Access and Benefit-Sharing

Soon a new global tax on products developed from “digital information” from biological materials? 5 key takeaways for companies from recent UN negotiationsWIPO proposes new Patent Disclosure obligations on Genetic Resources: What impact for 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

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)

MHRA Outlines New Strategic Approach to Artificial IntelligenceWHO Publishes Regulatory Considerations on AI for Health

Brexit

European Commission Proposes to Extend Transitional Periods for In-Vitro-Diagnostic Medical DevicesNew MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes

CE Mark

UK's Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices

Clinical Trial Applications

Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle

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

European Commission Publishes Exceptional Antitrust Guidance for Undertakings Collaborating to Address the Shortage of Essential Products and Services during COVID-19DEFRA announces raft of new measures to support food supply and key workers in response to 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

New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic ProductsEU Adopts New Rules on Greenwashing and Social Impact Claims

COVID19

EU Health Emergency Mechanisms: Impact on Medical DevicesSingle Market Emergency Instrument: Potential Impact on Medical Devices

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

Environmental, Social and Governance (ESG)

New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic ProductsEU Adopts New Rules on Greenwashing and Social Impact Claims

EU Pharma Law Revision

European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for IndustryEU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and Recast

EU State aid rules

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

European Union

EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025EU Court Overturns EU-wide Botanical Food Ban

Export

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

Extended Producer Responsibility

New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic ProductsGreen Groceries: Key ESG Issues for the FMCG Industry (including FBOs)

Financial

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

Food & Beverage

EU Court Overturns EU-wide Botanical Food BanFood Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules

Food & Drug Regulatory

EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025EU Court Overturns EU-wide Botanical Food Ban

Food Labelling

UK Judge Permits “Raw” Label for Honey

Gene Editing

EU Pharma Legislation Review Series:  GMO MedicinesEU Pharma Legislation Review Series: Addressing Environmental Risks

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

Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesGermany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for "Data Donations" for Research Purposes

Healthcare system

Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesGermany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations

Intellectual Property

UK HRA Consults on a New Model Investigator-Initiated Study AgreementWIPO proposes new Patent Disclosure obligations on Genetic Resources: What impact for companies?

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 Court Overturns EU-wide Botanical Food BanEU Talking Life Sciences Audiocast: Regulatory and Policy Developments from South Africa - SAHPRA's Proposed Black Economic Empowerment (BEE) Policy

M&A

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

Marketing authorisation

EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes

Medical Devices

UK's Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices

Medical Devices

MHRA Consults on New UK Pre-Market Medical Device MeasuresUK's Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

Medicinal Products

EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025New ABPI Code and PMCPA Constitution and Procedure Published

Medicinal Products

Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesGermany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations

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

Single Market Emergency Instrument: Potential Impact on Medical DevicesEU Talking Life Sciences Audiocast: Supplementary Protection Certificates – What It Means for a Product to Be Protected by a Basic Patent in Force and Future Proposals in the EU

Pharma

New ABPI Code and PMCPA Constitution and Procedure PublishedGermany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

Pharmaceutical Advertising and Communications

New ABPI Code and PMCPA Constitution and Procedure PublishedConsultation on Changes to the ABPI Code and UK Advertising Complaints Process

Pharmaceutical companies

Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesGermany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations

Pharmaceutical Rules

New ABPI Code and PMCPA Constitution and Procedure PublishedEuropean Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry

Privacy & Data Security

Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesThe New Italian Sunshine Act: What Companies Should Know And How To Get Ready

social media

EU Talking Life Sciences Audiocast: Episode 3 – Social Media Challenges for Pharma Companies - Comparing Approaches in Europe and the USUK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media

Supply Chain Due Diligence

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

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

UKCA Mark

MHRA Consults on New UK Pre-Market Medical Device MeasuresUK's Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

Uncategorized

Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesNew EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products