Freyr Regulatory Radio

Episode 5. Global & the European Facilitated Regulatory Pathways

Time-to-market plays a major role in addressing the needs of vulnerable patient groups. Facilitated pathways across the globe accelerate the timelines of innovative drug molecules, allowing fast-tracked approval pathways for essential medicines. Our experts address the necessary requirements of innovators and elaborate on the facilitated Regulatory pathways. Reference Links * Centre for Innovation in Regulatory Science report New drug approvals in six major authorities 2011-2020 [https://cirsci.org/wp-content/uploads/dlm_uploads/2021/06/CIRS-RD-Briefing-81-6-agencies-v5.pdf]

Episode 4. Monitoring Medicines and Supervisory Committees

Grant of marketing authorizations signals the commencement of the years-long journey of a drug molecule. Post-market authorization activities begin once the molecule has been approved and is fit to use for the patient population. Inspection of a given drug product is of prime importance to keep patient safety at the very core. Our experts express their views regarding monitoring medicines and the supervisory committee within the EMRN.

Episode 3. Drug Development Lifecycle & Pathways

Drug development takes decades of planning and experimentation. Different phases of the drug development lifecycle come with their own unique challenges. Phase-by-phase development of a drug molecule ensures that safe and effective medicines enter the patient population. Our experts talk about the phases of the drug development lifecycle from the very initial phase to the end, with a view of simplifying the complex stages of drug development.

Episode 2. Centralised and Decentralised Procedures

Different approval pathways can be explored while entering the European pharmaceutical market. The approval pathways include: * Centralized Procedure (CP) * Decentralized Procedure (DCP) * National Procedure (NP) * Mutual Recognition Procedure (MRP) Our experts discuss the most explored pathways, CP and DCP, and the eligibility criteria to pursue them for product approval and marketing authorization within the European Union (EU).  Reference Links * EMA overview of the centralised authorisation procedure [https://www.ema.europa.eu/en/documents/presentation/presentation-centralised-procedure-european-medicines-agency_en.pdf] * European Commission summary of national authorization procedures [https://ec.europa.eu/health/medicinal-products/legal-framework-governing-medicinal-products-human-use-eu/authorisation-procedures-national-authorisation-procedures_en] * CMDh guidance on marketing authorization applications [https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for-ma.html]

Episode 1. The European Medicines Regulatory Network

Introduction to the European Medicines Regulatory Network (EMRN) across various functions and procedures. Our experts give an overview of different approval pathways and their significance and elaborate on the different networks available within EMRN for drug approvals.