JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
ditional early approval for market authorisation (an expedited process). Variation of a Marketing Authorisation Variation of a marketing authorisation – such as a change in the therapeutic indication, formulation, dosage, patient population, packaging or labelling – requires the marketing authorisation-holder to com- plete a formal process. Depending on the material- ity of the change, the variation may require approval from the relevant authority or the mere submission of a report. Transferral of a Marketing Authorisation It is permissible for market authorisation to be trans- ferred from the current marketing authorisation-holder to a transferee. A transferee of a marketing authorisa- tion must notify the relevant authority of the transfer, at least one month prior to the date of transfer. The transferee must attach a document evidencing the transfer of the marketing authorisation from the trans- feror (eg, a short-form sale and purchase agreement) and a supply agreement with a foreign manufacturer if the product is imported from the foreign manufacturer. The transferee must, in addition to obtaining market- ing authorisation, obtain a business licence to market the pharmaceuticals. In the case of a transfer of the marketing business of a pharmaceutical product, the business transferee is required to apply for the mar- keting business licence well in advance so that it is issued on or before the effective date of the business transfer. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The Pharmaceuticals Law provides for an exceptional procedure to allow the importation of a pharmaceuti- cal or medical device that has received foreign mar- keting authorisation for compassionate use if: • the foreign marketing authorisation was obtained in a country with a marketing authorisation system equivalent to the system in Japan; • immediate use of the pharmaceutical or medical device is necessary to prevent a pandemic that could cause death or serious harm to the health of Japanese citizens; and
• the pharmaceutical or medical device is specifically designated under an administrative order. This special procedure was once used to import an influenza vaccine produced by a foreign manufacturer. It is also used for vaccines and therapeutic drugs for COVID-19 that are produced by foreign manufacturers and supplied for use in Japan. 3.6 Ongoing Obligations Imposed by Marketing Authorisations After the marketing of a pharmaceutical or a medi- cal device commences, the marketing authorisation- holder is required to conduct post-marketing pharma- covigilance and technovigilance. If any issue relating to the effectiveness or safety of the marketed phar- maceutical or medical device is discovered during the post-marketing authorisation surveillance period, the marketer must conduct a pharmaceutical or medical device recall campaign, report the discovery to the PMDA, issue public notices, and take other appro- priate measures to prevent patients suffering further damage or losses. An applicant for a marketing authorisation must typi- cally complete all clinical trials first and then submit its application with the complete accompanying data. However, in the case of conditional early approval for market authorisation for an innovative product exempted for a part of its clinical trials, post-market- ing phase IV clinical trials must be performed. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations In general, third parties can access information about applications for marketing authorisations by mak- ing a request under Japan’s information disclosure law. Under the Act on Access to Information 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 authorisation if properly requested. However, the application for mar- keting authorisation may include or refer to the IP or confidential information of an applicant, and the dis- closure of such information to a third party may result
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