The PMDA has some stringent data requirements, which make Japan unique. Japan’s regulatory environment is significantly more complicated than any other country. The level of accuracy and details required by the Japanese regulatory authority is sometimes even greater than the US FDA (the United States Food and Drug Administration), the EMA (the European Medicine Agency) or any other pharmaceutical regulatory agency. Japan's Pharmaceutical market is one of the largest markets in the world and the market value is about $95 billion as per the data of the ministry of Health, Labour and Welfare (MHLW). This market is expected to expand at a CAGR of 1.06% from 2022 to 2027. In Japan the PMDA office of biologicals provide consultations concerning clinical trials of new biologic drugs and handle biotechnology medicines, which include biosimilar and biological products. The purpose of this review article is to provide a basic understanding of legal regulatory systems, marketing authorization application, the Pharmaceutical and Medical Device Agency (PMDA) review process, timing requirements in Japan, with a focus on biological drug products for human use.
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