Scientific advices
Scientific-technical advice
1. Introduction
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’s), marketing authorization applications (MAA’s) 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 (French version)
in execution of Article 6sexies of the Belgian Medicines law of 25-03-1964 (French version) which was published in the “Moniteur belge” on 14-04-2009, defines the conditions, timelines and rules of procedure for requests for national STA.
2. How to apply for national STA
- Any official request for national STA falling within the legal scope of a complex advice (FULL STA) or ad hoc advice (AD HOC STA) should be submitted to the Directorate-General PRE-authorisation of the FAMHP. These requests should be sent electronically to our central mailbox: sta@fagg-afmps.be
Alternatively, eg. in case large electronic files above 5 MB would be submitted, electronic STA requests can also be sent on CD-rom or USB key.
In addition, applicants are asked to send at least two hard copies of the national STA request by post to the following address :
Federal Agency for Medicines and Health Products
Directorate-General PRE-authorisation (desk 8D222)
Victor Hortaplein 40/40
B-1060 Brussels
BELGIUM
To the attention of Ms. Greet Musch
- Each STA request must contain sufficient supportive documentation and a completed electronic application form in order to ensure an effective and efficient handling of the advice requests throughout the procedure and to allow the FAMHP to provide a pointed advice of sufficient quality. Detailed information regarding the supportive documentation to be included in a STA request can be found in annex below:
Applicants can download the electronic application form (access format) mentioned below and should (1) include the completed electronic document in the STA request that will be submitted electronically and (2) include a paper copy in the STA dossiers that should be sent by post to the FAMHP.
“Electronic application form” (ZIP, 670.25 Kb)
- Each STA request must be accompanied by payment of the appropriate fee: Each complex advice request (FULL STA) requires payment of 2105,91 € and each ad hoc advice request (AD HOC STA) requires payment of 210,59 € regardless if the request concerns an initial or follow-up STA request. Payment must be made on the following bank account nr. of the FAMHP:679-0021942-20
Contact details of the bank:
Poste financière
Chaussée d'Anvers 59
B-1100, Bruxelles (Belgium)
IBAN : BE28 6790 0219 4220
BIC : PCHQBEBB
Applicants should clearly mention on the bank statement if the application concerns a complex (FULL STA) or ad hoc advice request (AD HOC STA) and if it concerns an initial or follow-up STA request; followed by the name of the applicant.
For payments from abroad the transfer fees should be paid by the payer. Applicants are also requested to include a proof of payment (eg. a bank statement) to the STA request since this is verified during the validation of the STA request.
3. Procedures
All submitted FULL and AD HOC STA requests are subjected to a validation step in order to verify compliance with the dossier requirements outlined in paragraph 2.
FULL STA requests will be addressed by the FAMHP in a face-to-face meeting or through a teleconference meeting with the applicant within 70 days after validation. Applicants are requested to draft up the meeting minutes and send them back to the FAMHP within 14 days after the meeting. The FAMHP will send back the validated meeting minutes to the applicant within 14 days after receiving the draft minutes.
AD HOC STA requests will be addressed by the FAMHP in writing, within 30 days after validation.
Further detailed information regarding the definition of a FULL /AD HOC advice request, legal scope, procedures, timelines, etc. can be found in annex below:
“Detailed guidance for National Scientific-Technical Advice (STA) requests” (PDF, 165.85 Kb)
After the final STA advice has been given, the applicant will receive a feedback questionnaire which can be filled in on a voluntary basis and which can be sent back to the FAMHP. The questionnaire is intended to obtain the applicant’s opinion on the quality aspects of the received national STA service.
“FAMHP questionnaire on national scientific technical advice (STA)” (DOC, 396 Kb)
4. Fees
At current, the following fees apply to requests for national STA submitted to the FAMHP:
- Complex advice (FULL STA): 2033,64€
- Ad Hoc advice (AD HOC STA): 203,36€
The same fees for national STA request will apply independently of the type of applicant by whom the STA request is submitted to the FAMHP: sponsors of clinical trials, pharmaceutical/biotech companies (eg. small biotech spin offs, SME’s, global companies), research centres, etc.
The same fees for national STA request will apply regardless of the area of advice (eg. paediatrics, oncology, etc..) or timing of seeking advice at national level (eg. initial versus follow-up advice).
5. Questions
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 mailbox mentioned above.