Introduction

The DG PRE-Authorisation of the Federal Agency for Medicines and Healthcare Products (FAMHP) in Belgium offers applicants the possibility to request national scientific and/or technical (eg. regulatory) advice (STA) related to the research and development aspects of human or veterinary drug products in view of potential clinical trial applications (CTA’s), marketing authorisation applications (MAA’s), introduction of variations to marketed drug products or line extensions. 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, especially in therapeutics areas where an unmet medical need exists.

For this purpose the scientific-technical advice unit of the DG PRE-Authorisation offers a 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 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 and SAWP-V at the EMA) in order to assure the quality and consistency of the national STA’s issued by the FAMHP. 

The Royal Decree of July 16th 2012 implements the modification of the definitions, procedures and fees that are applicable to requests for national scientific-technical (eg. regulatory) advice (STA) which are being treated by the unit for STA within the Directorate-General (DG) PRE-Authorisation of the FAMHP.

The RD of July 16th 2012 modifying the Royal Decree of March 31st 2009 in execution of Article 6sexies of the Belgian Medicines law of March 25th 1964, was published in the “Moniteur Belge” on October 8th 2012 and entered into force on October 18th 2012.

Any general or specific questions that applicants may have related to the national scientific and/or technical (regulatory) advice service of the FAMHP can be sent to the following mailbox: sta@fagg-afmps.be

However applicants are kindly being requested to consult the “Detailed guidance for National Scientific-Technical Advice (STA) requests” before sending questions to the mailbox mentioned above.

Last updated on 18/07/2017