News & Analysis as of

International Trade Health

Read need-to-know updates, commentary, and analysis on International Trade issues written by leading professionals.

Sandoz’s Biosimilars Rituximab and Etanercept are Recommended for Approval in Europe

by Goodwin on

On Friday, April 21, 2017, Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sandoz’s biosimilars rituximab and etanercept in Europe. If approved, rituximab may be...more

An Opportunity to Shape Compliance with GDPR

by Hogan Lovells on

A close observer of the GDPR will have noticed that, in several places, individual EU Member States can implement derogations from the GDPR requirements. Of course, as a regulation under EU law there is less scope for local...more

Port-of-Entry Inspections and NAFTA Professional (TN) Visas: Differential Diagnosis for Advance Practice Nurses

Since President Trump first issued his executive order suspending travel to the United States by certain foreign nationals, a flood of generalized reports regarding changes to U.S. port-of-entry inspection operations emerged....more

Long-Running Corruption Scheme Exposed in Brazil: Operation "Exposed Invoice" Provides Continuous Improvement Opportunity for...

by Pepper Hamilton LLP on

A massive scheme involving medical products sales to Brazilian public entities has led to recent high-profile arrests. The events highlight the importance to a well-functioning compliance program of keeping up with new...more

What’s New in Washington: 10 Things You Need to Know

Congress entered into its spring recess on April 7 having delivered regulatory reforms to President Trump’s desk. In the first 75 days of the Trump administration, legislators approved 13 Congressional Review Act resolutions,...more

GCP Renovation ICH Reflection on "GCP Renovation"

by Jones Day on

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") has released a reflection paper on Good Clinical Practice ("GCP") "Renovation," which contains the ICH proposal...more

EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

by Jones Day on

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending...more

EMA Consultation on the Revised Policy on Access to Documents

by Jones Day on

The EMA has launched a public consultation on the proposed revision to its policy on access to documents...more

Ten Years of Conditional Marketing Authorizations

by Jones Day on

The European Medicines Agency ("EMA") published a report ("EMA report") concerning the data collected over 10 years—between July 2006 and June 2016—on the so-called "conditional marketing authorizations" ("CMAs")....more

EU Addresses the Use of Nanomaterials in Medical Devices

by Bergeson & Campbell, P.C. on

On April 5, 2017, the European Parliament (EP) approved a regulation on medical devices, as well as a regulation on in vitro diagnostic medical devices. The EP’s April 5, 2017, press release states that the medical devices...more

Guest Post – Come Together: Is UK Product Liability Law Getting More Like the U.S.?

by Reed Smith on

This guest post – only our second post ever on European issues is brought to you by Reed Smith partners Marilyn Moberg and (in the UK) associate Bond, Kathryn Bond (sorry, couldn’t resist). Our previous (and only) foray into...more

Sally Yates’ was Already Famous for Changing the Focus of Compliance Investigations - The Yates Memorandum

by Ruder Ware on

By now the whole world knows about Sally Yates. We are likely to see a lot more of her as a central figure in Congressional investigations. For some of us who deal with compliance investigations, Sally Yates was famous long...more

Boston Scientific Announces Acquisition of Symetis for $435 Million

Boston Scientific Corporation recently announced an agreement to purchase Swiss medical device maker Symetis SA for $435 million in up-front cash.  The acquisition is expected to close in the second quarter of 2017....more

French Companies Must Show Duty of Care for Human and Environmental Rights

by Morgan Lewis on

After the Constitutional Court rendered its recent decision on the law regarding the duty of care of parent companies and ordering companies, the rule has finally entered into force—but is it much ado about nothing?...more

Purchase of expensive drugs from outside the EU: did AIFA open the Pandora’s box?

by Hogan Lovells on

By Ministerial Circular of 23 March 2017, AIFA clarified the conditions under which unauthorized medicinal products may be purchased abroad further to the procedure laid down by the Ministerial Decree of 11 February 1997....more

New Research Shows Potential to Prevent Medical Device-Related Infections

A research team from Trinity College Dublin has recently discovered a way to reduce the incidence of medical device-associated infection resulting from biofilms. The term “biofilms” refers to organized colonies of bacteria...more

Your Cyber Minute: What to keep in mind as a litigator  [Video]

by Hogan Lovells on

Partners Harriet Pearson and Michelle Kisloff talk about the real-time challenges of data breaches in the context of litigation and investigations. Hear the three major things you need to do and how to avoid the common...more

Medicinal Products: the EU and the US Mutually Recognize Manufacturing Standards

by K&L Gates LLP on

The European Union (“EU”) and the United States (“US”) have reached a sectoral agreement (the “Agreement”) that will greatly ease the administrative burden when proving compliance with Pharmaceutical Good Manufacturing...more

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

by Fish & Richardson on

Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

by Butler Snow LLP on

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

Health Company Fined by UK’s Information Commissioner Office

by Hogan Lovells on

Last week, the UK’s Information Commissioner’s Office (ICO) published a monetary penalty notice which fined a private healthcare company, HCA International, £200,000 for its failure to keep sensitive data secure....more

What’s New in Washington: 10 Things You Need to Know

The Trump administration and Congress continue to take on a new shape. The Presidential Transition Team officially shut its U.S. General Services Administration office on February 28, 2017, and the remaining staff moved to...more

Limiting Extraterritorial Reach of U.S. Patents: "Substantial" Means More than One

by Foley Hoag LLP on

Last week, the Supreme Court provided much-needed clarity to U.S. companies concerned about their potential liability for supplying a single component of a multicomponent invention abroad. The Court’s decision in Life...more

617 Results
|
View per page
Page: of 25
Cybersecurity

Follow International Trade Updates on:

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.

Feedback? Tell us what you think of the new jdsupra.com!