Life Sciences and Healthcare

Navigating Belgium's life sciences terrain: a strategic overview

Published on 13th Mar 2024

Insights into regulations, trends, and strategic pathways for the pharmaceutical, medical device and food (supplement) industries

In a Q&A published in early March 2024, lawyers within our Life Sciences and Healthcare team offer a comprehensive summary of insights into Belgium's dynamic ecosystem.

The paper (see below for a full link) examines the regulatory framework governing Belgium's landscape, spanning pharmaceuticals, medical devices and in vitro diagnostics to foodstuffs and food supplements. Taking the form of a resource guide, the report provides insights into the regulatory processes governing these sectors, from research and development through market approval or notifications to post-marketing vigilance, ensuring compliance with stringent standards and procedures.

Additionally, the document outlines the ongoing obligations required after obtaining marketing authorisation for medicinal products or conducting conformity assessments for medical devices, highlighting the responsibilities of competent national authorities such as the Federal Agency for Medicines and Health Products (FAMHP). Foodstuffs and food supplements, and the involvement of local regulators such as the Federal Public Service Health, Food Chain Safety and Environment (FPS Health) and the Federal Agency for the Safety of the Food Chain (FASFC) are also addressed

Challenging regulatory decisions, navigating clinical trials or medical device studies, and addressing manufacturing authorisation are among the key topics covered in the handbook, offering a comprehensive understanding of the legal landscape in Belgium. It explores distribution processes, production, advertising regulations, patents, trademarks, and product liability regimes, providing actionable insights for stakeholders in the sector. Moreover, the guide examines recent trends indicating a shift towards digitisation and the use of artificial intelligence, shaping Belgium's evolving healthcare system and food industry practices.

Access the guide here.

Osborne Clarke's comment

With a focus on emerging compliance standards, advancements in digital health applications, and evolving market trends, the Q&A serves as a strategic resource for industry professionals, policymakers, and stakeholders seeking to understand and capitalise on opportunities in Belgium's vibrant Life Sciences and Healthcare ecosystem.

 

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* This article is current as of the date of its publication and does not necessarily reflect the present state of the law or relevant regulation.

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