Tagged with Legal Handbook

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 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…

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 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 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 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 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 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 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 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 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/); and the National Health Insurance House (http://www.cnas.ro/).   2. What is…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania in view of obtaining the marketing authorization for a certain medicinal product.  …