Streamlining Post-Authorization Changes: Key Updates to the EU Pharmaceutical Variation Guidelines As part of the 2020 Pharmaceutical Strategy for Europe, the Commission is reviewing the current rules governing the procedures for post-authorization changes to the terms of a marketing authorization for medicines products for human use, with the purpose to make the lifecycle

AN ASSESMENT OF THE EU PARLIAMENT AMENDMENTS TO THE COMMISSION PROPOSAL OF THE EU PHARMA PACKAGE The European Parliament recently published its amendments to the draft text on the Commission's proposal for updating the EU pharmaceutical legislation. This blog covers the significant updates, including regulatory data protection, managing supply shortages, environmental impact

Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products: FDA Guidance Explained Introduction In the realm of nonprescription drug products, even minor labeling changes require careful consideration and documentation to ensure regulatory compliance and consumer safety. The Food and Drug Administration (FDA) has released comprehensive guidance to assist applicants of approved new

All EU Clinical Trials to be Transitioned to the New CTIS Portal by January 2025 - Don’t Wait, Act Now! Since January 2022, the new Clinical Trial Regulation (CTR) has been in force, which replaced the Clinical Trial Directive (CTD). With the CTR, also a new online portal for clinical trials, the

EMA Update on On-site GMP and GDP Inspections Approach for 2024 The latest news on the approach in 2024 by the GMP/GDP Inspectors Working Group is that the validity of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) certificates has been extended until 2024 or until the completion of the next

An Inside Look: The European Commission Publishes the First Union List of Critical Medicines Shortages of medicinal products are an increasing problem in the EU, therefore, one of the objectives of the new proposed European pharma REFORM is to enhance the security of supply and ensure medicines are available to patients in

FDA Proposes Benefit-Risk Assessment Guidance for New Drug and Biological Products In October 2023, the FDA introduced a significant guidance document, “Benefit-risk assessment for new drug and biological products”, for the pharmaceutical industry. This guidance focuses on the assessment of benefit-risk for new drugs and biological products. This comprehensive guideline aims to

FDA Issues Guidance for Industry on Biosimilar Labeling Stay Informed, Stay Prepared The FDA is charting the course for the future of biosimilars with its recent release. On September 15, 2023, the FDA unveiled its draft guidance document, "Labeling for Biosimilar and Interchangeable Biosimilar Products," along with a Notice of Availability (NOA).

FDA Finalizes Guidelines on Dose Banding for Ready-to-Use Containers The U.S. Food and Drug Administration (FDA) has recently issued a new guideline titled "Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” Guidance for Industry” and was recently