The DG PRE-Authorisation of the Federal Agency for Medicines and Healthcare Products (FAMHP) offers applicants the possibility to request national scientific and/or technical (eg. regulatory) advice (STA) related to the research and development of human or veterinary drug products in view of potential clinical trial applications (CTA), marketing authorization applications (MAA) or introduction of variations to marketed drug products. The FAMHP’s main objective in providing STA to applicants at a national level is to promote and facilitate as much as possible the development of new drug products from a regulatory perspective in order to enhance the availability of innovative drug products to patients.
For this purpose the FAMHP has implemented a new, centralized and transparent service within the agency which should ensure the processing of national STA requests in a timely fashion while assuring full confidentiality and avoiding potential conflict of interest of the involved experts. The FAMHP also aims to provide a consistent follow-up of previous national and European advices (eg. through its interface with the SAWP at EMEA) in order to assure the quality and consistency of the national STA’s issued by the FAMHP.
The Royal Decree of 31.03.2009 in execution of Article 6sexies of the Belgian Medicines law of 25.03.1964 which was published in the “Moniteur belge” on 14.04.2009, defines the conditions, timelines and rules of procedure for requests for national STA.
Detailed information can be found on the page “Scientific-Technical advice” under the section “Research & Development”