News & Analysis as of

Data Protection Regulatory Requirements Pharmaceutical Industry

Smart & Biggar

Health Canada releases its Statistical Report 2024/2025 for PMNOC Regulations, data protection and CSPs

Smart & Biggar on

On July 25, 2025, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food...more

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

Gardner Law on

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

A&O Shearman

Council position on EU pharma package adopted

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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’. The pharma package now moves to the next...more

Hogan Lovells

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

Hogan Lovells on

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

A&O Shearman

China advances pharmaceutical data protection regime with new Draft Measures

A&O Shearman on

On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

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The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Ropes & Gray LLP

China Formalizes Regulatory Data Protection Mechanism

Ropes & Gray LLP on

Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

Womble Bond Dickinson

[Webinar] Innovation Interchange Summit: The Power Of Cross-Industry Insight - May 16th, 11:00 am - 4:00 pm ET

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Powerful ideas emerge when you look at something through a completely different lens. And when two parties come together to share those unique perspectives? That’s when the magic happens. Womble Bond Dickinson’s virtual...more

Foley & Lardner LLP

Key Contractual Considerations for Health AI and Hospital Collaborations

Foley & Lardner LLP on

If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative...more

Morgan Lewis - Tech & Sourcing

Important Considerations When Tech Service Providers and Life Science Companies Collaborate in the Digital Health Space

When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Philadelphia Regional Conference - May 29th, 8:30 am - 4:30 pm EDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

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