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Japan: Medical product regulatory regime

Masanori Tosu

On November 25 2014, an amendment to the Pharmaceuticals and Medical Devices Law (the Law) came into effect and introduced important changes to Japan's medical products regulatory regime, including the establishment of regulations for regenerative medical products (for example, regenerative medicines using iPS cells). Indeed, since the Minister of Health, Labour and Welfare issued the first marketing authorisations for two regenerative medical products on September 18 2015, the medical products business in Japan and its regulation have received a good deal of attention.

Generally, in order to market medical products (now including regenerative medical products) in Japan, two types of authorisation must be obtained: (i) authorisation to market the relevant medical product (Product Marketing Authorisation) and, (ii) a business licence to operate as a marketing authorisation holder (MAH licence). To obtain a Product Marketing Authorisation, the subject medical product must be examined by the relevant governmental authority which reviews product-relevant information, including clinical data. This is a time-consuming process. Once the Product Marketing Authorisation is issued, the MAH-licensed entity becomes fully responsible for the quality, efficacy, and safety of the relevant product.

Foreign manufacturers of medical products that wish to market their products in Japan typically select one of two business structures under the existing regulations. In the first structure, a Japanese MAH-licensed entity obtains Product Marketing Authorisation for the foreign manufacturer's medical product, and thereafter the foreign manufacturer exports that product to the MAH-licensed entity. In the second structure, the foreign manufacturer itself obtains an exceptional Product Marketing Authorisation. However, in this case, the foreign manufacturer must appoint a Japanese MAH-licensed entity as its designated MAH-licensed entity. That Japanese entity must carry out all the required procedures, including submission of necessary applications, on behalf of the foreign manufacturer, and is responsible for all post-marketing vigilance activities. Where the second structure is used, the foreign manufacturer assumes almost the same responsibility as the MAH-licensed company in the first structure. The decision on which structure to implement will depend on various factors, including the relationship between the foreign manufacturer and the Japanese MAH-licensed entity.

As there are many other regulations relevant to the marketing of medical products in Japan, it is important that manufacturers of medical products ensure they are fully informed of the applicable regulations and their responsibilities under the Law.

Masanori Tosu

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