Evaluación y Regulación: interfaz y flujo de la I+D de las nuevas moléculas

Transcription

1 Evaluación y Regulación: interfaz y flujo de la I+D de las nuevas moléculas César Hernández García Jefe de Departamento Medicamentos de Uso Humano Agencia Española de Medicamentos y Productos Sanitarios

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3 Clinical Trials

4 CT Legislation Pharma Legislation Cross Border Directive (new proposal on HTA 2018) Transparency Directive Clinical Trials

5 CT Legislation Pharma Legislation Cross Border Directive (new proposal on HTA 2018) Transparency Directive Clinical Trials NCA Offices EU Innovation Network ITF Coordination and Support Action

6 CT Legislation Pharma Legislation Cross Border Directive (new proposal on HTA 2018) Transparency Directive Clinical Trials NCA Offices EU Innovation Network ITF Coordination and Support Action National SA Centralized SA Scientific Advice

7 CT Legislation Pharma Legislation Cross Border Directive (new proposal on HTA 2018) Transparency Directive Clinical Trials NCA Offices EU Innovation Network ITF Coordination and Support Action National SA Scientific Advice Centralized SA PRIME accelerate assessment EMA EPAR Conditional MA MA Exceptional Circumstances

8 CT Legislation Pharma Legislation Cross Border Directive (new proposal on HTA 2018) Transparency Directive Clinical Trials NCA Offices EU Innovation Network ITF Coordination and Support Action National SA Scientific Advice Centralized SA PRIME accelerate assessment EMA Parallel Consultation EUnetHTA EPAR Conditional MA MA Exceptional Circumstances EMA Committees Relative effectiveness assessment (REA)

9 CT Legislation Pharma Legislation Cross Border Directive (new proposal on HTA 2018) Transparency Directive Clinical Trials NCA Offices EU Innovation Network ITF Coordination and Support Action National SA Centralized SA PRIME Scientific Advice accelerate assessment Adaptive pathways Parallel Consultation EUnetHTA EPAR Conditional MA MA Exceptional Circumstances Relative effectiveness assessment (REA) Repurposing

10 CT Legislation Pharma Legislation Cross Border Directive (new proposal on HTA 2018) Transparency Directive Clinical Trials NCA Offices EU Innovation Network ITF Coordination and Support Action National SA Centralized SA PRIME Scientific Advice accelerate assessment Adaptive pathways Parallel Consultation EUnetHTA EPAR Conditional MA MA Exceptional Circumstances Relative effectiveness assessment (REA) Repurposing Registries Real World evidence

11 CT Legislation Pharma Legislation Standing Committee Cross Border Directive (new proposal on HTA 2018) Transparency Directive NCA Offices EU Innovation Network ITF Coordination and Support Action Ad hoc CT Expert Group CTFG National SA Centralized SA PRIME IMI projects Scientific Advice accelerate assessment EMA Clinical Trials Adaptive pathways Parallel Consultation EUnetHTA HMA and HMA Experts Groups (MAWP and 2020 Strategy) EPAR Conditional MA MA Exceptional Circumstances Safe and Timely Access to Medicines for Patients (STAMP) Expert Group Pharma Committee EMA Committees Relative effectiveness assessment (REA) Repurposing Registries Real World evidence

12 CT Legislation Pharma Legislation Standing Committee Cross Border Directive (new proposal on HTA 2018) Transparency Directive NCA Offices EU Innovation Network ITF Coordination and Support Action Ad hoc CT Expert Group CTFG National SA Centralized SA PRIME IMI projects Scientific Advice accelerate assessment EMA Synergy Group Clinical Trials EMA-EUnetHTA collaboration Adaptive pathways Parallel Consultation EUnetHTA HTA network HMA and HMA Experts Groups (MAWP and 2020 Strategy) EPAR Conditional MA MA Exceptional Circumstances Safe and Timely Access to Medicines for Patients (STAMP) Expert Group Pharma Committee EMA Committees Relative effectiveness assessment (REA) Repurposing Registries Real World evidence CAPR Network Project Euripid

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14 Doce minutos algunas (3) ideas (algunas contracorriente)

15 recolocar los incentivos

16 Desarrollar nuevas estrategias para el desarrollo de medicamentos sin caer en la ingenuidad (lo cual no debe ser fácil, pero para que nos vamos a quedar con lo fácil)

17 Finalmente, o trabajamos juntos o seguimos como hasta ahora

18 GRACIAS