What is Scientific Advice?
Scientific Advice (SA) can be defined as a service in the broad sense of the term advising on issues related to the development of medicinal products offered by regulatory authorities. Scientific advice can be provided both at the national level (through individual national competent authorities) and at the European level (in this case scientific advice is provided by EMA (European Medicines Agency) experts.
The advice is provided in the light of current scientific knowledge, based on documentation provided by the Applicant. The topics that may be covered by SA are actually highly varied and may be different for each National Authority. Examples of areas that may fall within its scope are:
- Manufacturing and quality of medicinal products (chemical, pharmaceutical, biological development)
- Planning and implementation of non-clinical studies (e.g. pharmacological, toxicological studies)
- Planning and implementation of clinical studies
- Biostatistics, methodological issues
- Pharmacovigilance and risk management.
Some of the national Authorities also offer advice on regulatory matters. However, it should be emphasised that the purpose of Scientific Advice is not the pre-assessment of registration dossiers.
Who is the advice for?
Both large pharmaceutical companies and smaller drug developers (including academic institutions) have the opportunity through SA to have an open dialogue and obtain reliable information during discussions with the Experts.
What to consider when planning SA
It is possible to apply for SA both during an early stage of development of a medicinal product, before submission of a marketing authorization application, as well as after marketing authorization granting. However, it is a good practice to plan this in advance, as the waiting time for an appointment can vary from several weeks to several months.
Scientific Advice requires the submission of an application (often prepared on an appropriate form) to the relevant regulatory authority. It also involves the preparation of an adequate list of questions together with a justification of the Applicant’s position. Therefore, it is worth emphasising how crucial it is to state specific and precise questions with a comprehensive justification – only questions from the list prepared and presented in advance are taken into account during the procedure.
Obviously, the details of how such advice looks like depend on the Authority to which you are applying. The format of the meeting may depend on both the Agency’s requirements and the Applicant’s preference – SA may take the form of online meetings as well as face-to-face sessions or in writing. For face-to-face meetings, the Applicant should prepare a list of participants and their functions. Regardless of the form, there is usually a fee for this service – the cost depends on the Agency providing the advice and sometimes also on the scope of the advice. It is also worth bearing in mind that the advice given in SA is not legally binding for either the Authority or the Applicant and should not be seen as the official position of the competent authorities.