Tagged with japan

Japan An overview of the new medicines approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) between April and November 2022. See the 2021 data here and the full PMDA approval archive here. Hecho conVisme Infographic Maker

Japan MSD KK’s Fumitaka Noji, writing in the January 2023 edition of DIA’s Global Forum magazine, outlines some of the key upgrades that Japan’s innovation ecosystem needs to become globally competitive once again, namely around strategy and information, investment, and finding qualified experts.   Although the importance of open innovation in…

Japan Pfizer’s Kaneko Miyuki, writing in the September 2022 edition of DIA’s Global Forum magazine, shines a light on Japan’s new emergency approval system for pharmaceuticals. Enacted in the wake of the COVID-19 pandemic, Japan hopes that this new regulation will allow for a more rapid and agile response to future…

Pharma Legal Handbook The key facts about biosimilars and biologics in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here.   1. Are biosimilar medicines considered the same as generic medicines in your country? A…

Pharma Legal Handbook The key facts about localization in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. Are there any rules or regulations requiring and/or encouraging localization in your…

Pharma Legal Handbook Keen to learn more about cannabinoid drugs, medicinal cannabis and opioid drugs in Japan? Read on! Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   Cannabinoid Drugs 1. Are…

Pharma Legal Handbook The ins and outs of orphan drugs & rare diseases in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What is the definition of Rare Diseases…

Pharma Legal Handbook The key facts about regulatory reforms in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. Are there proposals for reform or significant change to the…

Pharma Legal Handbook The legal framework for patents and trademarks in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What are the basic requirements to obtain patent and…

Pharma Legal Handbook All legal aspects surrounding product liability in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What types of liability are recognized in your jurisdiction? Contract…

Pharma Legal Handbook A brief overview of the situation regarding traditional medicines and OTC products in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What are the regulatory requirements…

Pharma Legal Handbook Marketing, manufacturing, packaging & labeling, advertising in Japanese Pharma – a comprehensive legal overview. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What is the authorization process for…