Scientific and regulatory advice
Providing scientifc advice is not only one of the statutory tasks of the MEB. By providing scientific advice, the MEB also contributes to the responsible development of medicines. For example, by discussing the proposed research and studies with the applicants, seen from the context of an upcoming authorisation (application). 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 application for authorisation. 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 testing 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 procedure and the role that the MEB could play in the marketing authorisation phase.
The request for advice can also be related to herbal medicinal products. For example, the legal basis, the way in which European Union herbal monographs may play a role in the assessment, or the way in which 'traditional use' is assessed.
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. This can be provided together with a scientific advice, or separately.
Application form for MEB Scientific and/or Regulatory Advice
All parties involved in the development of a medicine can submit a request for scientific and/or regulatory advice. In addition ...
Scientific advice during the development of a medicinal product
Before a medicinal product can be authorised and brought onto the market, several steps must be followed. The Medicines ...