The drug approval process in Japan is less complex and easy when compared to some other countries beyond the language barriers. In addition to regulatory considerations, the PMDA offers sponsors consultation to assist them in understanding the prerequisites and the detailed procedure for drug approval. As a result of this positive change, many manufacturers choose […]

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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. Note: This information was last updated in […]

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