Access and Benefit-Sharing

The Numbers Are In: What Financing has the Nagoya Protocol Delivered for Biodiversity After a Decade?Brazil delays SISGEN 3.0 Foreign-User Functionality while Government Advances alternative pathway for foreign ABS Compliance

Africa

EU Talking Life Sciences Audiocast: Regulatory and Policy Developments from South Africa - SAHPRA's Proposed Black Economic Empowerment (BEE) PolicyEU Talking Life Sciences Audiocast: Developments in the African Medicines Agency and Regulatory Convergence

Agri

EU Biotech Act II: One Week Remaining to Shape the Commission’s Approach

Anti-Corruption

Germany Headed to Stricter Criminal Laws Against “Corruption In The Healthcare Sector”Deferred Prosecution Agreements in the UK: One Step Closer to the Introduction of a New Enforcement Tool in Bribery and Corruption Cases

Artificial Intelligence (AI)

The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology CompaniesNew UK Guidance Clarifies Medical Device Status of AI Scribes

Brazil

Brazil delays SISGEN 3.0 Foreign-User Functionality while Government Advances alternative pathway for foreign ABS ComplianceBrazil declares Açaí a National Fruit: What Are the Real Practical Implications for EU Companies?

Brexit

Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional materialEuropean Commission Proposes to Extend Transitional Periods for In-Vitro-Diagnostic Medical Devices

CE Mark

UK MHRA Announces Consultation on the Indefinite Recognition of CE-marked Medical DevicesUK's Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

Cell-Cultivated Products

UK Launches Food Safety Guidance for Cell-Cultivated Foods

Chemicals

EU Biotech Act II: One Week Remaining to Shape the Commission’s Approach

China

China’s Draft Environmental Code: Access and Benefit-Sharing for Chinese Non-Human Biological Resources – What Life Sciences Companies Should Know

Clinical Trial Applications

The Proposed EU Biotech Act Aims to Accelerate and Streamline Procedures for the Approval of Clinical Trials and Combined StudiesGermany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon

Commercial Structures

EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows - Implications for Global Supply Chains

Compassionate Use

New Early Access and Off-Label Use Rules in FranceBelgium Amends Compassionate Use and Medical Need Program Rules to Expand Access

Competition

Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social MediaEuropean Commission Publishes Exceptional Antitrust Guidance for Undertakings Collaborating to Address the Shortage of Essential Products and Services during COVID-19

Conformity Assessment

UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)

Corporate

The CDA - Five Practical ConsiderationsThe Unintended Consequences of Non-Disclosure Agreements

Corporate Reporting and Disclosures

Brazil delays SISGEN 3.0 Foreign-User Functionality while Government Advances alternative pathway for foreign ABS ComplianceEuropean Commission Publishes “ESRS 2.0” for Public Consultation: Draft Closely Follows EFRAG’s Technical Advice with Additional Simplifications for Companies

Cosmetics

The Numbers Are In: What Financing has the Nagoya Protocol Delivered for Biodiversity After a Decade?Brazil delays SISGEN 3.0 Foreign-User Functionality while Government Advances alternative pathway for foreign ABS Compliance

COVID19

What Companies Should Know About the WHO Pandemic AgreementEU Health Emergency Mechanisms: Impact on Medical Devices

Digital Health

Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkNew German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research

Employment

European Regulators Set Out Data Anonymization StandardsNew Directors’ Remuneration Regime: The Facts for Life Sciences Companies

Environmental & Clean Technology

EU Biotech Act II: One Week Remaining to Shape the Commission’s ApproachNew EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products

EU Pharma Law Revision

EU Announces Political Agreement on Pharma Law ReviewEuropean Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry

EU State aid rules

German Exemptions from Mandatory Rebates for Pharma Companies Are in Line with EU State Aid Rules

European Union

The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology CompaniesEuropean Commission Publishes “ESRS 2.0” for Public Consultation: Draft Closely Follows EFRAG’s Technical Advice with Additional Simplifications for Companies

Export

UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)The Implications of the Windsor Framework

Extended Producer Responsibility

The EPR Obligations of the New Urban Wastewater Treatment Directive: Key Questions and Next Steps for Member StatesNew EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products

Financial

Synthetic Royalty and Drug Development Financings – A Funding Structure Growing in EuropeNon-Dilutive Financing: The U.S. Trend Catching on in Europe’s Life Sciences Sector

Food & Beverage

The Numbers Are In: What Financing has the Nagoya Protocol Delivered for Biodiversity After a Decade?EU Court Confirms No Presumption of Confidentiality for Member State Votes: Covington Prevails in Case C‑540/23 P

Food & Drug Regulatory

What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?The Numbers Are In: What Financing has the Nagoya Protocol Delivered for Biodiversity After a Decade?

Food Labelling

EU Biotech Act II: One Week Remaining to Shape the Commission’s ApproachUK Launches Food Safety Guidance for Cell-Cultivated Foods

Gene Editing

UK Launches Food Safety Guidance for Cell-Cultivated FoodsEU Pharma Legislation Review Series:  GMO Medicines

Global Supply Chain

Historic Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companiesEU Pharma Legislation Review Series: Decentralized Manufacturing

GMOs

EU Biotech Act II: One Week Remaining to Shape the Commission’s ApproachEU Pharma Legislation Review Series:  GMO Medicines

Greenwashing

EU Adopts New Rules on Greenwashing and Social Impact ClaimsEU Pharma Legislation Review Series: Addressing Environmental Risks

HEALTH PRIVACY

New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical ResearchEuropean Health Data Space Published

Healthcare system

What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?

Intellectual Property

European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicinesWhat Companies Should Know About the WHO Pandemic Agreement

Legal Title

EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows - Implications for Global Supply Chains

Life Sciences

The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology CompaniesWhat does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?

M&A

EU Talking Life Sciences Audiocast: Current Trends in M&A and Licensing in the Life Sciences Industry

Maritime

Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences Companies

Marketing authorisation

Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional materialEuropean Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain divided

Medical Devices

The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology CompaniesNew UK Guidance Clarifies Medical Device Status of AI Scribes

Medical Devices

Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkGerman Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects

Medicinal Products

The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology CompaniesWhat does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?

Medicinal Products

What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?U.S.–UK Pharmaceutical Pricing Agreement: Learnings from the Published Text

Miscellaneous

UK Government Announces Launch of Pilot Scheme to Accelerate Access to Innovative Medical DevicesUK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media

Novel Food

EU Biotech Act II: One Week Remaining to Shape the Commission’s ApproachBrazil declares Açaí a National Fruit: What Are the Real Practical Implications for EU Companies?

Patents

European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicinesSingle Market Emergency Instrument: Potential Impact on Medical Devices

Pharma

What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?The Numbers Are In: What Financing has the Nagoya Protocol Delivered for Biodiversity After a Decade?

Pharmaceutical Advertising and Communications

Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social MediaEuropean Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain divided

Pharmaceutical companies

The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology CompaniesWhat does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?

Pharmaceutical Rules

What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?

Privacy & Data Security

Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkNew German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research

Quantum Technologies

Harnessing the complementary power of AI and Quantum Computing

social media

Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social MediaEU Talking Life Sciences Audiocast: Episode 3 – Social Media Challenges for Pharma Companies - Comparing Approaches in Europe and the US

Spain

ABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing Rules

Supply Chain Due Diligence

Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs)

Sustainability

EU Biotech Act II: One Week Remaining to Shape the Commission’s ApproachEuropean Commission Publishes “ESRS 2.0” for Public Consultation: Draft Closely Follows EFRAG’s Technical Advice with Additional Simplifications for Companies

Tax

EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows - Implications for Global Supply Chains

Tax Structures

EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows - Implications for Global Supply Chains

UK

New UK Guidance Clarifies Medical Device Status of AI ScribesNavigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences Companies

UKCA Mark

UK MHRA Announces Consultation on the Indefinite Recognition of CE-marked Medical DevicesMHRA Consults on New UK Pre-Market Medical Device Measures

Uncategorized

Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkGerman Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects

WHO

The World Health Organization’s Emerging Pathogen Access System: Implications for Commercial Infectious Disease R&D