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International Trade Health

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

Approved Biosimilar Products Around The world

Please see full chart below for approved biosimilar products around the world. ...more

Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

Journal of Nanobiotechnology Publishes Special Issue on Swiss National Research Program on the “Opportunities and Risks of...

by Bergeson & Campbell, P.C. on

The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64). The editorial states that the...more

Dietary Supplement & Cosmetics Legal Bulletin | July 2017

JAMA Study and Editorial Call for Improvements in Cosmetic Regulation and Surveillance - In response to a study analyzing adverse events for cosmetics and personal care products, the Journal of the American Medical...more

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

On June 30, Congress gaveled out for the July 4 recess after postponing a critical vote to begin debate on an Affordable Care Act (ACA) repeal-and-replace bill. Senate Majority Leader Mitch McConnell (R-KY) and the GOP caucus...more

Ministers Provide Insight on the UK's Position on the Regulation of Medicines post-Brexit

by Hogan Lovells on

With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...more

New UK Brexit Health Alliance Formed

by Hogan Lovells on

A “Brexit Health Alliance” (BHA) has been formed to bring together a diverse range of UK stakeholders in the healthcare industry and provide a single voice for the sector on Brexit-related issues. Members of the BHA include...more

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

by Jones Day on

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

Guidance for European MA Holders to Prepare for Brexit, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice...more

EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, Pharmaceutical & Medical Device Update, Vol....

by Jones Day on

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more

Rx IP Update - June 2017

by Smart & Biggar on

Supreme Court of Canada News - SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more

OFAC Enforcement Trends in the Health Care, Agriculture and Tech Industries

by Baker Donelson on

The United States Department of the Treasury's Office of Foreign Assets Control (OFAC), the U.S. governmental agency tasked with administering and enforcing economic sanctions against hostile targets in furtherance of U.S....more

Unfair and Unbalanced-Episode 20, Roy's Retirement Announcement Edition

by Thomas Fox on

In this episode, I visit with Roy Snell about his recent announcement that he is stepping down as head of the SCCE. We review the current state of the SCCE and how the Roy has seen the compliance evolve from its start after...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

All or Nothing at All: Brexit Update for Life Sciences Companies

by Arnall Golden Gregory LLP on

A lot of ink has been spilled in projecting what Brexit (the UK’s withdrawal from the European Union) might look like, including in this space by this author. The simple fact is that we don’t know what Brexit will actually...more

“Fireball” Malware a Threat to Health Care Industry

A new report released by Check Point has security personnel working in the health care industry particularly concerned and they are warning their colleagues about the existence of “Fireball.”...more

Data Privacy + Cybersecurity Insider - June 2017

by Robinson & Cole LLP on

The American Institute of CPAs (AICPA), has released a risk management reporting framework intended to "establish a common, underlying language for Cybersecurity risk management reporting — almost akin to US GAAP or IFRS...more

Health and Science Projects in Iran

by Dentons on

The Iranian pharmaceutical and healthcare products market has had steady growth during the last decade. There have been significant improvements in living standards in Iran, in particular adequate access to healthcare...more

EMA accepts adalimumab biosimilar applications from Fujifilm Kyowa Kirin and Sandoz, and an infliximab biosimilar application from...

by Goodwin on

Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates. Fujifilm Kyowa Kirin Biologics...more

(Un)Protected Health Information Held for Ransom

by Snell & Wilmer on

Recent experiences of major health care companies offer a reminder of the importance of data security and following a well-written policy for compliance with the HIPAA Privacy Rule....more

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

Despite the headlines coming out of Washington, Congress continues to move forward in regular fashion, discussing and acting upon key issues, such as funding the government, addressing the need to raise the debt ceiling and...more

Recent Healthcare Data Breaches

by Revision Legal on

Healthcare computer systems harbor the most useful three pieces of personal identifying information that can be used for fraud and identity theft – names, Social Security numbers, and dates of birth. With these three pieces...more

European Competition Law Newsletter – June 2017

by McGuireWoods LLP on

EU Regulators Open Pharma Pricing Investigations Focusing on Abuse of Dominance - The European Commission and UK Competition and Markets Authority (CMA) have both opened new investigations into alleged abuses of...more

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