Articles
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EMA’s PRIME Scheme vs. MHRA’s ILAP
Comparative Analysis: EMA’s PRIME Scheme vs. MHRA’s ILAP Navigating Accelerated Pathways for Innovative Medicines in the EU and UK The European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) scheme and the Medicines and Healthcare products Regulatory…
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UK Clinical Trials Revamp: MHRA Launches Route B for Low-Risk Amendments
Key summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pivotal pilot program today, October 1, 2025, as part of the rollout for the UK’s updated clinical trials framework. This “Route B…
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Reflection Paper on a Tailored Clinical Approach in Biosimilar Development out for consultation
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…
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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…
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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…
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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…
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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…
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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…
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Regulatory and Market Access Parallel Consultation (CHMP/EUnetHTA)
Pharma Design Ltd has been a supporter of integrated Regulatory and Market Access advice in EU since its foundation in 2009. The progress made since then on a parallel EMA and HTA assessment is therefore…
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Top 5 issues to look out for in the access to medicines debate in Europe
For pharmaceuticals in Europe, 2016 marked a turning point. For the first time, in a frank and comprehensive dialogue, all the problems and deficiencies of the current business model were finally brought centre stage and…