Summary and Review of New Drugs Approved by FDA, EMA and PMDA in 2017(Ⅰ)

In 2017, Food and Drug Administration (FDA) approved forty-six new molecular entities/new biologic license applications, thirty-five of which were granted the first-ever regulatory approval worldwide. European medicines agency (EMA) issued market authorizations to a total of fifty-one new medicinal products, four of which were new approvals globally. Pharmaceuticals and Medical Devices Agency (PMDA) approved twenty-three new medicinal products and three of them are not yet approved in any other countries. The R & D progression, outcomes of clinical research and market expectation regarding these newly approved medicinal products were summarized so as to provide a concise reference to all interested parties.