JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
a registered seller, and explanation of such phar- maceuticals 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 prob- lem 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 prob- lem 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 differ- ent business licences, as appropriate. A distributor of the specially controlled medical devices is required to obtain a business licence for each of its distribution offices. A distributor for the controlled medical devic- es is required to submit a notification of its distribution activity for each of its distribution offices. A distributor of only ordinary medical devices is not subject to such business licensing or notification requirement. The Pharmaceuticals Law, together with the Good Clinical Practice (GCP) ministerial order issued by the MHLW, is the principal law regulating 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. New drugs that have undergone clinical trials and received market- 2. Clinical Trials 2.1 Regulation of Clinical Trials
ing approval in foreign jurisdictions are required to undergo separate clinical trials in Japan. Even for COVID-19 vaccines supplied to Japan, the Japanese government required that a limited number of sepa- rate clinical trials be performed in Japan based on this policy. The MHLW insists that such clinical trials 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. 2.2 Securing Authorisation to Undertake a Clinical Trial To conduct a clinical trial, an applicant (a pharma- ceutical or medical device marketer) must prepare a protocol and receive approval for such protocol from an institutional review board (IRB). A protocol must cover, among other things, the subject material, pur- pose, design, methods, statistical considerations and organisation of the proposed clinical trials. The appli- cant is also required to register the protocol with the MHLW through the PMDA. In practice, the applicant consults with the PMDA informally about its draft pro- tocol before formally registering the protocol with the MHLW. 2.3 Public Availability of the Conduct of a Clinical Trial The website of the National Institute of Public Health discloses certain basic information regarding clinical trials conducted in Japan, including: • the title of the study; • the subject material of the study; • a brief summary of the study; • information about the monetary sponsor, the rel- evant IRB, and other organisations involved; • contact information for the parties involved; and • a summary of the results. 2.4 Use of Online Tools to Support Clinical Trials There is no apparent prohibition on using online tools to support clinical trials, which are generally required to be conducted by doctors or hospitals and include in-person interviews with, and written informed con- sents from, clinical trial subjects. Recruiting clinical trial subjects can be conducted online. In addition,
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