Tagged with Japan

Japan We have evolved well beyond the traditional CRO model Global biopharma companies are looking at Japan through a different lens, seeking partners that can navigate an increasingly complex regulatory landscape while supporting integrated development across Asia. At the heart of that evolution is CMIC, whose President and Representative Executive Officer,…

APAC For two decades the case for running a clinical trial in Asia was essentially arithmetic: the same study, for less money. That argument has not gone away, but it is no longer the one APAC’s own CRO leaders make. Asia Pacific is now the only region in the world where…

Global New Takeda CEO Julie Kim inherits a firm with flatlining growth and generic competition eating away at its lead drug’s revenues. Will three major new launches over the next year and swingeing job cuts be enough to revive its fortunes? Now one of just two female Big Pharma CEOs (along…

Japan Patients in Japan deserve the same access to innovative treatments that patients in other markets have. Accelerating that access is what drives us Noriyuki Takai, CEO of EPS Corporation, outlines the CRO’s mission to help address Japan’s drug lag and drug loss by supporting faster access to innovative medicines. He…

Japan Hideyasu Matsuda and Toru Fujieda of the Japan CRO Association argue that, thanks to an updated regulatory framework, Japan is becoming one of the most competitive and operationally attractive clinical development destinations in the world.   Japan is an attractive clinical trial destination from a cost, quality, and speed perspective…

Japan Dr Toshiaki Nagafuji leads the Innovative Drug Development Business (IDDB) at Linical after a career spanning discovery and research at Chugai and clinical development, project management, and business development at Shionogi. At Chugai, he also served as a visiting professor at Brain Research Institute, Niigata University and a visiting researcher…

Japan Asia is emerging as a critical frontier in oncology research, yet much of global drug development continues to overlook the region’s specific clinical needs. At the National Cancer Center Japan, Kenichi Nakamura is working to change that dynamic through ATLAS, a pan-Asian clinical trial network designed to enable more coordinated,…

Pharma Legal Handbook What are the pricing models, processes and principles for originator drugs? Drugs are provided by a medical institution or pharmacy to a patient based on the NHI Drug Price (a patient pays 10%, 20% or 30% (depending on age and other conditions) of the NHI Drug Price). As detailed in…

Japan Writing in the September 2025 edition of DIA’s Global Forum magazine, Seiko Usami, Shinichi Noda, Daisuke Koga, and Naoyuki Yasuda of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s regulatory body, outline the benefits for global pharma of including Japan in their drug development activities.   Japan is one of…

Japan Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) concluded FY 2024‑25 (April 2024–March 2025) with a total of 148 approval decisions, including no less than 66 new active ingredients and 82 lifecycle updates, including new indications, pediatric expansions, and formulation changes. Innovation Snapshot A steady stream of orphan and rare‑disease designations—including sparsentan for primary…

Pharma Legal Handbook 1.Please make a general introduction to the public health sector in your country and its organization (a)       The overview of the public health sector In Japan, the universal health insurance system allows citizens to receive medical services anytime, anywhere. The system is run by insurance premiums and other funds collected…

Pharma Legal Handbook Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The MHLW, the PMDA, and the Central Social Insurance Medical Council are responsible for public health. Their respective roles are explained in the response to Question I.-1.   2.…