Office for support of Innovation and knowledge of medicinal products

Last update: 3 February 2017

The Spanish Agency of Medicines and Medical Devices has launched the Spanish office for support of innovation and knowledge of medicinal products in order to integrate coordinate and strengthen the different activities and initiatives supporting investigation, innovation and the obtaining of additional knowledge about new medicinal products performed by the Agency in Spain and within the Framework of the European Medicines Agencies Network.

The office for support of innovation and knowledge of medicinal products of the AEMPS has been created with an integrated vision of the life cycle of medicinal products. Access to medicinal products is considered from a global perspective that covers the promotion and support of investigation and development of new therapeutic alternatives which respond to the real needs of the society, the optimisation of access to these alternatives by patients according to their moment of development and available evidence as well as the promotion and support of research that improves the knowledge of already authorised medicinal products.

The services offered by the office for support of innovation and knowledge of medicinal products include integration into the European Innovation Task Force, on-going support for research and knowledge building on the existing degree of data of the same product, as well as, guaranteed access to medicinal products in all its aspects.

Services offered by office for support of innovation and knowledge of medicinal products

  • Integration of national activities in the European Network activities and European procedures

    Objetive: Coordination with the European Network of Innovation Offices.

    Addressees: Academic groups, independent investigators, cooperative groups, hospitals, research foundations, start-ups, small and medium-sized companies.

    Usefulness: Identification of innovative projects, information on the available regulatory tools for each specific project and integration in the European system of authorisation of medicinal products or other support tools at a national level.

    Information and contact:

    E-mail: innov_spain@aemps.es

  • Independent clinical investigation Support Office

    Objetive: Support in investigation.

    Addressees: Academic groups, independent investigators, cooperative groups, hospitals, research foundations, start-ups.

    Usefulness: Regulatory and scientific support in the process of authorisation or classification of clinical trials with any type of medicinal product.

    Information and contact:

    Website: Office for support of innovation and knowledge of medicinal products

  • Support in the development of Advanced Therapy Medicinal Products

    Objetive: Support in investigation.

    Addressees: Academic groups, independent investigators, cooperative groups, hospitals, research foundations, start-ups, small and medium-sized companies, pharmaceutical industry in general.

    Usefulness: Identification and classification of innovative projects related to advanced therapies, regulatory and scientific support in these developments.

    Information and contact:

    Website: Form for advice request on advance therapy medicines

  • National Scientific Advice and in the EMA Scientific Advice Working Party

    Objetive: Support in investigation.

    Addressees: Academic groups*, independent investigators*, cooperative groups*, hospitals*, research foundations*, start-ups, small and medium-sized companies, pharmaceutical industry in general.

    Usefulness: Scientific support of the Health Authorities in the investigation of medicinal products in their different phases of development.

    Information and contact:

    Website: Technical consulting

    E-mail: ascina@aemps.es

    Regulatory advice

    Objetive: regulatory support.

    Addressees: Academic groups*, independent investigators*, cooperative groups*, hospitals*, research foundations*, start-ups, small and medium-sized companies, pharmaceutical industry in general.

    Usefulness: Regulatory support of the Healthcare Authorities in the investigation of medicinal products in their different phases of development. Resolution of consultations regarding the application of the current legislation and regulatory strategy.

    Information and contact:

    Website: Technical consulting

    E-mail: ascina@aemps.es

  • Parallel scientific advice with EMA /HTA

    Objective: Support in investigation/ regulatory / access.

    Addressees: Academic groups*, independent investigators*, cooperative groups*, hospitals*, research foundations*, start-ups, small and medium-sized companies, pharmaceutical industry in general.

    Usefulness: Optimisation of the development of medicinal products by the early incorporation of aspects and considerations related to subsequent assessment of health technologies.

    Information and contact:

    E-mail: advice_HTA@aemps.es

  • Clinical trials with medicinal products

    Objective: Access to medicinal products prior to their authorization.

    Addressees: Patients and patient associations, healthcare professionals, managers of investigation.

    Usefulness: Obtaining information with regard to clinical investigations permitted in Spain through the Spanish clinical trials registry (REec).

    Information and contact:

    Website: Clinical research with medicines for human use

  • Compassionate use of investigational medicinal products

    Objective: Access to medicinal products prior to their authorization.

    Addressees: Patients and patient associations, healthcare professionals, healthcare centres.

    Usefulness: Access to treatments with medicinal products in the investigational phase in appropriate cases.

    Information and contact:

    E-mail: medicamentosespeciales@aemps.es

  • Therapeutic Positioning Reports

    Objective: Access to medicinal products after their authorisation

    Addressees: Healthcare authorities, patient associations, scientific societies, marketing authorisation holders of new medicinal products

    Usefulness: Determination of the therapeutic value of the new medicinal products compared to their alternatives in the market

    Information and contact:

    Website: Therapeutic Positioning Reports

    E-mail: gcpt@aemps.es

  • Recommendations for off label use

    Objective: Access to medicinal products after their authorization.

    Addressees: Healthcare professionals, healthcare centres, Autonomous Communities, patients.

    Usefulness: Preparations of recommendations for the use of medicinal products in conditions different from those established in their summary of product characteristics.

    Information and contact:

    Website: Software application for medicines in special situations

    E-mail: gcpt@aemps.es

* Scientific advice for investigators in the academic field, hospital units or non commercial bodies does not entail payment of fees.

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