JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes In the case of orphan drugs and certain other products that are considered to have particu- larly high medical needs, the examination of the marketing authorisation application for the prod- uct can be granted priority over examination of other products by the examining authority. Prod- ucts that are eligible for this priority examina- tion route include, for example, pharmaceuticals that are designated by the MHLW as products with unmet medical needs pertaining to paedi- atric diseases and antimicrobial resistance, as well as pharmaceuticals and medical devices that are designated by the MHLW as innovative products. The Pharmaceuticals Act also provides for an exceptional abbreviated marketing authorisation application process for certain designated phar- maceuticals and medical devices that satisfy certain criteria prescribed by law, including, for example, that (i) there is urgent need to use the product to prevent the spread of disease or other health hazards that may pose serious effects on the lives and health of the general public, and (ii) there is no other appropriate method avail- able other than to use such product. Currently, the MHLW has designated drugs pertaining to COVID-19 as the products eligible for such abbreviated application process. In the abbre- viated application process, the MHLW has the authority to grant the applicant an extended grace period for submitting certain information and documents required for ordinary marketing
and take other appropriate measures to prevent patients suffering further damage or losses. An applicant for a marketing authorisation must typically complete all clinical trials first and then submit its application with the complete accom- panying data. However, in the case of condition- al early approval for market authorisation for an innovative product exempted for a part of its clinical trials, post-marketing phase IV clinical trials must be performed. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices In general, third parties can access information about applications for marketing authorisations by making a request under Japan’s information disclosure law. Under the Act on Access to Infor- mation Held by Administrative Organs, anyone may request the disclosure of administrative documents held by an administrative organ. Under this law, the MHLW is essentially required to disclose an application for marketing authori- sation if properly requested. However, the appli- cation for marketing authorisation may include or refer to the IP or confidential information of an applicant, and the disclosure of such information to a third party may result in serious damage to an applicant’s rights and competitiveness. Therefore, disclosure of an application is usu- ally made after the relevant sensitive information contained in it has been redacted or masked so that the IP and/or confidential information of an applicant is protected.
authorisation application. 4.2 Regulatory Reliance
As part of the marketing authorisation applica- tion documents, the applicant is required to pro-
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