Pathways to Approval : Navigating EU Pharmaceutical Regulation through CP and DCP

Introducing a pharmaceutical product into the European Union (EU) necessitates a thorough understanding of the regulatory pathways for obtaining marketing authorization. This is a critical step for pharmaceutical companies aiming to successfully navigate the complex regulatory framework of the EU. There are two principal pathways to consider: the Centralised Procedure (CP) and the Decentralised Procedure […]

Early Access Programs: A Guide for Pharmaceutical Companies

Early Access Programs (EAPs) are a crucial aspect of the pharmaceutical landscape, providing a pathway for patients with serious or life-threatening conditions to access investigational drugs prior to official approval. For pharmaceutical companies, understanding and effectively managing EAPs can be a game-changer. This blog post will delve into what EAPs entail and how pharmaceutical companies […]

Understanding Prescription Dynamics in France: Branded vs. Generic Medication

The French healthcare system offers a unique framework for prescription drugs, impacting pharmaceutical companies, prescribers, and patients alike. As a pharmaceutical company looking to operate in France, it’s crucial to understand the dynamics between branded and generic medicines, patient preferences, and the implications of the ‘non substitutable’ rule. This understanding is key to developing effective […]

Navigating the French Healthcare Reimbursement System: A guide for Pharmaceutical Companies

The French healthcare system, renowned for its efficiency and universal coverage, presents a unique landscape for pharmaceutical companies looking to expand their market reach. As a pharmaceutical company exploring opportunities in France, it’s imperative to understand the intricacies of the French healthcare insurance system. This system’s structure and operations significantly impact drug pricing, reimbursement, and […]

Oncology in France: Opportunities for Pharma Companies and CROs

The French oncology sector, renowned for its advanced cancer treatment and research facilities, presents a wealth of opportunities for pharmaceutical companies and Contract Research Organizations (CROs) aiming to enter or expand their presence in the French market. This blog post delves into the main cancer centers in France and the current trends, with a focus […]

Navigating the World of Expanded Access Programs (EAP) in Pharma and Biotech

Why Expanded Access is a Game-Changer in Pharma In the dynamic world of pharma and biotech, the spotlight is increasingly on EAP. These programs are not just about bringing medicines to market; they are about bringing hope to patients facing serious or life-threatening diseases. With information more accessible than ever, patients and advocates worldwide are […]

Understanding Exploitant Status vs Establishing your Regulatory Office

Understanding the French Pharmaceutical Landscape As foreign pharmaceutical companies look to expand their reach into the European market, France stands out as a key player. Known for its robust healthcare system and a population keen on high-quality medical care, France offers a promising avenue for growth. However, navigating the regulatory environment can be challenging. A […]

Understanding ”Service Medical Rendu” in the French Healthcare System

The Service Médical Rendu (SMR), or Medical Service Rendered, is a fundamental concept in the French healthcare system, particularly in the context of pharmaceuticals. It is a measure used to evaluate the therapeutic benefit of a medication, which plays a pivotal role in determining its reimbursement by the National Health Insurance (NHI). What is SMR? […]

Navigating the French Healthcare System: Understanding Government Bodies and Their Roles

France’s healthcare system is renowned for its efficiency and effectiveness, providing high-quality medical care to its citizens. This success is largely attributed to the various government bodies that oversee different aspects of healthcare. Understanding the roles and connections of these bodies is crucial for anyone looking to engage with the French healthcare sector. Let’s take […]

Early Access Program in France

In the heart of France’s innovative healthcare landscape, the Early Access Program (EAP), locally known as “Accès Précoce” (formerly “Autorisation Temporaire d’Utilisation” or ATU), stands as a beacon of hope. This remarkable program bridges the gap between urgent patient needs and medical innovation, offering a lifeline to those facing serious or rare diseases with no […]