Simultaneous national scientific advice
A few weeks ago the European Medicines Agency published Guidance on simultaneous national scientific advice (SNSA).
SNSA is intended for situations where an applicant wishes to obtain scientific advice from more than one national competent authority (NCA) at the same time. This is meant to enhance the quality and consistency of such advice.
Following endorsement by the Heads of Medicine Agencies (HMA), the second phase of the SNSA pilot will run for a two-year period until the end of 2024. Sixteen European countries take part in the second phase, the list of the countries is available on EMA website.
Developing, improving and consolidating the scientific advice procedure, Europe encourages the medicinal products manufacturers to seek advice.
The medicinal product development is a complex process, based on a number of regulations, standards and guidelines. Nevertheless, there are cases in which current legislation and available guides do not give the necessary answers.
Scientific advice may be requested at any stage of medicinal product development to help the manufacturer to find the right way from the early beginning.
It must be noted, that scientific advice is not legally binding and does not guarantee approval of the MAA in the future. But despite this, the possibility to get the competent authority opinion on your questions should not be neglected.
STARODUB team has sufficient expertise and experience to guide you through the scientific advice procedure to help you reach your goal. Please feel free to contact us via contact form.