??Is an earlier drug approval and commercialization in Japan possible?
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Japan's approval review period has been significantly shortened than the past
There is a view among overseas pharmaceutical companies that "clinical development takes rather longer time in Japan," but on what basis is this assertion based?
The graph below shows the median review time required for new drug approval by six regulatory authorities in Europe, the United States, Canada, Switzerland, Australia, and Japan (latest information published in July 2024). The review period is measured from the date of submission to the date of approval. Japan's review agency for new drug approval has the shortest time among the countries/regions surveyed.
Furthermore, to improve access to new drugs for Japanese patients, Japanese regulatory authority is actively pursuing initiatives to expedite new drug approvals, such as increasing the prescribed timing of new drug approvals from four times a year to seven times a year, and, as mentioned in a previous article-1, previous article-2, the timing of drug price listings will also be revised soon from four times a year to seven times a year.
In the US and the EU, there is a system in place to approve drugs for rare diseases or serious diseases with high medical need based on the results of clinical trials other than confirmatory clinical trials, without waiting for the results of confirmatory clinical trials. This is one example of a measure to speed up new drug approval in Europe and the United States, but Japan also has an accelerated review system that provides new drug applicants with benefits similar to those of the US accelerated approval system and the EU conditional approval system. The next section will explain the system that promotes the approval of drugs for rare diseases in Japan.
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Specific measures by Japanese authorities to promote the early approval of innovative and orphan drugs
According to estimates by the PMDA, the review time lag between Europe and the US is being eliminated*. However, issues of drug lag and drug loss still remain, so as one of the measures, the following system has been established in Japan.
Japan has introduced several systems aimed at promptly delivering innovative new drugs and orphan drugs, for which there are no alternative medications or treatment methods, to patients, such as the "Sakigake Designation System" and the "Orphan Drug and Medical Device Designation System."
The table below compares the orphan drug systems of Japan, the US, and the EU.** Each regulatory authority has introduced various preferential treatment measures for orphan drugs. A unique feature of Japan's rare disease drug system, which is not available in the United States or the EU, is the priority review. In Japan, if a drug is designated as an orphan drug, the approval review period, which would take 12 months under the regular review process, is shortened to nine months by default***.
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Supporting accelerated clinical development and commercialization in Japan
Overseas pharmaceutical companies often say that they find it difficult to understand how to apply to Japan's accelerated review system, introduced in this article, and how to deal with other regulatory requirements, which is an obstacle when considering conducting drug development in Japan. If you have any questions about drug development in Japan, please feel free to consult with us EPS to be familiar with the Japanese review system. And if you expect conducting drug development in Japan, even if you do not have a business subsidiary in Japan, we can support you in your every interactions/communication with authorities related to your clinical development in Japan as an in-country clinical care-taker (ICCC) under Japanese regulations.
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Upcoming topics?
In the next article, we will share information about the advantages of entering Japan for overseas pharmaceutical and startups. Refer to our LinkedIn or website for the schedule of next EPS’s international conventions. Follow our LinkedIn!
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Source: Ministry of Health, Labour and Welfare website The information below has been quoted and translated.
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