Tagged with tech

Hong Kong For anyone seeking a place where world-class science and a balanced lifestyle can coexist, Hong Kong offers a uniquely compelling proposition. As China’s pharmaceutical landscape expands into innovative biologics, SPH Biotherapeutics (HK) – an R&D affiliate of Shanghai Pharma – is advancing a dual-targeting CAR-T platform with early clinical results…

Saudi Arabia At the helm of Medtronic’s operations in the Middle East, Khalil Jamaleddine brings over three decades of experience to a region undergoing profound healthcare transformation. From building the company’s early presence in a small Beirut office to leading its strategic consolidation across Saudi Arabia and beyond, his journey mirrors Medtronic’s…

Puerto Rico Backed by world-class expertise, cutting-edge technology, and an ecosystem built on collaboration, the Medical Device Cluster is redefining what it means for Puerto Rico to be a global leader in medical innovation. From scaling high-precision manufacturing to pioneering workforce development, the island is setting new industry benchmarks. Puerto Rico is…

Europe With the proposed Biotech Act, the European Commission (EC) is aiming to boost the EU biotech industry’s competitivity in the face of major rivals like the US and China. Tackling the EU bloc’s regulatory complexity and its barriers to funding is not an easy task, but biotech stakeholders eye the…

Sweden Even though the development of these treatments takes time, there are many capable people continuing to push the field forward. I believe that lecanemab, BioArctic, and others dedicated to this area will keep innovating, learning, and improving—ultimately leading to better outcomes for patients with Alzheimer’s. Lars Lannfelt, co-founder and board…

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…

Pharma Legal Handbook Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Marketing authorization holders of products designated as subject to the Cost-Effectiveness Evaluation System are required to conduct an analysis of the cost-effectiveness evaluation of the designated products and submit a report describing the analysis data. With…

Pharma Legal Handbook In addition to the clinical data obtained through clinical studies please list the data required for   a. Market approval In general, an applicant for marketing authorization for a new drug is required to submit the information and data below. Documents a. Origin or background of discovery, condition of use…