Spring Intro 2023

23/03/2023

Drug development programme

Drug discovery •Patent registration •Non-clinical studies

Regulatory approval & Country HTA submission

EMA Regulatory submission

EUnetHTA Relative

Life cycle management; •new indications, •new formulations

Clinical trials •Phase 1&2 •Phase 3 Early dialogue (parallel consultation)

Effectiveness Assessment

Early Access programmes

The Organisation for Professionals in Regulatory Affairs

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EUnetHTA-EMA Collaboration: JA 3 (2016-2020) objectives

• To define and implement a sustainable model for the scientific and technical cooperation on Health Technology Assessment (HTA) in Europe. • Increase the use, quality and efficiency of joint HTA work at the European level. EUnetHTA will support evidence-based, sustainable, and equitable choices in healthcare and health technologies and support re-use in regional and national HTA reports and activities. • To develop a voluntary, sustainable European Collaboration on HTA, the model focusses on supporting Members States in receiving HTA-relevant information that is objective, reliable, timely, and comparable. The collaborative production of structured HTA core information, including rapid HTAs, will be decentralised.

The Organisation for Professionals in Regulatory Affairs

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