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Mensaje de: ECS1 Hora: 03/07/2026 16:40:40
De nada, y más comparado con tus aportaciones, siempre de valor añadido.
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huele a otro trámite burocrático importante y con posible impacto en precios de reembolso. Con el historial de PHM con reguladores, tiemblo.....
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Mensaje de: ECS1 Hora: 03/07/2026 16:40:40
The JCA reports are carried out by assessors and co-assessors on behalf of the EU’s Coordination Group on Health Technology Assessment, which is made up of member states’ representatives, mainly from HTA authorities.
The JCA assessment process runs in parallel with the European Medicines Agency’s process for reviewing marketing authorization applications (MAAs). Companies should submit relevant information for the JCA to the European Commission’s HTA Secretariat at the same time that they submit their MAAs to the EMA.
The JCA assessment process runs in parallel with the European Medicines Agency’s process for reviewing marketing authorization applications (MAAs). Companies should submit relevant information for the JCA to the European Commission’s HTA Secretariat at the same time that they submit their MAAs to the EMA.
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Mensaje de: ECS1 Hora: 03/07/2026 16:40:40
Joint Clinical Assessments
Joint clinical assessments (JCAs) are likely to be game changing for the way pricing and reimbursement is decided by EU member states and for the way that drug companies prepare for market access. They are similar to relative efficacy assessments carried out by member states health technology assessment (HTA) bodies and must be given “due consideration” by national HTA bodies in their assessments .
JCAs came into effect under the HTA Regulation in January 2025 for advanced medicinal therapy products (ATMPs), many of which are for rare diseases, and oncology products. JCAs will be applicable to all other types of medicines with EU orphan drug status from January 2028 and to all other drugs that are centrally authorized in the EU from 2030.
Joint clinical assessments (JCAs) are likely to be game changing for the way pricing and reimbursement is decided by EU member states and for the way that drug companies prepare for market access. They are similar to relative efficacy assessments carried out by member states health technology assessment (HTA) bodies and must be given “due consideration” by national HTA bodies in their assessments .
JCAs came into effect under the HTA Regulation in January 2025 for advanced medicinal therapy products (ATMPs), many of which are for rare diseases, and oncology products. JCAs will be applicable to all other types of medicines with EU orphan drug status from January 2028 and to all other drugs that are centrally authorized in the EU from 2030.
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Mensaje de: ECS1 Hora: 03/07/2026 16:40:40
Key Takeaways
PharmaMar has raised concerns about the joint clinical assessment process under the EU Health Technology Assessment Regulation.
It says that orphan drugs like Zepzelca cannot be assessed in the same way as non-orphan products.
PharmaMar also commented that the JCA was demanding and little of its feedback to the points raised through the process was incorporated into the final assessment.
PharmaMar has raised concerns about the joint clinical assessment process under the EU Health Technology Assessment Regulation.
It says that orphan drugs like Zepzelca cannot be assessed in the same way as non-orphan products.
PharmaMar also commented that the JCA was demanding and little of its feedback to the points raised through the process was incorporated into the final assessment.
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La acumulación de fallos, problemas "malas-suertes", encontronazos con reguladores y otros sin consecuencias para directivos de la empresa llama la atención: en cualquier empresa noraml hubieran rodado cabezas en varios niveles de la estructura organizativa. En PHM, que se sepa: " ami plin, yo duermo en pikolín"...
(3)
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Mensaje de: Pital Hora: 03/07/2026 8:19:37
No hay ego ninguno Gay el fundador y nuckeo de una empresa inno adora que acerto usando la evolucion..........
No hay ego ninguno Gay el fundador y nuckeo de una empresa inno adora que acerto usando la evolucion..........
hay mucho aficionadoque no sabe a lo que juega y cuando las cosas no salen como quieren descargan su frustración en los que están en el foro y si saben dónde están, lo asumen y además comparten su conocimiento (que no se obtiene leyendo el Marca) con los demás....
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Mensaje de: Marcos_55 Hora: 01/07/2026 16:43:04
Y tambien una cosa esta clara que a 24€ institucionales metieron 300k, probablemente algunos busca..........
Y tambien una cosa esta clara que a 24€ institucionales metieron 300k, probablemente algunos busca..........
¿cómo "se meten 300 mill" en accs. de Solaria para beneficiarse de una bajada? Explícalo pq no lo entiendo.....
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Mensaje de: Acopa Hora: 17/06/2026 10:20:20
A LP será un empresote… los que han comprado en 24€ lo saben
A LP será un empresote… los que han comprado en 24€ lo saben
Pues tengo la sensación de que buena parte d elas ventas que está habiendo es de esos que compraron a 24...
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Mensaje de: JOSÉ ANTONIO T.H. Hora: 26/05/2026 9:46:57
El trabajo sucio hecho prontito por la mañana??? Sería bien asunto
El trabajo sucio hecho prontito por la mañana??? Sería bien asunto
si, ahoran vendrán los buenos del thriller
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