Search Results for EUnetHTA

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EMA, EUnetHTA Sign Off on Three-Year Work Plan By Michael Mezher - Published 13 November 2017

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Reimbursement, Submission and registration

Tags: EUnetHTA, HTA, Health Technology Assessment, Parallel Advice

European Regulatory Roundup: New Gateway for Parallel Consultations on Marketing Authorizations, HTAs (6 July 2017) By Nick Paul Taylor - Published 06 July 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: EUnetHTA, type II variations, ATMPs

European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016) By Nick Paul Taylor - Published 01 September 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: EUnetHTA, 3D modeling of heart disease, Genentech, Herceptin

Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps By Daniel Muscionico, PharmD, MPH, MBA, Paloma Grasser, MTIM, BSc, Rosa Mouchotte, MSc, RAC, Anne Rambaud - Published 29 April 2016

This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers who would like to enter this geographical market. In addition, solutions to maximize the product development strategy are discussed with the intention of bridging regulatory and market access gaps.

Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory strategy, Reimbursement

Tags: Health technology assessment, HTA, Reimbursement, Market access, EUnetHTA, Target product profile

EMA, Payors Team up to Speed up Assessments of Medicines By Alexander Gaffney, RAC - Published 25 June 2014

In the EU, a product must clear two hurdles before it can reach patients. First, it must be approved by regulators, such as the European Medicines Agency (EMA), which determines if a product is safe and effective. Thereafter, the product is evaluated by health technology assessment (HTA) bodies, which determine if the product is suitable for reimbursement according to the standards of various countries.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs

Tags: HTA, EUnetHTA, EPAR, EPARs, Payors, HTA