JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices The Act on Securing Quality, Efficacy and Safe- ty of Products Including Pharmaceuticals and Medical Devices (the “Pharmaceuticals Law” ), together with related cabinet and ministerial orders, is the primary law that governs pharma- ceuticals and medical devices in Japan. Under the Pharmaceuticals Law, pharmaceuticals and medical devices are in principle subject to the same level of regulation in order to maintain the safety and efficacy of these products. Details of the regulations applicable to pharmaceuticals and medical devices are set out in ministerial orders, administrative guidelines and cabinet orders as explained in the next paragraph. The Ministry of Health, Labour and Welfare (MHLW) is the principal regulatory body for phar- maceuticals and medical devices. The MHLW is the national government body that issues most of the Pharmaceuticals Law-related ministerial orders and administrative guidelines, and drafts relevant cabinet orders. Prefectural governments (ie, independent local governments such as the Tokyo Metropolitan Government) are primarily responsible for monitoring pharmaceutical and medical device marketers, manufacturers and distributors in their respective jurisdictions on behalf of the MHLW. Various business licences for pharmaceutical and medical device market- ers, 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 independ- ent administrative agency that receives financial support from the Japanese government to cov-
er its operational costs, 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 commented on (if any) by the PMDA. Therefore, communica- tion with PMDA officials is key to obtaining new pharmaceutical marketing authorisations. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation If a pharmaceutical or medical device firm vio- lates the Pharmaceuticals Law or any related regulation, the MHLW or a prefectural govern- ment may issue an administrative order to that firm. The recipient may challenge the administra- tive order through an administrative complaint review process provided under the Administra- tive Complaint Review Act. A pharmaceutical 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 competent court in accordance with the Administrative Case Litigation Act. These chal- lenge 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, a few leading generic drug manufac- turers received business suspension orders due to their violations of pharmaceutical regulations, resulting in significant shortages in certain sec- tors of the generic drug market in Japan. 1.3 Different Categories of Pharmaceuticals and Medical Devices Pharmaceuticals are categorised into two class- es: prescription pharmaceuticals and OTC phar- maceuticals. Prescription pharmaceuticals may only be used by doctors or used in accordance with a doctor’s prescription. OTC pharmaceuti-
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