). It’s no news that we are now living in an era with a tremendous surge […]

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There is always an increasing interest in conducting clinical trials in Japan due to market size, clear regulatory guidelines and a crisp approval process, and other factors. That also calls for adequate awareness about the regulatory process required for starting clinical trials in Japan. Japan is the world’s second-largest single-country pharmaceutical market, accounting for approximately […]

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