Topics Access and Benefit-Sharing The World Health Organization’s Emerging Pathogen Access System: Implications for Commercial Infectious Disease R&DBrazil declares Açaí a National Fruit: What Are the Real Practical Implications for EU Companies? 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) Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkHarnessing the complementary power of AI and Quantum Computing Brazil Brazil 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 European Commission Publishes “ESRS 2.0” for Public Consultation: Draft Closely Follows EFRAG’s Technical Advice with Additional Simplifications for CompaniesGreen Groceries: Key ESG Issues for the FMCG Industry (including FBOs) Cosmetics Brazil declares Açaí a National Fruit: What Are the Real Practical Implications for EU Companies?ABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing Rules 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 European Commission Publishes “ESRS 2.0” for Public Consultation: Draft Closely Follows EFRAG’s Technical Advice with Additional Simplifications for CompaniesBrazil declares Açaí a National Fruit: What Are the Real Practical Implications for EU 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 EU Court Confirms No Presumption of Confidentiality for Member State Votes: Covington Prevails in Case C‑540/23 PUK Launches Food Safety Guidance for Cell-Cultivated Foods Food & Drug Regulatory EU Biotech Act II: One Week Remaining to Shape the Commission’s ApproachU.S.–UK Pharmaceutical Pricing Agreement: Learnings from the Published Text 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 Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More Work 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 EU Biotech Act II: One Week Remaining to Shape the Commission’s ApproachThe World Health Organization’s Emerging Pathogen Access System: Implications for Commercial Infectious Disease R&D 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 UK MHRA Announces Consultation on the Indefinite Recognition of CE-marked Medical DevicesGermany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More Work 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 Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects Medicinal Products U.S.–UK Pharmaceutical Pricing Agreement: Learnings from the Published TextGermany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies? 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 U.S.–UK Pharmaceutical Pricing Agreement: Learnings from the Published TextGermany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies? 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 World Health Organization’s Emerging Pathogen Access System: Implications for Commercial Infectious Disease R&DGermany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies? Pharmaceutical Rules Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects 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 Navigating 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
