Topics Access and Benefit-Sharing Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences CompaniesABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing Rules 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 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 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 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 Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs) Cosmetics ABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing RulesThe Cali Fund and Why Legal Certainty Matters for Life Sciences R&D 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 New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic ProductsHistoric Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companies 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 Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences CompaniesEuropean Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicines 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 Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences CompaniesEU Court Confirms No Presumption of Confidentiality for Member State Votes: Covington Prevails in Case C‑540/23 P Food Labelling UK Launches Food Safety Guidance for Cell-Cultivated FoodsUK Judge Permits “Raw” Label for Honey 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 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 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 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 Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences CompaniesThe Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology Sector 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 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 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 Medicinal Products German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospectsEuropean Commission Adopts Proposal for the Biotech Act Medicinal Products German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospectsInfluencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media 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 Food Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules 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 The Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology SectorGerman Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects 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 Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology SectorGerman Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects Pharmaceutical Rules German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospectsInfluencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media 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 An EU Biodiversity Market by 2027? The new EU’s Roadmap towards Nature CreditsThe EPR Obligations of the New Urban Wastewater Treatment Directive: Key Questions and Next Steps for Member States 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
