Tagged with J

Denmark Despite its diminutive size, Denmark boasts a world-renowned healthcare and life science industry containing both household pharma giants as well as a robust network of academia, a host of niche service providers, and a growing throng of biotech start-ups. And with life science exports surpassing EUR 23 billion last year…

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…

Europe Pharma and biotech companies are doubling down on innovation and, often, outsourcing just about everything else. That shift has turned contract development and manufacturing organisations (CDMOs) into critical partners, not just service providers. The sector is booming, but pressure is building fast: demand is surging, capacity is stretched, and new…

Denmark Christian Houborg, General Manager and Senior Vice President of FUJIFILM Biotechnologies Denmark, shares how the Hillerød site has evolved from a legacy facility into a cornerstone of the company’s global CDMO network. From expanding capacity to embracing cutting-edge technologies like AI and digitalisation, FUJIFILM Biotechnologies is setting new standards for…

MEA A selection of top stories coming out of the Middle East and Africa’s pharma sector: Egypt’s Gypto Pharma partners with US drugmaker Dawa to expand the local production of medicines; Jordan’s Hikma makes a USD 1 billion investment pledge for US manufacturing and R&D, and Riyadh-headquartered private equity firm Jadwa…

Europe Lora Fleifel, Director of Global Value Access & Pricing Operations Europe for Oncology at Merck, dissects the promise and pitfalls of the new EU Joint Clinical Assessment (JCA). The JCA aims to harmonise clinical evaluations to help reduce the significant disparities in patient access to innovative treatments that still exist…

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.…

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…

Pharma Legal Handbook 1.Price Control How does price control at ex-factory prices work in your country? There is no control by the government on the sales price of drugs from a market authorization holder to a pharmaceutical wholesaler regardless of whether it is a prescription drug or an over-the-counter drug.   How does…

Pharma Legal Handbook Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Japan, it is important whether a drug or medical device is covered by the NHI (i.e., whether it is listed on the NHI Price List). If it is, the product is eligible for NHI…