Regulatory Blog

The U.S. Food and Drug Administration (FDA) has issued guidance documents to help pharmaceutical manufacturers understand regulatory expectations related to market exclusivity for drug products  and responses to inspection findings following CGMP inspections . These guidances support transparency in regulatory processes and help industry ensure compliance with quality and development requirements. Guidance: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug

This blog summarizes two important regulatory guidances from the U.S. Food and Drug Administration (FDA) that support pharmacovigilance and real-world evidence generation: M14: General Principles for Planning, Designing, Analyzing, and Reporting Non-Interventional Studies E2D(R1): Post-approval Safety Data – Definitions and Standards for Management and Reporting of Individual Case Safety Reports Together, these guidances provide a framework for how pharmaceutical companies ge

The U.S. Food and Drug Administration (FDA) has issued a final rule titled “ Revising the National Drug Code Format and Drug Label Barcode Requirements .”  This rule introduces a uniform 12-digit National Drug Code (NDC) format  to standardize how drugs marketed in the United States are identified. The National Drug Code is an FDA standard used to uniquely identify drug products marketed in the U.S. Currently, the NDC assigned by FDA is a 10-digit number , and it may appear i

The Medicines and Healthcare products Regulatory Agency (MHRA) provides an online portal that enables organisations and individuals to submit regulatory forms and manage applications electronically. The MHRA Portal is designed to streamline regulatory submissions, improve efficiency, and provide a centralised system for interacting with the agency. This guidance explains how users can register for the MHRA Portal, outlines the registration process, and describes key considera

The Early Access to Medicines Scheme (EAMS)  is a regulatory initiative in the United Kingdom designed to provide patients with life-threatening or seriously debilitating conditions earlier access to promising medicines before full marketing authorisation is granted. The scheme is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) and aims to accelerate patient access to innovative treatments where there is a clear unmet medical need. The main obj