Belgium: Life Sciences, Biotechnology & Nanotechnology

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

EU Consults On New GMP Rules For AI In Pharma Manufacturing

On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing.

European Union Technology

AP

Arnold & Porter

European Commission Consultation Shapes High-risk AI Classification For Life Sciences In The EU

Stakeholder input will influence guidelines for AI Act implementation in healthcare and medical technologies

European Union Healthcare

OC

Osborne Clarke

EU Guidance Details How Technical And Clinical Standards Converge For AI In Medtech

FAQ explains research exemption, dual conformity assessment and clinical data obligations for devices and diagnostics

European Union Healthcare

OC

Osborne Clarke

Council Position On EU Pharma Package Adopted

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package'.

European Union Healthcare

AO

A&O Shearman

Trends In Life Sciences M&A: Cybersecurity And AI Take Center Stage

Belgium Technology

LL

Loyens & Loeff

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

European Union Technology

JD

Jones Day

Regulatory Pulse Pharma And Medical Devices Newsletter: Issue #3

European Union Healthcare

SJ

Steptoe LLP

The New Belgian Government's Public Health Policy: 10 Key Take-Aways For Pharma Policy

Belgium Healthcare

A

Altius

CJEU's DocMorris Ruling: Where Is The Line For Pharmaceutical Advertising?

Belgium Healthcare

A

Altius

European Commission Publishes Proposal For EU Critical Medicines Act

European Union Healthcare

AP

Arnold & Porter

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 119

European Union Technology

JD

Jones Day

New Year, New Policy: CPVO Updates Its Public Access To Documents Policy

A

Altius

AI Literacy Becomes Mandatory For Life Sciences Across The EU

Belgium Healthcare

OC

Osborne Clarke

Brussels Enterprise Court Clarifies Requirements For SPC Manufacturing Waiver

Belgium Healthcare

AO

A&O Shearman

Less Than A Year To Go For The Transposition Of The EU Pay Transparency Directive: Overview Of The Draft National Implementations

European Union Employment

VO

Van Olmen & Wynant

Labour and Employment Comparative Guide

Belgium Employment

AdLex Advocaten & Bemiddelaars

Goodwin Antitrust & Regulatory Shorts: Fashion Faux Pas; Misleading Green And Social Responsibility Claims

Belgium Consumer

GP

Goodwin Procter LLP

The New EU "Pharma Package": Regulatory Data Protection – A Comparison Of Commission/Parliament/Council Positions

European Union Privacy

CM

Crowell & Moring LLP

Procurement Of Medical Devices: New Measures Between The EU And China

Belgium Government

A

Altius

EMA's CHMP Recommends Approval Of Six New Biosimilars

The European Medicines Agency's (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars.

European Union Healthcare

GP

Goodwin Procter LLP

How Medical Technology Is Navigating The AI Act In Europe

AI is revolutionizing medical products and manufacturing, from remote surgery to diagnostics, prompting regulators to catch up. The EU AI Act, effective since August, aims to address the industry's evolving challenges. Experts discuss its potential impact on medical technology.

Belgium Technology

OC

Osborne Clarke

Belgium Creates A New Legal Exemption For Unauthorised Medicines

A novel form of 'named patient use' mechanism is meant to address special pharma needs and drug shortages

Belgium Healthcare

OC

Osborne Clarke

CJEU C-793/22 Biohemp – Indoor Cannabis Cultivation: The CJEU Weighs In

The Cannabis sativa L. plant serves a wide range of purposes, many of which are uncontroversial. It can be grown in the EU, in which context it is commonly called ‘hemp'.

European Union Cannabis

A

Altius

EU Enforces Stricter Liability For Life Sciences Products

European Union Consumer

OC

Osborne Clarke

Medtech Sector Faces New EU 'Green Deal' Recommendations

European Union Healthcare

OC

Osborne Clarke

Belgium Advances Digital Health As Its Parliament Calls For Action

Belgium Healthcare

OC

Osborne Clarke

Draghi Report On EU Competitiveness Offers New Recommendations For Pharma And Biotech

European Union Healthcare

OC

Osborne Clarke

EU Competitiveness Report Pushes For Greener And Digitalised Medical And IVD

European Union Healthcare

OC

Osborne Clarke

The EU Batteries Regulation: Taking Stock Of The New EU Battery Requirements

European Union Environment

CM

Crowell & Moring LLP

Preparing For The EU's New Approach To Critical Medicines And Medicine Shortages: A New 'Critical Medicines Act'?

European Union Healthcare

CM

Crowell & Moring LLP

The Impacts Of The EU Data Act On Medical And Health Devices Companies

European Union Healthcare

SJ

Steptoe LLP

EU AI Act's 'Deployers' Definition Has Wide-ranging Significance For Life Sciences

European Union Healthcare

OC

Osborne Clarke

Low-Risk AI Bears High Stakes For Digital Health In New EU Regulation

European Union Healthcare

OC

Osborne Clarke

Preparing For The EU's New Approach To Critical Medicines And Medicine Shortages: A New 'Critical Medicines Act'?

The EU legal and policy framework regarding critical medicines and medicine shortages is rapidly changing. In the past 12 months alone, there have been numerous developments...

European Union Healthcare

CM

Crowell & Moring LLP

The Impacts Of The EU Data Act On Medical And Health Devices Companies

The EU Data Act will be applicable from September 12, 2025. Given the consequent steps that will be required to comply with the EU Data Act...

European Union Healthcare

SJ

Steptoe LLP

EU AI Act's 'Deployers' Definition Has Wide-ranging Significance For Life Sciences

dentifying businesses as deployers of high-risk AI systems is crucial for understanding new regulatory responsibilities

European Union Healthcare

OC

Osborne Clarke

Low-Risk AI Bears High Stakes For Digital Health In New EU Regulation

At the heart of the new European regulation laying down harmonised rules on artificial intelligence (AI) is a focus on high-risk AI systems and their stringent governance.

European Union Healthcare

OC

Osborne Clarke

A New CE Marking For European Healthcare: When And Why?

European Union Healthcare

OC

Osborne Clarke

Changes In The Law On Marketing Of Veterinary Medicines: What You Need To Know

Belgium is welcoming a significant development in the field of veterinary medicine law. The Act of 11 July 2023 containing various provisions on health, which entered into force on 8 September 2023...

Belgium Healthcare

A

Altius

2024: An Overview Of New And Upcoming Belgian And EU Laws And Regulations

A number of important Belgian and EU legislative changes are likely to have an impact in 2024. On the one hand, there are new laws that have been adopted and will start to bite...

European Union Government

CM

Crowell & Moring LLP

EU Court Of Justice: Parallel Importer May Not Remove PPP Batch Number

On 7 December 2023, the EU Court of Justice (‘CJEU') handed down its ruling in case C-830/21 between Syngenta Agro GmbH (‘Syngenta Agro') and Agro Trade Handelsgesellschaft...

European Union International

A

Altius

Three Changes In Belgian Food Law In 2023

Food law is extensively harmonized throughout the EU, but national law still has a role to play. In this short article, we look at three developments in Belgian food law that have taken place in 2023...

Belgium Healthcare

A

Altius

Belgium Aims For Hospitals To Increase Their Biosimilars Uptake

Belgium Healthcare

A

Altius

Reversal Of Burden Of Proof Under Proposal For A New EU Product Liability Directive

European Union Consumer

JD

Jones Day

EMA Adopts Revised CTIS Transparency Rules

European Union Privacy

CL

Cooley LLP

WEBINAR VIDEO | Navigating Mergers And Acquisitions In Life Sciences: Insights For Success And Pitfalls To Avoid

Belgium Healthcare

A

Altius

New Product Liability Regime On The Way

European Union Consumer

A

Altius

European Commission Adopts Directive Extending Time Lead Can Be Used In PVC Sensors Of IVDs

European Union Healthcare

CL

Cooley LLP

European Commission Publishes MDR And IVDR Factsheet For Non-EU/EEA Countries

European Union Healthcare

CL

Cooley LLP

European Parliament Adopts Its Version Of AI Act

European Union Technology

AP

Arnold & Porter

Belgian Medicines Agency Announces Stricter Monitoring Of Negative Formulations On Medicines Packaging

Belgium Healthcare

A

Altius

Belgium Garners European Support For Initiative To Improve Security Of Medicines Supply In Europe

European Union Healthcare

VB

Van Bael & Bellis

Drug & Medical Device Litigation 2023

European Union Healthcare

CL

Cooley LLP

European Health Data Space - Untapping The Potential Of EU Health Data

European Union Healthcare

T

Timelex

The Council Of The European Union Votes In Favor Of Amending The Transitional Provisions In The MDR And IVDR

European Union Healthcare

CL

Cooley LLP

EMA Launches Pilot Program For Expert Panel Scientific Advice In Relation To Certain High-risk Devices

Belgium Healthcare

CL

Cooley LLP

Unveiling The Complexity Of The Belgian MedTech Legal Landscape

Belgium Healthcare

CM

Crowell & Moring LLP

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Latest Videos

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What Regulatory Challenges Are Facing The Life Sciences Sector? (Video)

WF

William Fry

Webinar Video | Lunch & Learn: Life Sciences : Morceaux Choisis

A

Altius

Webinar Video | Life Sciences Session #2: Vaccine Liability: What If Vaccination Goes Wrong?

A

Altius

Launch Of Our Medical Device Publication (Video)

WF

William Fry

Understanding Sunshine Rules: How New Transparency Regulations In Europe Are Changing Relationships Between Industry And Health Care Professionals (Video)

HL

Hogan Lovells

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