JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
cals can be purchased at drug stores or other non-licensed stores. OTC pharmaceuticals are further classified into several sub-categories and, depending on the relevant sub-category, may have certain sales restrictions. • Class one OTC pharmaceuticals – can only be sold by a licensed pharmacist, with a man- datory explanation of the key points relating to such pharmaceuticals to be given by the pharmacist to a purchaser at the time of sale. • Class two OTC pharmaceuticals – can only be sold by a licensed pharmacist or a reg- istered seller (who has passed a registered seller examination held by a prefectural gov- ernment), and explanation of such pharma- ceuticals at the time of sale is recommended. • Class three OTC pharmaceuticals – can be sold without the presence of a licensed phar- macist or a registered seller, and explanation of such pharmaceuticals by the seller is not legally required or recommended. Medical devices are categorised into three classes: • specially controlled medical devices (medical devices that are highly invasive to the patient, and, if a problem were to occur, there is a risk that it would directly affect the patient’s life or pose a relatively high risk to the human body; classes III and IV of the Global Harmonisation Task Force (GHTF) international classification structure); • controlled medical devices (medical devices for which the risk to the human body, even if a problem were to occur, is considered to be relatively low; class II of the same); and • ordinary medical devices (medical devices for which the risk to the human body, even if a problem were to occur, is considered to be extremely low; class I of the same).
Depending on the relevant class of medical devices, a marketer and a distributor will need to obtain different business licences, as appro- priate. A distributor of the specially controlled medical devices is required to obtain a busi- ness licence for each of its distribution offices. A distributor for the controlled medical devices is required to submit a notification of its distribu- tion activity for each of its distribution offices. A distributor of only ordinary medical devices is not subject to such business licensing or notifi- cation requirement. The Pharmaceuticals Law, together with the Good Clinical Practice (GCP) ministerial order issued by the MHLW, is the principal law regu- lating clinical trials. The MHLW and the PMDA are the main regulatory authorities that oversee clinical trials. The MHLW generally requires all drugs to be tested in clinical trials conducted in Japan and operated by hospitals located in Japan, and to be subject to marketing authorisations in Japan. Even new drugs that have undergone clinical tri- als and received marketing approval in foreign jurisdictions are required to undergo separate clinical trials in Japan in order to verify such drug’s effectiveness and safety when given to Japanese people. Even for COVID-19 vaccines supplied to Japan, the Japanese government required that a limited number of separate clini- cal trials be performed in Japan based on this policy. The MHLW insists that such clinical tri- als are necessary and that they must be carried out in Japan in order to study the differences in pharmacology due to race, lifestyle, etc, in Japan with those in a foreign country. 2. Clinical Trials 2.1 Regulation of Clinical Trials
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