Search Results for Health Technology Assessment

Showing 1 – 11

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

Drug Reimbursement in Canada By George Wyatt, MBA - Published 01 September 2017

This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place.

Categories: Features, Canada, Health Canada, Biologics and biotechnology, Drugs, Reimbursement

Tags: Reimbursement, Coverage, Health Technology Assessment, HTA, Common Drug Review

The Value of Health Technology Assessment Scientific Advice By Amina Udechuku, PhD, Matthew William Bending, PhD, MSc - Published 23 August 2017

In recent years, particularly in Europe, a paradigm shift in the regulatory and Health Technology Assessment (HTA) environment has led to an increase in multi-stakeholder acceptance of integrated scientific advice. This article discusses how using integrated scientific advice can support companies in optimizing their product development programs and generate evidence relevant to regulators, HTA bodies and payers.

Categories: Features, Canada, Europe, US, EMA, FDA, NICE, Biologics and biotechnology, Drugs

Tags: Health Technology Assessment, HTA

European Commission Explores the Future of HTA Cooperation By Zachary Brennan - Published 21 October 2016

The European Commission on Friday opened a consultation to consider the views of a number of different stakeholders on the future of health technology assessments (HTAs) across the EU member states.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: HTA cooperation, health technology assessment

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

The Key to EU Market Access for Pharmaceutical Companies: Early Engagement By Michael Mezher - Published 18 March 2015

The path to regulatory approval can be long and arduous. It can also be especially difficult for smaller companies to navigate. But a new report finds that early input from health authorities can help make the process more straightforward.

Categories: News, Europe, EMA, NICE, Biologics and biotechnology, Clinical, Communication, Drugs, Government affairs, Regulatory strategy, Reimbursement, Research and development, Submission and registration

Tags: HTA, Health Technology Assessment, scientific advice

Study Claims German Dossier Requirements Could Improve Open Access to Trial Data By Michael Mezher - Published 03 March 2015

A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports.

Categories: News, Europe, EMA, Clinical, Ethics, Government affairs, Regulatory strategy, Reimbursement, Submission and registration

Tags: IQWiG, Health Technology Assessment, AMNOG, Clinical Trial Transparency

German Price Watchdog Says ‘No’ to 3 Cancer Drugs By Michael Mezher - Published 23 January 2015

The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month.

Categories: News, Europe, Clinical, Prescription drugs, Reimbursement

Tags: IQWiG, Health Technology Assessment, HTA, G-BA, Federal Joint Committee, AMNOG

Europe-wide HTA Database Opened for HTA Agencies By Alexander Gaffney, RF News Editor - Published 09 November 2012

Tags: EVIDENT, Health Technology Assessment, HTA, Latest News, database, evidence, EU

New Draft European HTA Guidelines Released By Louise Zornoza, RegLink - Published 04 September 2012

Categories: Regulatory Update

Tags: EYnetHTA, Health Technology Assessment, HTA, EU

European Commission: Consultation on Stakeholder Participation In HTA Network By Louise Zornoza, RegLink - Published 09 May 2012

Categories: Regulatory Update

Tags: Directive 2011/4, Health Technology Assessment, Stakeholder, HTA, CER, European Commission, input