title: Contribution of the spanish agency for medicines and healthcare products to the European committee for the evaluation of medicinal products for human use.
abstract: The centralized procedure for registering medicinal products involves a joint assessment by all regulatory agencies of European Union member states, which are coordinated by the European Medicines Agency. Since its implementation in 1995, the Spanish Agency for Medicines and Healthcare Products (AEMPS) has actively contributed to the committee on medicinal products for human use. The therapeutic areas in which AEMPS has the greatest presence are cardiovascular, sensory organs (mainly ophthalmology) and genitourinary/sexual hormones. The technical staff of AEMPS contributes their expertise and extensive experience to this task, as do the practitioners of the Spanish healthcare system who act as external experts, providing their clinical vision and bringing the daily clinical practice to the evaluation of medicinal products. As with other European decision spaces, the joint participation of the member states is not homogeneous, with a minority of countries still heading the majority of assessments for the committee on medicinal products for human use, although all member countries take part in the final decision.
authors: Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, España. Electronic address: aalonsog.ana@gmail.com.
authors: A
authors: A
authors: Alonso-Gutiérrez
authors: Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, España.
authors: P
authors: P
authors: Díaz-Ramos
authors: Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, España.
authors: E
authors: E
authors: Sulleiro-Avendaño
authors: Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, España.
authors: M
authors: M
authors: de Miguel-Marañón
authors: Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, España.
authors: M E
authors: ME
authors: Padilla-Gallego
authors: Instituto de Investigación Sanitaria Puerta de Hierro, Madrid, España; Miembro del Comité de Medicamentos de Uso Humano, Agencia Europea del Medicamento, Londres, Reino Unido.
authors: A
authors: A
authors: Sancho-López
authors: Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, España; Miembro del Comité de Medicamentos de Uso Humano, Agencia Europea del Medicamento, Londres, Reino Unido.
authors: S
authors: S
authors: Ruiz-Antúnez
authors: Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, España; Miembro del Comité de Medicamentos de Uso Humano, Agencia Europea del Medicamento, Londres, Reino Unido.
authors: C
authors: C
authors: Prieto-Yerro
keywords: AEMPS; CHMP; Centralized procedure; EMA; Medicamentos de uso humano; Medicinal products for human use; Procedimiento centralizado