JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the “Pharmaceuticals Law”), together with related cabinet and ministerial orders, is the prima- ry law that governs pharmaceuticals and medical devices in Japan. Under the Pharmaceuticals Law, pharmaceuticals and medical devices are in principle subject to a high level of regulation in order to ensure the safety and efficacy of these products. The Phar- maceuticals Law also governs cosmetics and quasi- pharmaceuticals, both of which are subject to a lower level of regulation. Details of the regulations applicable to pharmaceuticals and medical devices are set out in ministerial orders, administrative guidelines and cabi- net orders. The Ministry of Health, Labour and Welfare (MHLW) is the principal regulatory body for pharmaceuticals and medical devices. The MHLW is the national gov- ernment body that issues most of the Pharmaceuti- cals Law-related ministerial orders and administrative guidelines, and drafts relevant cabinet orders. Pre- fectural governments (ie, independent local govern- ments such as the Tokyo Metropolitan Government) are primarily responsible for monitoring pharmaceu- tical and medical device marketers, manufacturers and distributors in their respective jurisdictions. Vari- ous business licences for pharmaceutical and medi- cal device marketers, manufacturers and distributors are also issued by the prefectural governments, while marketing authorisations and other product-related approvals are generally handled directly by the MHLW. The Pharmaceuticals and Medical Devices Agency (PMDA), a Japanese independent administrative agency, also plays a key role in reviewing marketing authorisation applications for new pharmaceutical and medical devices. Applications for new pharmaceutical marketing authorisations are first reviewed and com- mented on (if any) by the PMDA. Communication with PMDA officials is key to obtaining new pharmaceutical marketing authorisations.
1.2 Challenging Decisions of Regulatory Bodies If a pharmaceutical or medical device firm violates the Pharmaceuticals Law or any related regulation, the MHLW or a prefectural government may issue an administrative order to that firm. The recipient may challenge the administrative order through an admin- istrative complaint review process provided under the Administrative Complaint Review Act. A pharmaceuti- cal or medical device firm served with an administra- tive order may also commence a legal action for the revocation of the administrative order with a compe- tent court in accordance with the Administrative Case Litigation Act. These challenge procedures are also generally applicable in cases involving the issuance of administrative orders for violations of laws concerning other regulated products (eg, certain food products). Recently, several leading generic drug manufacturers received business suspension orders due to violations of pharmaceutical regulations. This has resulted in significant shortages of certain generic drugs in the Japanese market. 1.3 Categories of Pharmaceuticals and Medical Devices Pharmaceuticals are categorised into two classes: prescription pharmaceuticals and OTC pharmaceuti- cals. Prescription pharmaceuticals may only be used by doctors or used in accordance with a doctor’s pre- scription. OTC pharmaceuticals can be purchased at drug stores or other non-licensed stores. OTC phar- maceuticals are further classified into several sub-cat- egories 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 manda- tory 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 registered seller (who has passed a registered seller examination held by a prefectural government), and explanation of such pharmaceuticals at the time of sale is recom- mended. • Class three OTC pharmaceuticals – can be sold without the presence of a licensed pharmacist or
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