Tagged with Health

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…

Pharma Legal Handbook Are there any Managed entry agreements in place in your country? (If so, please list them) No.   For each Individual Managed entry Agreement Describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it. N/A   When should this Managed Entry Agreement be considered?…

Pharma Legal Handbook Which are the main actors involved in public procurement and tendering? Please see the response to Question II.-7.   What are the main characteristics of the public procurement and tendering system? Japan has established voluntary measures, such as tendering procedures based on stricter standards than those in the WTO-GPA, for…

Pharma Legal Handbook Please describe the main cost containment policies in place in your country and their fundamental principles   a. Pricing and impact of generic/biosimilar approval (i)  Pricing Generics and biosimilars are priced lower than their branded equivalents, reflecting lower R&D costs. When a generic drug is first listed on the NHI…

United Kingdom UK Prime Minister Keir Starmer’s government continues its push to overhaul the country’s iconic National Health Service (NHS). After originally announcing plans to restructure NHS England, the body that manages the NHS in England, it has now decided to eliminate it altogether. In a move that Starmer said would increase…

Saudi Arabia Dr Nasreen Alfaris, a leading Endocrinology, Diabetes, and obesity physician consultant in Saudi Arabia, shares insights into the evolving landscape of obesity medicine in the Kingdom. She discusses her role in establishing the Saudi Obesity Medicine Fellowship Program, the significant strides made in obesity awareness and treatment, and Saudi Arabia’s…

Saudi Arabia Saudi Arabia is rapidly transforming into a key battleground for the consumer healthcare industry, and Haleon is positioning itself at the forefront of this shift. With a growing appetite for innovation, a highly engaged consumer base, and a regulatory landscape that demands agility, the company is reshaping its strategy to…

Saudi Arabia Björn Bodenstein, Managing Director of Siemens Healthineers Saudi Arabia, explores the company’s commitment to supporting Saudi Vision 2030 through innovation, digital transformation, and strategic partnerships. By addressing healthcare accessibility, advancing sustainability, and nurturing local talent, Siemens Healthineers aims to play a transformative role in the Kingdom’s healthcare landscape.   Our…