JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
in serious damage to an applicant’s rights and com- petitiveness. Therefore, disclosure of an application is usually 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. 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 particularly high medical needs, the examination of the marketing authorisa- tion application for the product can be granted priority over examination of other products by the examin- ing authority. Products that are eligible for this priority examination route include, for example, pharmaceu- ticals that are designated by the MHLW as products with unmet medical needs pertaining to paediatric diseases and antimicrobial resistance, as well as phar- maceuticals and medical devices that are designated by the MHLW as innovative products. The Pharmaceuticals Act also provides for an excep- tional abbreviated marketing authorisation application process for certain designated pharmaceuticals 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 dis- ease 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 applica- tion process. In the abbreviated application process, the MHLW has the authority to grant the applicant an extended grace period for submitting certain informa- tion and documents required for ordinary marketing
for the product has already been obtained outside of Japan. However, such information is one of the various factors to be considered in the course of the MHLW’s marketing authorisation application examination pro- cess. The MHLW does not necessarily expedite the issuance of the marketing authorisation in Japan even if marketing authorisation for the product has already been obtained outside of Japan. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Pharmaceutical Manufacturers A manufacturing business licence is required in order to manufacture pharmaceuticals in Japan. If a man- ufacturer of an imported product is located outside Japan, that manufacturer will be required to obtain accreditation as a foreign manufacturer. A manufac- turing business licence is granted by the relevant pre- fectural government and such accreditation is granted by the MHLW. Once an application for a manufactur- ing business licence is formally submitted, the pre- fectural government reviews the application and – in most cases – conducts an on-site inspection of the applicant’s manufacturing premises. The period of validity of a manufacturing business licence and an accreditation is five years. Medical Device Manufacturers Unlike pharmaceutical manufacturers, a medical device manufacturer – whether located in Japan or outside Japan – is only required to satisfy a prior reg- istration (ie, registration with the MHLW as a medi- cal device manufacturer). The registration must be renewed every five years. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices In order to market pharmaceuticals or medical devic- es, the initial marketing entity must hold a marketing business licence and have marketing authorisation for
authorisation application. 4.2 Regulatory Reliance
As part of the marketing authorisation application documents, the applicant is required to provide infor- mation regarding the use of the product outside of Japan, including whether a marketing authorisation
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