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.

Belgian Competition Authority Issues Guidance On Information Exchange Between Pharmaceutical Companies For Combination Therapies

On 10 September 2025, the Belgian Competition Authority (the BCA) published a communication clarifying the conditions under which pharmaceutical companies may exchange information...

Belgium Anti-trust

AO

A&O Shearman

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

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

Privacy, Cyber & Data Strategy Advisory | The Data Act: 7 Things To Know About The Data Act And Connected Products

Belgium Privacy

AB

Alston & Bird

Employer Of Record In Belgium: The Flemish Government Clarifies Its Position

Belgium Employment

A

Altius

Building Blocks Of Design Law: CJEU Rules On LEGO Group Modular Design Protection

CM

Crowell & Moring LLP

From Indicia To Duration: Emerging Procedural Themes In EU Dawn Raids

European Union Anti-trust

KL

Herbert Smith Freehills Kramer LLP

The Belgian FDI Screening Mechanism Blows Out Its Second Birthday Candle

Belgium Government

LL

Loyens & Loeff

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

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

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

AI Literacy Becomes Mandatory For Life Sciences Across The EU

The pharma and medtech sectors have a strategic window to implement AI literacy ahead of an August enforcement deadline.

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

Belgium Healthcare

OC

Osborne Clarke

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

The European Commission's comprehensive report on the future of European competitiveness has identified critical challenges facing the pharmaceuticals industry as well as among a range of other sectors across Europe.

European Union Healthcare

OC

Osborne Clarke

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

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

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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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