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.

European Commission Publishes New Variation Guidelines For Medicines

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations ("MA") for medicinal products) ("Variations Guidelines").

European Union Healthcare

AP

Arnold & Porter

Combination Therapies In Belgium: How To Collaborate Without Breaching Competition Law

As the landscape of modern medicine evolves, combination therapies—those that use two or more distinct medicines, often from different companies...

Belgium Anti-trust

A

Altius

European Union And United States Agree On Import Tariffs For Pharmaceutical Products

On 21 August 2025, the European Union and the United States published a Joint Statement (JS) "on a United States-European framework on an agreement on reciprocal...

Worldwide International

VB

Van Bael & Bellis

The New EU "Pharma Package": Interplay With The Critical Medicines Act And Other Shortage Initiatives

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation.

European Union Healthcare

CM

Crowell & Moring LLP

The New EU "Pharma Package": Access Conditionalities And Shortage Measures – A Comparison Of Commission/Parliament/Council Positions

Belgium Healthcare

CM

Crowell & Moring LLP

Commission Guidelines For Providers Of General-purpose AI Models

European Union Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": The "Bolar" Exemption – A Comparison Of Commission/Parliament/Council Positions

European Union IP

CM

Crowell & Moring LLP

REACH Obligation To Register Imported Chemicals May Be Assumed By A Person Other Than The Buyer

European Union Healthcare

A

Altius

Updates To The EU Pharmacovigilance Rules: Key Takeaways For Marketing Authorisation Holders

European Union Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": Global (Orphan) Marketing Authorization

European Union Healthcare

CM

Crowell & Moring LLP

EU Confirms App Stores And Developers Are Subject To Medical Device Laws

European Union Healthcare

OC

Osborne Clarke

EU Consults On New GMP Rules For AI In Pharma Manufacturing

European Union Technology

AP

Arnold & Porter

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

European Union Healthcare

OC

Osborne Clarke

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

European Union Healthcare

OC

Osborne Clarke

The New EU "Pharma Package": Interplay With The Critical Medicines Act And Other Shortage Initiatives

European Union Healthcare

CM

Crowell & Moring LLP

First Informal Guidance Letters On Sustainability-Related Agreements: Key Takeaways From The European Commission

Belgium Environment

AP

Arnold & Porter

Family Office Comparative Guide

Belgium Wealth Mgt

Nijs Draye

EU 2040 Climate Target And Carbon Credits—what's Changing?

European Union Energy

AO

A&O Shearman

Combination Therapies In Belgium: How To Collaborate Without Breaching Competition Law

Belgium Anti-trust

A

Altius

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

Complementary perspectives on the challenges and opportunities shaping healthcare M&A. In Belgium, the implementation of the EU's NIS2 Directive has elevated cybersecurity to a central concern...

Belgium Technology

LL

Loyens & Loeff

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

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security...

European Union Technology

JD

Jones Day

Regulatory Pulse Pharma And Medical Devices Newsletter: Issue #3

The European Health Data Space Regulation (EHDS Regulation) entered into force on March 26, 2025. The purpose of the Regulation is to establish a common framework for the use and exchange...

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

EMA's CHMP Recommends Approval Of Six New Biosimilars

European Union Healthcare

GP

Goodwin Procter LLP

How Medical Technology Is Navigating The AI Act In Europe

Belgium Technology

OC

Osborne Clarke

Belgium Creates A New Legal Exemption For Unauthorised Medicines

Belgium Healthcare

OC

Osborne Clarke

Brussels Enterprise Court Clarifies Requirements For SPC Manufacturing Waiver

In a judgment of December 23, 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024

Belgium Healthcare

AO

A&O Shearman

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

European Union Cannabis

A

Altius

EU Competitiveness Report Pushes For Greener And Digitalised Medical And IVD

The European Commission's report this September on the future of European competitiveness provides critical insights into the economic, regulatory, and technological challenges facing various industries...

European Union Healthcare

OC

Osborne Clarke

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

More than a year ago, the EU Batteries Regulation (Regulation (EU) 2023/1542) entered into force. In approximately one year's time, the EU Batteries Regulation is set to repeal the 2006 Batteries Directive...

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'?

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

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

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

European Union Healthcare

OC

Osborne Clarke

High-Risk AI Systems In Life Sciences Face Strict Regulatory Scrutiny From New EU Rules

European Union Healthcare

OC

Osborne Clarke

New EU AI Act Is Poised To Shape The Future For Life Sciences In Europe

European Union Healthcare

OC

Osborne Clarke

Commission Communication On Biotechnology And Biomanufacturing

European Union Healthcare

AP

Arnold & Porter

Hospital Mergers No Longer Subject To The Belgian Competition Authority's Prior Review

Belgium Anti-trust

A

Altius

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

Belgium Healthcare

A

Altius

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

European Union Government

CM

Crowell & Moring LLP

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

European Union International

A

Altius

Three Changes In Belgian Food Law 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

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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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