Calls for reform in the assessment of orphan drugs in Germany, upon the implementation of EU Joint Evaluation.
OD (orphan drug) privilege status under the AMNOG procedure means that ODs are currently exempt from providing comparative data for their assessment. They are assumed to have a positive added benefit (with the lowest rating possible being a positive but unquantifiable added benefit), even when the data is insufficient to support this. If sales over 12 months surpass the €30 million mark, this privilege is revoked, and a full assessment is performed based on comparative data.
Written by Andrea Bernardini, Associate Consultant & Marco Sancandi, Analyst Contacts: abernardini@partners4access; msancandi@partners4access In a significant step forward for healthcare in Italy, the National Rare
Written by: James Lee, Analyst Contact: [email protected] China, with 1.4 billion people, holds promise as a market for pharmaceutical companies due to its major overhaul of
Accelerated approval and accelerated withdrawal – will the new clinical trial guidance bring US closer to Europe?
Written by: Srishti Gupta, PhD; Senior Consultant Contact: [email protected] In March 2023, the Food and Drug Administration (FDA) published, a first of its kind, draft
Orphan Drug market, how is Italy doing? The latest OSSFOR Booklet paints a favourable picture for the Italian landscape.
By Marco Sancandi, PhD; Analyst On the 31st of January 2023, the 6th joint report from the Orphan Drugs Observatory and the Italian Society of
By Fisentzos Stylianou, PhD; Senior Analyst The UK will be the first country to introduce a regulatory framework for innovative medicines manufactured at the point
Official countdown for the implementation of the Joint European Health Technology Assessment (EUnetHTA) begins!
Written by Priyanka Kiritharan, Analyst Contact: [email protected] Taking effect from January 2025, all advanced therapeutic medicines (ATMPs) and oncology drugs will be mandated to undergo
By Fisentzos Stylianou, PhD; Senior Analyst Contact: [email protected] “I can say on behalf of the G-BA that it is possible that we will recognise some