Simultaneous National Scientific Advice for Timely Multi-Regulatory Authority Feedback
Scientific advice is a regulatory process expected to, “facilitate timely access to safe and efficacious medicinal products to patients and users of medicines by optimizing research and development, reducing uncertainties about regulatory outcomes, and accelerating time to approval of a marketing authorization application”. Applicants commonly seek advice centrally from the European Medicine’s Agency (EMA) or nationally from individual Member State (MS) Regulatory Authorities (RAs). Beginning in February 2020, the EU-Innovation Network (EU-IN) of the Head of Medicines Agencies (HMA) initiated a pilot program for Simultaneous National Scientific Advice (SNSA) as an additional opportunity for RA engagement. This white paper addresses why it is important for developers to understand the SNSA process and when it should be considered as part of a broader drug development strategy.
Basics of Regulatory Strategy
Driving development of drug products from pre-IND through marketing.
Regulatory Operations: An Evolution Aligned with Changing Industry Needs
One of the most persistent challenges for companies when it comes to regulatory operations is balancing the right level of support with the right…
Chemistry, Manufacturing, and Controls (CMC) in Drug Development and Life Cycle Management
This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development.…