Italian Medicines Agency Agenzia Italiana del Farmaco

Innovation and scientific advice

Innovation and scientific advice

Scientific and technological progress applied to the development of medicinal products poses new challenges to the regulators and new approaches are necessary to respond to new needs.

The ultimate goal is to guarantee patients timely access to technological innovations, in compliance with the regulatory tasks entrusted to AIFA for the protection of public health through medicinal products.

In this context, AIFA promotes early comparison and interaction with public or private actors engaged in the development of new methodologies and technologies applied to the development of pharmaceutical products, such as advanced therapies, borderline products, nanotechnologies, with the aim of providing scientific and regulatory support, with particular regard to the requirements necessary for successful development.

The Agency is also connected to the European network of the EU-Innovation Network (EU-IN), a platform for linking national academic and research realities and the European regulatory institutions, to facilitate access to the regulatory and scientific tools that the European scenario can offer and to ensure the identification of new technologies and their timely classification in the regulatory framework.

The EU-IN, through the sharing of information on emerging innovative products and technologies, allows the discussion of individual cases with the Innovation Offices of the other Member States and with the EMA (with the consent of those who developed the product),in order to identify any deficiencies in the current regulatory framework that could hinder the development. The EU-IN thus contributes to the consolidation of a shared scientific-regulatory position in relation to particular areas of competence and to the identification of training needs of the network in support of the EU Network Training Centre (EU-NTC).

In this context, the objectives of AIFA are:

  • informally inform and guide the developers of innovative products towards the activities that AIFA or EMA use to support innovation during its development path up to market entry
  • carry out a proactive survey on the level of innovation in the field of research and development of new medicinal products in the national territory.

It is possible to request an Innovation Meeting, an informal meeting during which it is possible to present an innovative product, technology or methodology in order to receive feedback or guidance on the evolution of the development programme.

 

Who can request an Innovation Meeting

  • Pharmaceutical industries
  • Small and medium-sized enterprises
  • Universities and Academic Institutions
  • Research Institutions

 

Reference offices

Innovation & EMA Scientific Advice Office

Paolo Foggi (ad interim)

p.foggi@aifa.gov.it

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