The two EU-HTA procedures for the active substances catequentinib and Tacquell have been closed. The central issue is Article 9 of Regulation (EU) 2021/2282.
Article 9 requires an EU-HTA dossier to contain complete and current information, data, analyses and evidence so that the parameters defined in the JCA can be assessed. On top of that, the evidence submitted must be complete, analysed with suitable methods, presented transparently and remain verifiable through the underlying documentation.
The documents submitted for catequentinib and Tacquell show that these requirements are checked very strictly. Handing in a single clinical study or selected result tables is not enough. The EU-HTA dossier has to provide a complete assessment basis that is tied to the PICO question and that can be followed step by step in methodological terms.
You can find the detailed reasoning in the European Commission documents here: first document and second document.