scientific advice
Scientific advice
Providing scientific advice is not only one of the statutory tasks of the MEB (see Medicines Act). By providing scientific advice, the MEB acontributes to the responsible development of medicines. For example, by discussing the proposed investigations and studies with the participants in a timely manner, seen from the context of an authorisation (application) in due course. The MEB maintains the standpoint that it does everything within its capabilities to honour the requests for advice.
What matters does the MEB provide scientific advice on?
There is the possibility of asking the MEB for advice during the development phase of a medicinal product. This also applies to medical devices with a supporting pharmaceutical substance. The request for advice to the MEB can occur during the (early) development phase, but also just prior to the actual submission of the authorisation application. The request for advice can be related to the scientific content of the dossier (chemical pharmaceutical, pharmacological toxicological, pharmacokinetics, clinical and/or pharmacovigilance) and/or the marketing authorisation procedure that must be followed. This includes providing scientific advice about the need for animal tests during the development phase of medicinal products.
These questions must be related to the future development of the product within the requested indication, or must be related to the marketing authorisation dossier (data package), the authorisation route that will be followed and the role that the MEB could play in the marketing authorisation phase.
The advice is given according to the current state of scientific knowledge and in accordance with the current guidelines, but cannot pre-empt the final judgement by the MEB and/or the CHMP following evaluation of the complete dossier. Of course, the MEB will treat all submitted data as strictly confidential.
Regulatory advice mainly concerns questions about the legal basis of an application. If desired, this can be provided together with a scientific advice, or separately.
See Regulatory Affairs > Products & Fees for an overview of the costs for scientific advice.
Joint advice from the Health Care Insurance Board and the MEB
As of 1 September 2012, it is possible to request scientific advice simultaneously from both the MEB (for the purpose of marketing authorisation) and the Health Care Insurance Board (CVZ, for the purpose of reimbursement) in one single procedure. This could be relevant for companies, for example when setting up a clinical study (phase 3), so that it can meet the guidelines for both marketing authorisation and reimbursement. Both organisations (MEB and CVZ) accept responsibility explicitly for their own part of the advice. The collaboration will be evaluated after one year.
Questions concerning the pharmaco-economic study cannot be posed to CVZ in this procedure. These questions should be submitted separately to CVZ.
If you wish to make use of this procedure, please use the standard application form for scientific advice and add the specific question (including applicant’s point of view) for the CVZ to this form. All further correspondence goes via the MEB.
Who can request scientific advice from the MEB?
All parties involved in the development of a medicine can submit a request for scientific and/or regulatory advice. In addition to pharmaceutical companies, (academic) research facilities involved in translational medicine research can also submit a request for advice. If you wish, you can contact the MEB first for further information via the contact details listed below.
Forms of scientific advice
For the scientific advice, you can select either a verbal meeting or a written advice only. Regulatory advice is usually only provided in writing. The verbal meeting is intended primarily to achieve effective exchange of (scientific) insights first – in an informal setting – and gives both the applicant and the experts at the MEB the chance to ask questions about or provide further information on specific aspects.
See: How do I submit a request for scientific advice?
Questions?
For general questions, you can contact the Scientific Programme Desk, telephone number: +31 (88) 224 8227
, E-mail: pb.wetenschap@cbg-meb.nl.
If you have questions about an application that has already been submitted, you can send an e-mail to case@cbg-meb.nl, referring to the case number.
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