What is Scientific Advice?
Scientific Advice (SA) can be defined as a service offered by Regulatory Authorities, in the broad sense of the term advising on issues related to the development of medicinal products. This type of 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, and addresses the issues raised by the Applicant in the request form. 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
- Medicinal product supply category
- Pharmacovigilance and risk management.
Some of the national Authorities also offer advice on regulatory (administrative) matters. However, it should be emphasized 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) can take advantage of Scientific Advice and have the opportunity through SA to have an open dialogue and obtain reliable information during discussions with the Experts.
What to consider when planning Scientific Advice?
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 a response from the Authority can vary from several weeks to several months.
The format of the response of the Authority can depend on both the Agency’s requirements and the Applicant’s preference – SA can take place in the form of online meetings, as well as face-to-face or be performed in writing form. Regardless of the format, 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.
Of course, the details of what such advice looks like depend on the Agency to which you request it.
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.
It is also worth bearing in mind that the advice given in the SA is not binding on either the Agency or the Applicant and should not be viewed as the official position of the Agency.
What experience do we have in preparing Scientific Advice applications?
Our Experts have extensive experience in preparing, reviewing and submitting SA applications to both national Agencies in the EU (e.g. Hungary, Ireland, Spain, Finland), and also outside the EU (Canada) as well as to the EMA (for centrally registered products).
What distinguishes us from our competitors when it comes to the “Scientific Advice” service?
In addition to the preparation and submission of the Scientific Advice application, SciencePharma also offers support in the preparation of the registration dossier for all Modules and substantive problems solving.
Keeping abreast of the latest Competent Authorities requirements is much easier with the support of an experienced and well-informed team.
At SciencePharma, we offer both the preparation and submission of an application for scientific advice to the Competent Authorities, as well as complex registration/post-registration services for medicinal products – depending on the individual needs of the Marketing Authorisation Holder.
If you are interested in working with us, please do not hesitate to contact us.
Our Experts will answer all your questions and resolve doubts.