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Innovation. Scientific and regulatory support

Advances in science and technology applied to the development of medicinal products pose new challenges to the regulatory environment and new approaches are necessary to tackle them.

The ultimate goal is to ensure that patients have a timely access to innovation, in the frame of AIFA's remit to promote public health through safe and effective medicinal products.

In this context, AIFA created the Innovation & EMA Scientific Advice Office (Ufficio Innovazione e Scientific Advice EMA), hereafter Innovation Office. Its aim is to promote an early dialogue with public and private innovators engaged in the development of new products, advanced therapies, borderline products, nanotechnology-based medicines as well as new methodologies and technologies.

The objective is to provide scientific and regulatory support to fulfill the requirements needed for a successful development.

Moreover, being part of the European network of the Innovation Offices of all Member States, i.e. the EU-Innovation Network (EU-IN), AIFA's Innovation Office represents a discussion platform connecting national academic and research entities with European regulatory institutions, fostering the access to scientific and regulatory expertise offered by the European scenario and, at the same time ensuring a timely detection of emergent innovation including a rapid framing of its regulatory needs.

The EU-IN, by sharing information on emerging innovative technologies and products, allows the discussion of case-studies with the Innovation Offices of other member states and with EMA (upon developer's agreement), aiming to identify any gaps in the current regulatory framework which could hinder the journey of innovative products and methodologies. The EU-IN thus contributes to consolidate a shared scientific-regulatory position in relation to specific expertise areas and to identify training needs in support of the EU Network Training Centre (EU-NTC).

In this context, the objectives of AIFA's Innovation Office are:

  • Provide informal discussion and guide to developers of innovative products on AIFA's or EMA's more formal activities supporting innovation in its journey from early development up to the market entry
  • Make a proactive survey of the innovation developed at national level in the field of research and development of new medicinal products. 

It is possible to apply for an Innovation Meeting, an informal meeting where an innovative product, methodology or technology may be presented in order to receive guidance on the development program. 

Who may apply for an Innovation Meeting:Pharmaceutical Industries

  • Small and medium-sized enterprises (SMEs)
  • Academic institutions
  • Research entities

Contacts: innovation.office@aifa.gov.it

Data aggiornamento: November 2017
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