On the 16th of October, it was announced that FUJIFILM Toyama Chemical Co., Ltd. filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan® Tablet (generic name: favipiravir) to the Ministry of Health, Labour and Welfare in Japan to include additional indication and other items relating to novel coronavirus infections, COVID-19.
On the 15th of October,it was announced that Chugai Pharmaceutical Co., Ltd. filed an application with the Ministry of Health, Labour and Welfare (MHLW) for risdiplam as the first oral drug for the treatment of spinal muscular atrophy (SMA). Risdiplam is a survival motor neuron-2 (SMN2) splicing modifier and received orphan drug designation from the MHLW on Mar 27, 2019.
On the 15th of October, Pharmaceutical Safety and Environmental Health Bureau Pharmaceutical Evaluation Division of Ministry of Health, Labour and Welfare published the draft of The Japanese Pharmacopoeia 18th edition for public comments. They are accepting public comments until the 5th of November.