Federal Agency for Medicines and Health Products (FAMHP)
DG PRE authorisation National Innovation Office Eurostation II
Place Victor Hortaplein 40/40 1060 BRUSSELS
www.famhp.be/en/innovationoffice
Responsible publisher: Xavier De Cuyper
© famhp 2017 - Concept: Communication Division
The National Innovation Office of the FAMHP Facilitating and supporting research and development Your medicines and
health products, our concern
Project info meetings give innovators high level guidance on general regulatory requirements and procedural steps to follow when considering initiating a medicine development project and help identify any future scientific, technical and regulatory hurdles that may impact the project.
Project info meetings create awareness about
particular uncertainties or the feasibility of the project which can facilitate further project planning, thereby increasing the chances for success. If needed the applicants will be advised to request a formal national and/or European scientific advice.
Participation in the European Innovation Network (EU-IN)
Since 2015 the FAMHP participates actively in the European Innovation Network established by the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European National Competent Authorities (NCAs) to support medical innovation and early development of new medicines in the European Union.
The FAMHP’s National Innovation Office functions as a local hub or interface with the European Innovation Offices Network for any issues or queries from local innovators which may need further support and guidance at the European level.
In addition, EMA or the European Innovation Network may refer innovators already active at the European level for specific issues or queries to the local National Innovation Office of a specific NCA when needed.
www.famhp.be/en/innovationoffice
www.afmps.be/fr/innovationoffice
www.fagg.be/nl/innovationoffice
• Role
The National Innovation Office of the Federal Agency for Medicines and Health Products (FAMHP) has been launched in order to facilitate and support innovation in pharmaceutical research and development (R&D) in Belgium and the communication with the innovators.
The National Innovation Office is intended to serve as the central access point to the existing scientific and regulatory expertise of FAMHP both for human and veterinary medicines and therapies.
The National Innovation Office is accessible for pharmaceutical companies, small and medium-sized enterprises (SMEs), academic research centres, spin-offs, academic hospitals and individuals who are actively involved in pharmaceutical innovation in general and particularly in research and development of new medicines and therapies.
Moreover, the National Innovation Office offers tailor-made support mechanisms particularly to SMEs, academic research centres, spin-offs and academic hospitals.
Key services
Innovation-related FAMHP services and expertise
The FAMHP’s National Innovation Office provides detailed information on its webpage (www.famhp.
be/en/innovationoffice) on an ongoing basis about its different key services to support innovation and on how to request a meeting with the agency and its experts. You can find useful information that is relevant to innovators, in particular to SMEs, academic research centres, spin-offs and academic hospitals.
The National Innovation Office provides an online enquiry form that allows submitting queries to the FAMHP related to the development and putting on the market of innovative medicines and therapies. Queries can also be sent by e-mail to
innovationoffice@fagg-afmps.be.
The questions from innovators will be handled directly by the National Innovation Office or forwarded to the concerned FAMHP experts for further follow-up.
Scientific, technical and regulatory advice
The National Innovation Office of the FAMHP offers the possibility to request national scientific, technical and regulatory advice (STA) related to the research and development aspects of human or veterinary medicines in view of future clinical trial applications, marketing authorisation applications, introduction of variations to marketed medicines or line extensions.This centralised and transparent service within the FAMHP ensures the processing of the national STA requests in a timely fashion while assuring full confidentiality and avoiding potential conflict of interest of the involved experts.
For SMEs, academic research centres, spin-offs and academic hospitals, the National Innovation Office foresees specific presubmission STA assistance to guide the innovators during the preparatory phase of an STA application.
Workshops and events
The National Innovation Office organises workshops and participates actively in external life science events and symposia. In this way the FAMHP promotes greater regulatory awareness and scientific knowledge among innovators and increases awareness about the existence and potential benefit of using specific services of the FAMHP in support of (pre)clinical R&D activities.
Portfolio meetings
Portfolio meetings are high-level, informative meetings that allow applicants to present their company, the different company activities, the medicine development pipelines, the therapeutic areas in which they are actively involved or intend to explore, the latest scientific developments and challenges.
Portfolio meetings create the unique possibility for innovators to engage in an early dialogue with the FAMHP and allow an informal discussion on the potential critical issues related to R&D aspects of new innovative medicines and therapies, prior to potentially engaging in formal procedures such as scientific advice.
Project info meetings
For SMEs, academic research centres, spin-offs and academic hospitals, the National Innovation Office foresees the possibility to present a specific clinical research project situated in a very early stage of development.
