Document Overview The Reflection Paper on a Tailored Clinical Approach in Biosimilar Development (EMA/CHMP/BMWP/60916/2025), published by the European Medicines Agency (EMA) on March 17, 2025, explores the potential to streamline clinical requirements for biosimilar approval by emphasizing robust analytical and pharmacokinetic (PK) data over traditional comparative efficacy studies (CES). Spanning 17 pages, the document [read more…]
Real World Data in Clinical Trials. Using the EMA guide to Identify suitable external data sources.
The Good Practice Guide for the use of the HMA-EMA Catalogues of Real World Data (RWD) sources and studies has been developed to provide regulators, researchers (including academia and pharmaceutical industry) with recommendations on the use of the catalogues from the perspective of the data user. Specifically, the guide focuses on describing steps and best [read more…]
UK Drug Licensing Applications with MHRA
How to license a medicine for sale in the UK, including national and international routes, and information on fees. ”There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the [read more…]
New EMA Guideline on clinical investigation in the treatment of depression
EMA has published the 3rd revision of the Guideline on clinical investigation of medicinal products in the treatment of depression. This document updates and replaces the previous guideline (EMA/CHMP/185423/2010 Rev. 2). The main focus is on major depressive episodes that occur in the context of MDD. Bipolar and related disorders are separated from depressive [read more…]
Financial advantages of SME status
The European Medicines Agency (EMA) offers full or partial fee exemptions for its pre- and post-authorisation regulatory procedures for micro, small and medium-sized enterprises (SMEs) who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA). Procedure Fee incentives Scientific advice 90% fee reduction for non-orphan products [read more…]
New EU pharmaceutical package legislation
THE PHARMACEUTICAL PACKAGE Widely considered to be the largest overhaul in EU-level pharmaceutical legislation in the last two decades, this package consists of a number of legislative initiatives and non-binding initiatives. Please find an overview of each below as well as key conclusions. Legislative proposals: A Directive on the Union code relating to medicinal products [read more…]